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HIIT vs MICT During Pregnancy and Health and Birth Outcomes in Mothers and Children (HIIT MAMA)

Primary Purpose

Pregnancy, Postpartum, Childbirth

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
High intensity interval training program for pregnant women
Moderate intensity continuous training program for pregnant women
Standard obstetric care with extended education on healthy lifestyle
High intensity interval training program for nonpregnant women
Moderate intensity continuous training program for nonpregnant women
Standard health care with extended education on healthy lifestyle
Sponsored by
Gdansk University of Physical Education and Sport
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pregnancy focused on measuring Pregnant women, Prenatal care, Postpartum women, Postnatal care, Exercise, Physical activity, Exercise intervention, Educational intervention, Exercise test, High-intensity interval training, Moderate-intensity continuous training, Health Status, Physical fitness, Childbirth, Birth outcomes, Infant, Child

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Criteria: Inclusion Criteria:

For pregnant women:

  1. course of pregnancy allowing participation in physical activities adapted to pregnant women
  2. consent of the obstetric care provider to participate in the study tests and exercise classes;
  3. taking part in all diagnostic and control tests to assess selected biological, functional and psychological parameters at each trimester of pregnancy, during the puerperium and one year after childbirth;
  4. participant's consent to use data from the medical documentation on the course of childbirth and the assessment of the new-born, as well as the results of preventive examinations in children aged one, two, four and six, routinely performed according to the Polish pediatric care system;
  5. availability to participate in classes three times a week until the day of delivery;
  6. declaration of participation in postpartum classes at least once a week and self-completion of the exercise program according to written instructions prepared by the exercise specialist;
  7. women can participate in the exercise programs regardless of their level of fitness or exercise capacity, as well as the level of motor skills (based on the diagnostic exercise tests, the exercise program will be tailored to the individual needs and capabilities of a woman).

For nonpregnant women:

  1. nulliparous;
  2. lack of diagnosed infertility and other disorders of the reproductive system;
  3. taking part in all diagnostic and control tests to assess selected biological, functional and psychological parameters at indicated time points: before and after each of the 8-week exercise program during the first 8 months of the study and once every 3 months during the following twelve months of the study
  4. declaration of availability to participate in exercise classes three times a week for the first 8 months of the program (attendance at least 80% is required);
  5. declaration of participation in classes at least once a week and self-completion of the exercise program to the required 150 minutes of physical activity per week, according to the written guidelines prepared by the instructor, for the next 12 months of the program;
  6. women can participate in the exercise program regardless of their level of fitness or exercise capacity, as well as the level of motor skills (based on the diagnostic exercise tests, the exercise program will be tailored to the individual needs and capabilities of a woman).

Exclusion Criteria for Pregnant and Nonpregnant Women:

  1. contraindications to increased physical effort or to any of the diagnostic or control tests;
  2. allergies to materials used during diagnostic and control tests (e.g. nickel present in steel plates of vaginal electrodes, disinfectants);
  3. other conditions that, according to the researchers, will threaten the health or safety of the participants or will significantly affect the quality of the collected data.

Sites / Locations

  • Laboratory of Physical Effort and Genetics in Sport at Gdansk University of Physical Education and SportRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Sham Comparator

Experimental

Active Comparator

Sham Comparator

Arm Label

Pregnant HIIT group

Pregnant MICT group

Pregnant standard care group

Nonpregnant HIIT group

Nonpregnant MICT group

Nonpregnant standard care group

Arm Description

The high intensity interval training (HIIT) program will be implemented according to the World Health Organization guidelines on physical activity and sedentary behavior (2020) and on the recommendations on physical activity and exercise during pregnancy and postpartum period published by the American College of Obstetricians and Gynecologists (2020). The program will be also based on the "High-Intensity Interval Training for Cardiometabolic Disease Prevention" report by American College of Sports Medicine (2019). During the study, the participant will be under standard obstetric care on her own. She is obliged to inform her obstetric care provider about participation in the HIIT program and to provide feedback to the project coordinator as to possible recommendations of the obstetric care provider regarding the exercise.

The moderate intensity continuous training (MICT) program will be implemented based on the World Health Organization guidelines on physical activity and sedentary behavior (2020) and on the recommendations on physical activity and exercise during pregnancy and postpartum period published by the American College of Obstetricians and Gynecologists (2020). During the study, the participant will be under standard obstetric care on her own. She is obliged to inform her obstetric care provider about participation in the MICT program and to provide feedback to the project coordinator as to possible recommendations of the obstetric care provider regarding the exercise.

During the study, the participant will be under standard obstetric care on her own. She is obliged to inform her obstetric care provider about participation in the HIIT Mama study and to provide feedback to the project coordinator as to possible contraindications to taking part in the study tests.

The high intensity interval training (HIIT) program will be implemented according to the World Health Organization guidelines on physical activity and sedentary behavior (2020) and on the "High-Intensity Interval Training for Cardiometabolic Disease Prevention" report by American College of Sports Medicine (2019). During the study, the participant will be under standard health care on her own. She is obliged to inform her health care provider about participation in the HIIT Mama study and to provide feedback to the project coordinator as to possible contraindications to exercise or taking part in the study tests.

The moderate intensity continuous training program will be implemented according to the World Health Organization guidelines on physical activity and sedentary behavior (2020). During the study, the participant will be under standard health care on her own. She is obliged to inform her health care provider about participation in the HIIT Mama study and to provide feedback to the project coordinator as to possible contraindications to exercise or taking part in the study tests.

During the study, the participant will be under standard health care on her own. She is obliged to inform her health care provider about participation in the HIIT Mama study and to provide feedback to the project coordinator as to possible contraindications to exercise or taking part in the study tests.

Outcomes

Primary Outcome Measures

Changes in maternal oxygen consumption, during and after pregnancy
Changes from the baseline maternal oxygen consumption (VO2; ml/min), including the maximal oxygen consumption (VO2max) values in a progressive maximal exercise test on a cycloergometer with electronically regulated load, using stationary respiratory gas analyzer. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters.
Changes in maternal heart rate, during and after pregnancy
Changes from the baseline heart rate (HR; beats per minute), including the maximal HR values, in a progressive maximal exercise test on a cycloergometer with electronically regulated load, using heart rate monitor. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters.
Changes in systolic blood pressure, during and after pregnancy
Changes from the baseline maternal systolic blood pressure (SBP; mm Hg), in a progressive maximal exercise test on a cycloergometer with electronically regulated load, using electronic blood pressure monitor. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters.
Changes in diastolic blood pressure, during and after pregnancy
Changes from the baseline maternal diastolic blood pressure (DBP; mm Hg), in a progressive maximal exercise test on a cycloergometer with electronically regulated load, using electronic blood pressure monitor. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters.
Changes in blood glucose level, during and after pregnancy
To assess the changes in glucose levels (mg/dl) the blood samples will be taken on the day of the maximal exercise capacity test before the test (at fasting condition), immediately (approx. 1 min) after completion the test and approx. 40 min. after the test. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially related to metabolism and changing with regular exercise in the perinatal period.
Changes in triglycerides, during and after pregnancy
Changes in triglycerides (TG; mg/dl) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially related to metabolism and changing with regular exercise in the perinatal period.
Changes in high-density lipoproteins, during and after pregnancy
Changes in high-density lipoproteins (HDL; mg/dl) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially related to metabolism and changing with regular exercise in the perinatal period.
Changes in urea, during and after pregnancy
To assess the changes in urea levels (ml/dl), the study participants will collect urine samples to standard urine containers on the day of the maximal exercise capacity test before the test (at fasting condition), immediately after completion the test (up to 15 min) and approx. 60 min after the test. The investigators will analyze changes in this parameter in terms of intervention mode and its relationship with other selected parameters, potentially related to renal function and changing with regular exercise in the perinatal period.
Changes in creatinine, during and after pregnancy
To assess the changes in creatinine levels (ml/dl), the study participants will collect urine samples to standard urine containers on the day of the maximal exercise capacity test before the test (at fasting condition), immediately after completion the test (up to 15 min) and approx. 60 min after the test. The investigators will analyze the changes in this parameter in terms of intervention mode and its relationship with other selected parameters, potentially related to renal function and changing with regular exercise in the perinatal period.
Changes in maternal weight, during and after pregnancy
Changes in maternal weight will be expressed in kilograms (kg). The investigators will analyze the changes in this parameter in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Changes in maternal Body Mass Index during and after pregnancy
Changes in Body Mass Index (BMI, kg/m2) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Changes in maternal neuromuscular activity of pelvic floor muscles, during and after pregnancy
The neuromuscular activity of pelvic floor muscles (µV) will be evaluated with surface electromyography with a vaginal probe, in the condition of synergistic muscle relaxation. The investigators will analyze the changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially related to pelvic floor function and changing with regular exercise in the perinatal period.
Changes in the Incontinence Impact Questionnaire score, during and after pregnancy
The urinary incontinence symptoms will be assessed using the scale of incontinence impact on the quality of life based on the Incontinence Impact Questionnaire - short form (Uebersax et al., 1995; IIQ-7 score; minimum score: 0; maximum score: 100; higher scores mean worse outcome). The investigators will analyze the changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially related to pelvic floor function and changing with regular exercise in the perinatal period.
Changes in the Urogenital Distress Inventory score, during and after pregnancy
The pelvic floor disorders will be assessed using the scale based on the Urogenital Distress Inventory - short form questionnaire (Uebersax et al., 1995; UDI - 6 score; minimum score: 0; maximum score: 100; higher scores mean worse outcome). The investigators will analyze the changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially related to pelvic floor function and changing with regular exercise in the perinatal period.
Changes in the inter-rectus distance, during and after pregnancy
The changes in the inter-rectus distance (IRD, mm) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Changes in the center of pressure excursions (static balance), during and after pregnancy
The changes in the excursions of the center of pressure (COP; mm) will be measured in standing position using a specialized force platform. The changes in the static balance will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Changes in lumbar spine mobility, during and after pregnancy
The changes in the lumbar spine mobility (°) will be measured in standing position using specialized motion detectors and software. The changes lumbar spine mobility will be analyzed in terms of intervention mode and in relation to other selected parameters, potentially changing with regular exercise in the perinatal period.
Changes in cervical spine mobility, during and after pregnancy
The changes in the cervical spine mobility (°) will be measured in sitting position using specialized motion detectors and software. The changes lumbar spine mobility will be analyzed in terms of intervention mode and in relation to other selected parameters, potentially changing with regular exercise in the perinatal period.
Changes in foot loading, during and after pregnancy
The changes in foot loading (kPa) will be measured in standing position using plantar pressure measurements platform and software. This outcome will be analyzed in terms of intervention mode and in relation to other selected parameters, potentially changing with regular exercise in the perinatal period.
Changes in spatiotemporal gait parameters: step length, during and after pregnancy
The changes in the step length (m) will be measured in walking using plantar pressure measurements platform and software. This outcome will be analyzed in terms of intervention mode and in relation to other selected parameters, potentially changing with regular exercise in the perinatal period.
Changes in spatiotemporal gait parameters: step width, during and after pregnancy
The changes in the step width (m) will be measured in walking using plantar pressure measurements platform and software. This outcome will be analyzed in terms of intervention mode and in relation to other selected parameters, potentially changing with regular exercise in the perinatal period.
Changes in the hand grip strength, during and after pregnancy
The hand muscle strength (kg) will be assessed using the electronic hand grip dynamometer. The participant will perform the test separately for the right and left hands.
Changes in the pressure pain tolerance in the hand area, during and after pregnancy
The pressure pain tolerance (PTOL) will be assessed using a computerized pressure algometer in the hand area. The PTOL will be expressed in the value of applied pressure (kPa). The pain test will be performed before and immediately (up to 15 minutes) after the maximal exercise test on a cycloergometer. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Changes in the pressure pain tolerance in the forearm area, during and after pregnancy
The pressure pain tolerance (PTOL) will be assessed using a computerized pressure algometer in the forearm area. The PTOL will be expressed in the value of applied pressure (kPa). The pain test will be performed before and immediately (up to 15 minutes) after the maximal exercise test on a cycloergometer. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Changes in number of errors in the Stroop Interference test (version S8: congruent/incongruent), during and after pregnancy
The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Changes in reaction time based on the Stroop Interference test (version S8: congruent/incongruent), during and after pregnancy
The time spent to complete each task, as well as the total time (s) to complete the Stroop Interference test will be assessed. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Changes in the Beck Depression Inventory - II score, during and after pregnancy
The occurrence and severity of depression symptoms using the scale of the Beck Depression Inventory - II (Beck et al., BDI -II score; minimum score: 0; maximum score: 63; higher scores mean worse outcome).The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Changes in the Fear of Childbirth questionnaire scores, during and after pregnancy
The fear of childbirth will be assessed using a scale based on the Fear of Childbirth scale questionnaire (Areskog et al., 1992; minimum score: 0; maximum score: 63; higher scores mean worse outcome). The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Changes in cortisol level in hair, during and after pregnancy
The cortisol level (pg/mg) will be determined from a hair sample as a marker of permanent stress. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Complications of pregnancy: gestational diabetes mellitus
The incidence of gestational diabetes mellitus (GDM; % of the study group) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Complications of pregnancy: gestational hypertension
The incidence of gestational hypertension (GH; % of the study group) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Complications of pregnancy: preeclampsia
The incidence of preeclampsia (PE; % of the study group) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Complications of fetal development: fetal growth restriction
The incidence of fetal growth restriction (FGR; % of the study group) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Complications of fetal development: fetal macrosomia
The incidence of fetal macrosomia (FM; % of the study group) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Childbirth parameters: type of delivery
The type of delivery (vaginal delivery, cesarean section, instrumental delivery; % of the study group) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Childbirth parameters: new-born's birth weight
The new-born's birth weight (g) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Childbirth parameters: new-born's length
The new-born's length (cm) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Childbirth parameters: APGAR score
The APGAR score (the newborn's appearance, pulse, grimace, activity, and respiration score; minimum score: 0; maximum score: 10; higher scores mean better outcome) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Childhood outcomes: changes in body weight
The changes in children's body weight (kg) will be analyzed in terms of pre- and postnatal physical activity patterns of their mothers and in relation to other selected parameters.
Childhood outcomes: changes in body height
The changes in children's body height (cm) will be analyzed in terms of pre- and postnatal physical activity patterns of their mothers and in relation to other selected parameters.
Childhood outcomes: changes in Body Mass Index
The changes in children's Body Mass Index (BMI; kg/m2) will be analyzed in terms of pre- and postnatal physical activity patterns of their mothers and in relation to other selected parameters.
Childhood outcomes: changes in systolic blood pressure
The changes in systolic blood pressure (SBP; mm Hg) in children will be analyzed in terms of pre- and postnatal physical activity patterns of their mothers and in relation to other selected parameters.
Childhood outcomes: changes in diastolic blood pressure
The changes in diastolic blood pressure (DBP; mm Hg) in children will be analyzed in terms of pre- and postnatal physical activity patterns of their mothers and in relation to other selected parameters.

Secondary Outcome Measures

Changes in maternal carbon dioxide production, during and after pregnancy
Changes from the baseline carbon dioxide production (VCO2; ml/min) in a progressive maximal exercise test on a cycloergometer with electronically regulated load, using stationary respiratory gas analyzer. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters.
Changes in maternal minute ventilation, during and after pregnancy
Changes from the baseline maternal minute ventilation (VE; l/min), including the maximal minute ventilation (VEmax) values in a progressive maximal exercise test on a cycloergometer with electronically regulated load, using stationary respiratory gas analyzer. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters.
Changes in maternal respiratory rate, during and after pregnancy
Changes from the baseline maternal respiratory rate (RR; breaths per min) in a progressive maximal exercise test on a cycloergometer with electronically regulated load, using stationary respiratory gas analyzer. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters.
Changes in maternal exercise capacity, expressed in administered load, during and after pregnancy
Changes in administered load (W) in a progressive maximal exercise test on a cycloergometer with electronically regulated load. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters.
Changes in total cholesterol, during and after pregnancy
Changes in total cholesterol (TC; mg/dl) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially related to metabolism and changing with regular exercise in the perinatal period.
Changes in low-density lipoproteins, during and after pregnancy
Changes in low-density lipoproteins (LDL; mg/dl) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially related to metabolism and changing with regular exercise in the perinatal period.
Changes in insulin concentration, during and after pregnancy
To assess the changes in insulin concentration (ng/ml), the samples will be taken on the day of the maximal exercise capacity test before the test (at fasting condition), immediately (approx. 1 min) after completion the test and approx. 40 min. after the test. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially related to metabolism and changing with regular exercise in the perinatal period.
Changes in irisin concentration, during and after pregnancy
To assess the changes in irisin concentration (ng/ml); the samples will be taken on the day of the maximal exercise capacity test before the test (at fasting condition), immediately (approx. 1 min) after completion the test and approx. 40 min. after the test. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially related to metabolism and changing with regular exercise in the perinatal period.
Changes in leptin concentration, during and after pregnancy
To assess the changes in leptin concentration (ng/ml); the samples will be taken on the day of the maximal exercise capacity test before the test (at fasting condition), immediately (approx. 1 min) after completion the test and approx. 40 min. after the test. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameter, potentially related to metabolism and changing with regular exercise in the perinatal period.
Changes in adiponectin concentration, during and after pregnancy
To assess the changes in adiponectin concentration (ng/ml); the samples will be taken on the day of the maximal exercise capacity test before the test (at fasting condition), immediately (approx. 1 min) after completion the test and approx. 40 min. after the test. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameter, potentially related to metabolism and changing with regular exercise in the perinatal period.
Changes in albumin, during and after pregnancy
To assess the changes in albumin levels (mg/l), the study participants will collect urine samples to standard urine containers on the day of the maximal exercise capacity test before the test (at fasting condition), immediately after completion the test (up to 15 min) and approx. 60 min after the test. The serum albumin levels will be also determined. The investigators will analyze changes in this parameter in terms of intervention mode and its relationship with other selected parameters, potentially related to renal function and changing with regular exercise in the perinatal period.
Changes in sodium, during and after pregnancy
To assess the changes in sodium levels (mmol/l), the study participants will collect urine samples to standard urine containers on the day of the maximal exercise capacity test before the test (at fasting condition), immediately after completion the test (up to 15 min) and approx. 60 min after the test. The serum sodium levels will be also determined. The investigators will analyze changes in this parameter in terms of intervention mode and its relationship with other selected parameters, potentially related to renal function and changing with regular exercise in the perinatal period.
Changes in potassium, during and after pregnancy
To assess the changes in potassium levels (mmol/l), the study participants will collect urine samples to standard urine containers on the day of the maximal exercise capacity test before the test (at fasting condition), immediately after completion the test (up to 15 min) and approx. 60 min after the test. The serum sodium levels will be also determined. The investigators will analyze changes in this parameter in terms of intervention mode and its relationship with other selected parameters, potentially related to renal function and changing with regular exercise in the perinatal period.
Changes in maternal amount of body fat, during and after pregnancy
Changes in maternal amount of body fat (%) will be assessed using the electrical bioimpedance method. The investigators will analyze changes in this parameter in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Changes in maternal lean body mass, during and after pregnancy
Changes in maternal lean body mass (%) will be assessed using the electrical bioimpedance method. The investigators will analyze changes in this parameter in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Changes in maternal skeletal muscle mass, during and after pregnancy
Changes in maternal skeletal muscle mass (%) will be assessed using the electrical bioimpedance method. The investigators will analyze changes in this parameters in terms of intervention mode and its relationship with other selected parameter, potentially changing with regular exercise in the perinatal period.
Changes in maternal body water, during and after pregnancy
Changes in maternal skeletal body water (%) will be assessed using the electrical bioimpedance method. The investigators will analyze changes in this parameter in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Changes in the technique of voluntary pelvic floor muscle contraction, during and after pregnancy
The technique of voluntary pelvic floor muscle contraction (Szumilewicz et al. 2019; technique scores using 1-4 scale; minimum score: 1; maximum score: 4; higher scores mean better outcome) will be evaluated using surface electromyography with a vaginal probe. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially related to pelvic floor function and changing with regular exercise in the perinatal period.
Changes in maternal neuromuscular activity of pelvic floor muscles in contractions combining pelvic floor and synergistic muscles, during and after pregnancy
The neuromuscular activity of pelvic floor muscles (µV) will be evaluated with surface electromyography with a vaginal probe, in the condition of synergistic muscle activation.The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially related to pelvic floor function and changing with regular exercise in the perinatal period.
Changes in the Oswestry Disability Index, during and after pregnancy
The investigators will assess the occurrence and severity of back pain and its impact of the everyday life using the scale of the Oswestry Disability Index (Fairbank and Pynsent, 2000; ODI score; minimum score: 0; maximum score: 50; higher scores mean worse outcome). This outcome will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Changes in spatiotemporal gait parameters: gait speed, during and after pregnancy
The changes in the gait speed (m/s) will be measured in walking using plantar pressure measurements platform and software. This outcome will be analyzed in terms of intervention mode and in relation to other selected parameters, potentially changing with regular exercise in the perinatal period.
Changes in spatiotemporal gait parameters: stride duration, during and after pregnancy
The changes in the stride duration (s) will be measured in walking using plantar pressure measurements platform and software. This outcome will be analyzed in terms of intervention mode and in relation to other selected parameters, potentially changing with regular exercise in the perinatal period.
Changes in spatiotemporal gait parameters: stance duration, during and after pregnancy
The changes in the stance duration (s) will be measured in walking using plantar pressure measurements platform and software. This outcome will be analyzed in terms of intervention mode and in relation to other selected parameters, potentially changing with regular exercise in the perinatal period.
Changes in the SF-12 Physical Score, during and after pregnancy
The investigators will use the scale of Physical and Mental Health Status based on the Short Form-12 (SF-12) questionnaire (Gandek et al., 1998; PCS-12; minimum score: 24; maximum score: 57; higher scores mean better outcome). The Physical Score will be analyzed in relation to various intervention modes during the perinatal period.
Changes in the SF-12 Mental Score, during and after pregnancy
The investigators will use the scale of Physical and Mental Health Status based on the Short Form-12 (SF-12) questionnaire (Gandek et al., 1998; MCS-12; minimum score: 19; maximum score: 61; higher scores mean better outcome). The Mental Score will be analyzed in relation to various intervention modes during the perinatal period.
Changes in the Flourishing Scale score, during and after pregnancy
The investigators will use The Flourishing Scale (Diener et al., 2009; SF score; minimum score: 8; maximum score: 56; higher scores mean better outcome) to analyze the psychosocial aspects of participation in physical activity during the perinatal period.
Changes in the Fear of COVID-19 Scale score during and after pregnancy
The investigators will use The Fear of COVID-19 Scale (Ahorsu et al., 2020; FCV-19S score; minimum score: 7; maximum score: 35; higher scores mean worse outcome)) will be assessed. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Changes in the pressure pain threshold in the hand area, during and after pregnancy
The pressure pain tolerance (PPT) will be assessed using a computerized pressure algometer in the hand area. The PPT will be expressed in the value of applied pressure (kPa). The pain test will be performed before and immediately (up to 15 minutes) after the maximal exercise test on a cycloergometer. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Changes in the pressure pain threshold in the forearm area, during and after pregnancy
The pressure pain tolerance (PPT) will be assessed using a computerized pressure algometer in the forearm area. The PPT will be expressed in the value of applied pressure (kPa). The pain test will be performed before and immediately (up to 15 minutes) after the maximal exercise test on a cycloergometer. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Changes in serum cortisol level, during and after pregnancy
The investigators will analyze the changes in serum cortisol level (ng/ml) induced by the maximal exercise test and the intervention mode, and its relationship with other selected parameters, potentially related to depression, anxiety and stress levels and changing with regular exercise in the perinatal period.
Changes in serum oxytocin level, during and after pregnancy
The investigators will analyze the changes in serum oxytocin level (ng/ml) induced by the maximal exercise test and the intervention mode, and its relationship with other selected parameters, potentially related to depression, anxiety and stress levels and changing with regular exercise in the perinatal period.
Changes in serum dopamine level, during and after pregnancy
The investigators will analyze the changes in serum dopamine level (ng/ml) induced by the maximal exercise test and the intervention mode, and its relationship with other selected parameters, potentially related to depression, anxiety and stress levels and changing with regular exercise in the perinatal period.
Changes in serum adrenaline level, during and after pregnancy
The investigators will analyze the changes in serum adrenaline level (ng/ml) induced by the maximal exercise test and the intervention mode, and its relationship with other selected parameters, potentially related to depression, anxiety and stress levels and changing with regular exercise in the perinatal period.
Changes in serum serotonin level, during and after pregnancy
The investigators will analyze the changes in serum serotonin level (ng/ml) induced by the maximal exercise test and the intervention mode, and its relationship with other selected parameters, potentially related to depression, anxiety and stress levels and changing with regular exercise in the perinatal period.
Childbirth parameters: gestational age at birth
The gestational age at birth (weeks) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Childbirth parameters: length of labor
The length of labor (hours and minutes) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Childbirth parameters: induction of labor
The rate of induction of labor (% of the study group) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Childbirth parameters: episiotomy
The rate of episiotomy (% of the study group) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Childbirth parameters: perineal lacerations
The incidence of perineal lacerations (% of the study group) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Childbirth parameters: the use of anesthetics
The rate of anesthetics use (% of the study group) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Childbirth parameters: labor complications
The incidence of labor complications (% of the study group) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Childbirth parameters: neonatal intensive care unit
The incidence of neonatal intensive care unit (NICU; % of the study group) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Childhood outcomes: changes in percentage of body fat
The changes in amount of body fat in children (%) will be analyzed in terms of pre- and postnatal physical activity patterns of their mothers and in relation to other selected parameters.
Covid-19 disease
The incidence of Covid-19 disease (% of the study group) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.

Full Information

First Posted
July 12, 2021
Last Updated
November 30, 2022
Sponsor
Gdansk University of Physical Education and Sport
Collaborators
Medical University of Gdansk, University of Gdansk, Pomeranian Medical University Szczecin
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1. Study Identification

Unique Protocol Identification Number
NCT05009433
Brief Title
HIIT vs MICT During Pregnancy and Health and Birth Outcomes in Mothers and Children
Acronym
HIIT MAMA
Official Title
The Effect of Pre- and Postnatal High Intensity Interval Training and Moderate Intensity Continuous Training on Biological, Functional and Psychological Markers of Pregnancy Disorders and Non-communicable Diseases in Mothers and Offsprings
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 24, 2021 (Actual)
Primary Completion Date
March 31, 2031 (Anticipated)
Study Completion Date
August 31, 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gdansk University of Physical Education and Sport
Collaborators
Medical University of Gdansk, University of Gdansk, Pomeranian Medical University Szczecin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Regular exercise during pregnancy and postpartum leads to health benefits for mother and child. Inactivity during pregnancy and after delivery is now treated as risky behavior. Physically active pregnant women significantly less often suffer from, among others, gestational diabetes, excessive weight gain, lipids disorders, hypertension, preeclampsia, depressive symptoms, functional and structural disorders, including stress urinary incontinence, back pain or diastasis recti abdominis (DRA). Prenatal physical activity reduces the risk of premature delivery and miscarriage, fetal macrosomia, complications in labor or the risk of metabolic disorders in children. High-intensity interval training (HIIT) has become one of the most popular trends in the fitness sector. The effectiveness of HIIT on a number of health indicators has been proven in various populations but limited data are available on HIIT during pregnancy. The first hypothesis is that the HIIT, implemented during pregnancy and after childbirth, as a stronger exercise stimulus, will have a better impact on selected biological and psychological parameters of mothers, as well as on selected health parameters of their children, compared to the MICT (moderate intensity continuous training). Therefore, it promises better preventive effects on pregnancy complications and ailments as well as non-communicable diseases occurring in these populations. In the second hypothesis, it was assumed that HIIT and MICT implemented during pregnancy and after childbirth, tailored to the specific needs of the perinatal period, will not differ in the effectiveness of maintaining normal functional parameters in women, including prevention of urinary incontinence, back pain, DRA, etc. Pregnant women who apply for the study will be divided into three groups: those attending the HIIT, MICT or educational programs. During the study, the participants will be under standard obstetric care. As comparative groups, non-pregnant women will be also recruited. The investigators will collect data on selected biological, functional and psychological parameters in the study women at each trimester of pregnancy, during the puerperium and one year after childbirth. The data from the medical documentation on the course of childbirth and the assessment of the new-born, as well as the results of preventive examinations in the study women's children aged one, two, four and six years will be also analyzed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Postpartum, Childbirth, Health Status, Physical Fitness, Noncommunicable Diseases, Metabolism, Diabetes Mellitus, Gestational, Pregnancy Induced Hypertension, Body Composition, Back Pain, Pain Threshold, Biomechanics, Pelvic Floor Disorders, Urinary Incontinence, Cognitive Function, Depression, Anxiety
Keywords
Pregnant women, Prenatal care, Postpartum women, Postnatal care, Exercise, Physical activity, Exercise intervention, Educational intervention, Exercise test, High-intensity interval training, Moderate-intensity continuous training, Health Status, Physical fitness, Childbirth, Birth outcomes, Infant, Child

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study model is parallel in the two subgroups. The first subgroup consists of pregnant women who will be assigned to one of the three interventions: high intensity interval training program, moderate intensity continuous program or educational program on healthy lifestyle. The second subgroup will be age-matched nonpregnant women and they will be also assigned to the above three interventions. The pregnant women will be evaluated both in comparison to other pregnant women intervention groups and to the appropriate control non-pregnant groups.
Masking
InvestigatorOutcomes Assessor
Masking Description
Due to the trial design and specificity of the interventions it is not possible to blind the study participants in terms of the allocation to the study groups. The HIIT and MICT groups will attend exercise sessions of high or moderate intesity, 3 times a week, while the comparative groups will not be subjected to any exercise intervention. However the data collectors and assessors will be blinded to the group allocation.
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pregnant HIIT group
Arm Type
Experimental
Arm Description
The high intensity interval training (HIIT) program will be implemented according to the World Health Organization guidelines on physical activity and sedentary behavior (2020) and on the recommendations on physical activity and exercise during pregnancy and postpartum period published by the American College of Obstetricians and Gynecologists (2020). The program will be also based on the "High-Intensity Interval Training for Cardiometabolic Disease Prevention" report by American College of Sports Medicine (2019). During the study, the participant will be under standard obstetric care on her own. She is obliged to inform her obstetric care provider about participation in the HIIT program and to provide feedback to the project coordinator as to possible recommendations of the obstetric care provider regarding the exercise.
Arm Title
Pregnant MICT group
Arm Type
Active Comparator
Arm Description
The moderate intensity continuous training (MICT) program will be implemented based on the World Health Organization guidelines on physical activity and sedentary behavior (2020) and on the recommendations on physical activity and exercise during pregnancy and postpartum period published by the American College of Obstetricians and Gynecologists (2020). During the study, the participant will be under standard obstetric care on her own. She is obliged to inform her obstetric care provider about participation in the MICT program and to provide feedback to the project coordinator as to possible recommendations of the obstetric care provider regarding the exercise.
Arm Title
Pregnant standard care group
Arm Type
Sham Comparator
Arm Description
During the study, the participant will be under standard obstetric care on her own. She is obliged to inform her obstetric care provider about participation in the HIIT Mama study and to provide feedback to the project coordinator as to possible contraindications to taking part in the study tests.
Arm Title
Nonpregnant HIIT group
Arm Type
Experimental
Arm Description
The high intensity interval training (HIIT) program will be implemented according to the World Health Organization guidelines on physical activity and sedentary behavior (2020) and on the "High-Intensity Interval Training for Cardiometabolic Disease Prevention" report by American College of Sports Medicine (2019). During the study, the participant will be under standard health care on her own. She is obliged to inform her health care provider about participation in the HIIT Mama study and to provide feedback to the project coordinator as to possible contraindications to exercise or taking part in the study tests.
Arm Title
Nonpregnant MICT group
Arm Type
Active Comparator
Arm Description
The moderate intensity continuous training program will be implemented according to the World Health Organization guidelines on physical activity and sedentary behavior (2020). During the study, the participant will be under standard health care on her own. She is obliged to inform her health care provider about participation in the HIIT Mama study and to provide feedback to the project coordinator as to possible contraindications to exercise or taking part in the study tests.
Arm Title
Nonpregnant standard care group
Arm Type
Sham Comparator
Arm Description
During the study, the participant will be under standard health care on her own. She is obliged to inform her health care provider about participation in the HIIT Mama study and to provide feedback to the project coordinator as to possible contraindications to exercise or taking part in the study tests.
Intervention Type
Behavioral
Intervention Name(s)
High intensity interval training program for pregnant women
Other Intervention Name(s)
HIIT during pregnancy
Intervention Description
Pregnant women will participate in 8-week HIIT cycles until the day of delivery, 3 times a week, in a volume of each session of 60 minutes. The main part (15-20 min) will be conducted in a form of high intensity intervals, approx. 85-90% of maximum exercise capacity. The intervals will consist of performing exercises for 30-60 seconds, alternating with a 30-60 second rest break, in the ratio of exercise time to rest 1:2, 1:1 or 2:1, according to the individual possibilities of the participant and taking into account the training progression and stage of pregnancy. The exercise intensity will be monitored with the use of heart rate monitors, the Borg Rating of Perceived Exertion (RPE) and the Talk Test. After birth, women will participate in 3-month HIIT cycles from the moment of achieving postpartum readiness to training until one year postpartum. Classes will be carried out stationary or online, depending on the pandemic situation and the availability of the woman.
Intervention Type
Behavioral
Intervention Name(s)
Moderate intensity continuous training program for pregnant women
Other Intervention Name(s)
MICT during pregnancy
Intervention Description
Pregnant women will participate in 8-week MICT cycles until the day of delivery, 3 times a week, in a volume of each session of 60 minutes. The main part (20-25 min) will be conducted in a form of moderate intensity continuous exercise, of 70-80% of the maximum exercise capacity, e.g. in the form of high- and low-impact aerobics choreography with music. The sessions will also include resistance, neuromotor, body posture and flexibility exercises (25 min), breathing exercises, relaxation and visualization of pregnancy or childbirth (10 min). The exercise intensity will be monitored with the use of heart rate monitors, the Borg Rating of Perceived Exertion (RPE) and the Talk Test. After birth, women will participate in 3-month MICT cycles from the moment of achieving postpartum readiness to training until one year postpartum. Classes will be carried out stationary or online, depending on the pandemic situation and the availability of the woman.
Intervention Type
Behavioral
Intervention Name(s)
Standard obstetric care with extended education on healthy lifestyle
Intervention Description
Pregnant women will get standard obstetric care according to the national law. They will attend educational sessions on a healthy lifestyle, physical activity in the perinatal period and selected aspects of pregnancy and motherhood. Educational classes will be conducted online in real time, at least once every two weeks, until one year postpartum.
Intervention Type
Behavioral
Intervention Name(s)
High intensity interval training program for nonpregnant women
Other Intervention Name(s)
Lifetime HIIT
Intervention Description
Nonpregnant women will participate in 8-week HIIT cycles for a period of 8 months, 3 times a week, in a volume of each session of 60 minutes. The main part (15-20 min) will be conducted in a form of high intensity intervals, approx. 85-90% of maximum exercise capacity. The intervals will consist of performing exercises for 30-60 seconds, alternating with a 30-60 second rest break, in the ratio of exercise time to rest 1:2, 1:1 or 2:1, according to the individual possibilities of the participant and taking into account the training progression. The exercise intensity will be monitored with the use of heart rate monitors, the Borg Rating of Perceived Exertion (RPE) and the Talk Test. For the next 12 months of the project, women will participate in 3-month HIIT cycles. Classes will be carried out stationary or online, depending on the pandemic situation and the availability of the woman.
Intervention Type
Behavioral
Intervention Name(s)
Moderate intensity continuous training program for nonpregnant women
Other Intervention Name(s)
Lifetime MICT
Intervention Description
Nonpregnant women will participate in 8-week MICT cycles for a period of 8 months, 3 times a week, in a volume of each session of 60 minutes. The main part (20-25 min) will be conducted in a form of moderate continuous intensity exercise, of 70-80% of the maximum exercise capacity, e.g. in the form of high- and low-impact aerobics choreography with music. The sessions will also include resistance, neuromotor, body posture and flexibility exercises (25 min), breathing exercises and relaxation (10 min). The exercise intensity will be monitored with the use of heart rate monitors, the Borg Rating of Perceived Exertion (RPE) and the Talk Test. For the next 12 months of the project, women will participate in 3-month MICT cycles. Classes will be carried out stationary or online, depending on the pandemic situation and the availability of the woman.
Intervention Type
Behavioral
Intervention Name(s)
Standard health care with extended education on healthy lifestyle
Intervention Description
Nonpregnant women will get standard health care according to the national law. They will attend educational sessions on a healthy lifestyle, physical activity and selected aspects of preparation to pregnancy and motherhood. Classes will be conducted online in real time, at least once every two weeks, for a period of 20 months.
Primary Outcome Measure Information:
Title
Changes in maternal oxygen consumption, during and after pregnancy
Description
Changes from the baseline maternal oxygen consumption (VO2; ml/min), including the maximal oxygen consumption (VO2max) values in a progressive maximal exercise test on a cycloergometer with electronically regulated load, using stationary respiratory gas analyzer. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in maternal heart rate, during and after pregnancy
Description
Changes from the baseline heart rate (HR; beats per minute), including the maximal HR values, in a progressive maximal exercise test on a cycloergometer with electronically regulated load, using heart rate monitor. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in systolic blood pressure, during and after pregnancy
Description
Changes from the baseline maternal systolic blood pressure (SBP; mm Hg), in a progressive maximal exercise test on a cycloergometer with electronically regulated load, using electronic blood pressure monitor. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in diastolic blood pressure, during and after pregnancy
Description
Changes from the baseline maternal diastolic blood pressure (DBP; mm Hg), in a progressive maximal exercise test on a cycloergometer with electronically regulated load, using electronic blood pressure monitor. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in blood glucose level, during and after pregnancy
Description
To assess the changes in glucose levels (mg/dl) the blood samples will be taken on the day of the maximal exercise capacity test before the test (at fasting condition), immediately (approx. 1 min) after completion the test and approx. 40 min. after the test. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially related to metabolism and changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in triglycerides, during and after pregnancy
Description
Changes in triglycerides (TG; mg/dl) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially related to metabolism and changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in high-density lipoproteins, during and after pregnancy
Description
Changes in high-density lipoproteins (HDL; mg/dl) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially related to metabolism and changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in urea, during and after pregnancy
Description
To assess the changes in urea levels (ml/dl), the study participants will collect urine samples to standard urine containers on the day of the maximal exercise capacity test before the test (at fasting condition), immediately after completion the test (up to 15 min) and approx. 60 min after the test. The investigators will analyze changes in this parameter in terms of intervention mode and its relationship with other selected parameters, potentially related to renal function and changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in creatinine, during and after pregnancy
Description
To assess the changes in creatinine levels (ml/dl), the study participants will collect urine samples to standard urine containers on the day of the maximal exercise capacity test before the test (at fasting condition), immediately after completion the test (up to 15 min) and approx. 60 min after the test. The investigators will analyze the changes in this parameter in terms of intervention mode and its relationship with other selected parameters, potentially related to renal function and changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in maternal weight, during and after pregnancy
Description
Changes in maternal weight will be expressed in kilograms (kg). The investigators will analyze the changes in this parameter in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in maternal Body Mass Index during and after pregnancy
Description
Changes in Body Mass Index (BMI, kg/m2) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in maternal neuromuscular activity of pelvic floor muscles, during and after pregnancy
Description
The neuromuscular activity of pelvic floor muscles (µV) will be evaluated with surface electromyography with a vaginal probe, in the condition of synergistic muscle relaxation. The investigators will analyze the changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially related to pelvic floor function and changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in the Incontinence Impact Questionnaire score, during and after pregnancy
Description
The urinary incontinence symptoms will be assessed using the scale of incontinence impact on the quality of life based on the Incontinence Impact Questionnaire - short form (Uebersax et al., 1995; IIQ-7 score; minimum score: 0; maximum score: 100; higher scores mean worse outcome). The investigators will analyze the changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially related to pelvic floor function and changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in the Urogenital Distress Inventory score, during and after pregnancy
Description
The pelvic floor disorders will be assessed using the scale based on the Urogenital Distress Inventory - short form questionnaire (Uebersax et al., 1995; UDI - 6 score; minimum score: 0; maximum score: 100; higher scores mean worse outcome). The investigators will analyze the changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially related to pelvic floor function and changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in the inter-rectus distance, during and after pregnancy
Description
The changes in the inter-rectus distance (IRD, mm) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in the center of pressure excursions (static balance), during and after pregnancy
Description
The changes in the excursions of the center of pressure (COP; mm) will be measured in standing position using a specialized force platform. The changes in the static balance will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in lumbar spine mobility, during and after pregnancy
Description
The changes in the lumbar spine mobility (°) will be measured in standing position using specialized motion detectors and software. The changes lumbar spine mobility will be analyzed in terms of intervention mode and in relation to other selected parameters, potentially changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in cervical spine mobility, during and after pregnancy
Description
The changes in the cervical spine mobility (°) will be measured in sitting position using specialized motion detectors and software. The changes lumbar spine mobility will be analyzed in terms of intervention mode and in relation to other selected parameters, potentially changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in foot loading, during and after pregnancy
Description
The changes in foot loading (kPa) will be measured in standing position using plantar pressure measurements platform and software. This outcome will be analyzed in terms of intervention mode and in relation to other selected parameters, potentially changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in spatiotemporal gait parameters: step length, during and after pregnancy
Description
The changes in the step length (m) will be measured in walking using plantar pressure measurements platform and software. This outcome will be analyzed in terms of intervention mode and in relation to other selected parameters, potentially changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in spatiotemporal gait parameters: step width, during and after pregnancy
Description
The changes in the step width (m) will be measured in walking using plantar pressure measurements platform and software. This outcome will be analyzed in terms of intervention mode and in relation to other selected parameters, potentially changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in the hand grip strength, during and after pregnancy
Description
The hand muscle strength (kg) will be assessed using the electronic hand grip dynamometer. The participant will perform the test separately for the right and left hands.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in the pressure pain tolerance in the hand area, during and after pregnancy
Description
The pressure pain tolerance (PTOL) will be assessed using a computerized pressure algometer in the hand area. The PTOL will be expressed in the value of applied pressure (kPa). The pain test will be performed before and immediately (up to 15 minutes) after the maximal exercise test on a cycloergometer. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in the pressure pain tolerance in the forearm area, during and after pregnancy
Description
The pressure pain tolerance (PTOL) will be assessed using a computerized pressure algometer in the forearm area. The PTOL will be expressed in the value of applied pressure (kPa). The pain test will be performed before and immediately (up to 15 minutes) after the maximal exercise test on a cycloergometer. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in number of errors in the Stroop Interference test (version S8: congruent/incongruent), during and after pregnancy
Description
The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in reaction time based on the Stroop Interference test (version S8: congruent/incongruent), during and after pregnancy
Description
The time spent to complete each task, as well as the total time (s) to complete the Stroop Interference test will be assessed. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in the Beck Depression Inventory - II score, during and after pregnancy
Description
The occurrence and severity of depression symptoms using the scale of the Beck Depression Inventory - II (Beck et al., BDI -II score; minimum score: 0; maximum score: 63; higher scores mean worse outcome).The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in the Fear of Childbirth questionnaire scores, during and after pregnancy
Description
The fear of childbirth will be assessed using a scale based on the Fear of Childbirth scale questionnaire (Areskog et al., 1992; minimum score: 0; maximum score: 63; higher scores mean worse outcome). The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in cortisol level in hair, during and after pregnancy
Description
The cortisol level (pg/mg) will be determined from a hair sample as a marker of permanent stress. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Complications of pregnancy: gestational diabetes mellitus
Description
The incidence of gestational diabetes mellitus (GDM; % of the study group) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Time Frame
The data will be collected from the pregnant women groups before starting the intervention and after the completion of each training or educational cycle (each training or education cycle lasts 8 weeks) until childbirth.
Title
Complications of pregnancy: gestational hypertension
Description
The incidence of gestational hypertension (GH; % of the study group) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Time Frame
The data will be collected from the pregnant women groups before starting the intervention and after the completion of each training or educational cycle (each training or education cycle lasts 8 weeks) until childbirth.
Title
Complications of pregnancy: preeclampsia
Description
The incidence of preeclampsia (PE; % of the study group) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Time Frame
The data will be collected from the pregnant women groups before starting the intervention and after the completion of each training or educational cycle (each training or education cycle lasts 8 weeks) until childbirth.
Title
Complications of fetal development: fetal growth restriction
Description
The incidence of fetal growth restriction (FGR; % of the study group) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Time Frame
The data will be collected from the pregnant women groups before starting the intervention and after the completion of each training or educational cycle (each training or education cycle lasts 8 weeks) until childbirth.
Title
Complications of fetal development: fetal macrosomia
Description
The incidence of fetal macrosomia (FM; % of the study group) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Time Frame
The data will be collected from the pregnant women groups before starting the intervention and after the completion of each training or educational cycle (each training or education cycle lasts 8 weeks) until childbirth.
Title
Childbirth parameters: type of delivery
Description
The type of delivery (vaginal delivery, cesarean section, instrumental delivery; % of the study group) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Time Frame
The data will be collected from the pregnant women groups in the first two months after their childbirth.
Title
Childbirth parameters: new-born's birth weight
Description
The new-born's birth weight (g) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Time Frame
The data will be collected from the pregnant women groups in the first two months after their childbirth.
Title
Childbirth parameters: new-born's length
Description
The new-born's length (cm) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Time Frame
The data will be collected from the pregnant women groups in the first two months after their childbirth.
Title
Childbirth parameters: APGAR score
Description
The APGAR score (the newborn's appearance, pulse, grimace, activity, and respiration score; minimum score: 0; maximum score: 10; higher scores mean better outcome) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Time Frame
The data will be collected from the pregnant women groups in the first two months after their childbirth.
Title
Childhood outcomes: changes in body weight
Description
The changes in children's body weight (kg) will be analyzed in terms of pre- and postnatal physical activity patterns of their mothers and in relation to other selected parameters.
Time Frame
The data will be collected from the offsprings at one, two, four and six years of age.
Title
Childhood outcomes: changes in body height
Description
The changes in children's body height (cm) will be analyzed in terms of pre- and postnatal physical activity patterns of their mothers and in relation to other selected parameters.
Time Frame
The data will be collected from the offsprings at one, two, four and six years of age.
Title
Childhood outcomes: changes in Body Mass Index
Description
The changes in children's Body Mass Index (BMI; kg/m2) will be analyzed in terms of pre- and postnatal physical activity patterns of their mothers and in relation to other selected parameters.
Time Frame
The data will be collected from the offsprings at one, two, four and six years of age.
Title
Childhood outcomes: changes in systolic blood pressure
Description
The changes in systolic blood pressure (SBP; mm Hg) in children will be analyzed in terms of pre- and postnatal physical activity patterns of their mothers and in relation to other selected parameters.
Time Frame
The data will be collected from the offsprings at one, two, four and six years of age.
Title
Childhood outcomes: changes in diastolic blood pressure
Description
The changes in diastolic blood pressure (DBP; mm Hg) in children will be analyzed in terms of pre- and postnatal physical activity patterns of their mothers and in relation to other selected parameters.
Time Frame
The data will be collected from the offsprings at one, two, four and six years of age.
Secondary Outcome Measure Information:
Title
Changes in maternal carbon dioxide production, during and after pregnancy
Description
Changes from the baseline carbon dioxide production (VCO2; ml/min) in a progressive maximal exercise test on a cycloergometer with electronically regulated load, using stationary respiratory gas analyzer. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in maternal minute ventilation, during and after pregnancy
Description
Changes from the baseline maternal minute ventilation (VE; l/min), including the maximal minute ventilation (VEmax) values in a progressive maximal exercise test on a cycloergometer with electronically regulated load, using stationary respiratory gas analyzer. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in maternal respiratory rate, during and after pregnancy
Description
Changes from the baseline maternal respiratory rate (RR; breaths per min) in a progressive maximal exercise test on a cycloergometer with electronically regulated load, using stationary respiratory gas analyzer. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in maternal exercise capacity, expressed in administered load, during and after pregnancy
Description
Changes in administered load (W) in a progressive maximal exercise test on a cycloergometer with electronically regulated load. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in total cholesterol, during and after pregnancy
Description
Changes in total cholesterol (TC; mg/dl) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially related to metabolism and changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in low-density lipoproteins, during and after pregnancy
Description
Changes in low-density lipoproteins (LDL; mg/dl) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially related to metabolism and changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in insulin concentration, during and after pregnancy
Description
To assess the changes in insulin concentration (ng/ml), the samples will be taken on the day of the maximal exercise capacity test before the test (at fasting condition), immediately (approx. 1 min) after completion the test and approx. 40 min. after the test. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially related to metabolism and changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in irisin concentration, during and after pregnancy
Description
To assess the changes in irisin concentration (ng/ml); the samples will be taken on the day of the maximal exercise capacity test before the test (at fasting condition), immediately (approx. 1 min) after completion the test and approx. 40 min. after the test. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially related to metabolism and changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in leptin concentration, during and after pregnancy
Description
To assess the changes in leptin concentration (ng/ml); the samples will be taken on the day of the maximal exercise capacity test before the test (at fasting condition), immediately (approx. 1 min) after completion the test and approx. 40 min. after the test. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameter, potentially related to metabolism and changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in adiponectin concentration, during and after pregnancy
Description
To assess the changes in adiponectin concentration (ng/ml); the samples will be taken on the day of the maximal exercise capacity test before the test (at fasting condition), immediately (approx. 1 min) after completion the test and approx. 40 min. after the test. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameter, potentially related to metabolism and changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in albumin, during and after pregnancy
Description
To assess the changes in albumin levels (mg/l), the study participants will collect urine samples to standard urine containers on the day of the maximal exercise capacity test before the test (at fasting condition), immediately after completion the test (up to 15 min) and approx. 60 min after the test. The serum albumin levels will be also determined. The investigators will analyze changes in this parameter in terms of intervention mode and its relationship with other selected parameters, potentially related to renal function and changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in sodium, during and after pregnancy
Description
To assess the changes in sodium levels (mmol/l), the study participants will collect urine samples to standard urine containers on the day of the maximal exercise capacity test before the test (at fasting condition), immediately after completion the test (up to 15 min) and approx. 60 min after the test. The serum sodium levels will be also determined. The investigators will analyze changes in this parameter in terms of intervention mode and its relationship with other selected parameters, potentially related to renal function and changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in potassium, during and after pregnancy
Description
To assess the changes in potassium levels (mmol/l), the study participants will collect urine samples to standard urine containers on the day of the maximal exercise capacity test before the test (at fasting condition), immediately after completion the test (up to 15 min) and approx. 60 min after the test. The serum sodium levels will be also determined. The investigators will analyze changes in this parameter in terms of intervention mode and its relationship with other selected parameters, potentially related to renal function and changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in maternal amount of body fat, during and after pregnancy
Description
Changes in maternal amount of body fat (%) will be assessed using the electrical bioimpedance method. The investigators will analyze changes in this parameter in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in maternal lean body mass, during and after pregnancy
Description
Changes in maternal lean body mass (%) will be assessed using the electrical bioimpedance method. The investigators will analyze changes in this parameter in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in maternal skeletal muscle mass, during and after pregnancy
Description
Changes in maternal skeletal muscle mass (%) will be assessed using the electrical bioimpedance method. The investigators will analyze changes in this parameters in terms of intervention mode and its relationship with other selected parameter, potentially changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in maternal body water, during and after pregnancy
Description
Changes in maternal skeletal body water (%) will be assessed using the electrical bioimpedance method. The investigators will analyze changes in this parameter in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in the technique of voluntary pelvic floor muscle contraction, during and after pregnancy
Description
The technique of voluntary pelvic floor muscle contraction (Szumilewicz et al. 2019; technique scores using 1-4 scale; minimum score: 1; maximum score: 4; higher scores mean better outcome) will be evaluated using surface electromyography with a vaginal probe. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially related to pelvic floor function and changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in maternal neuromuscular activity of pelvic floor muscles in contractions combining pelvic floor and synergistic muscles, during and after pregnancy
Description
The neuromuscular activity of pelvic floor muscles (µV) will be evaluated with surface electromyography with a vaginal probe, in the condition of synergistic muscle activation.The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially related to pelvic floor function and changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in the Oswestry Disability Index, during and after pregnancy
Description
The investigators will assess the occurrence and severity of back pain and its impact of the everyday life using the scale of the Oswestry Disability Index (Fairbank and Pynsent, 2000; ODI score; minimum score: 0; maximum score: 50; higher scores mean worse outcome). This outcome will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in spatiotemporal gait parameters: gait speed, during and after pregnancy
Description
The changes in the gait speed (m/s) will be measured in walking using plantar pressure measurements platform and software. This outcome will be analyzed in terms of intervention mode and in relation to other selected parameters, potentially changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in spatiotemporal gait parameters: stride duration, during and after pregnancy
Description
The changes in the stride duration (s) will be measured in walking using plantar pressure measurements platform and software. This outcome will be analyzed in terms of intervention mode and in relation to other selected parameters, potentially changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in spatiotemporal gait parameters: stance duration, during and after pregnancy
Description
The changes in the stance duration (s) will be measured in walking using plantar pressure measurements platform and software. This outcome will be analyzed in terms of intervention mode and in relation to other selected parameters, potentially changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in the SF-12 Physical Score, during and after pregnancy
Description
The investigators will use the scale of Physical and Mental Health Status based on the Short Form-12 (SF-12) questionnaire (Gandek et al., 1998; PCS-12; minimum score: 24; maximum score: 57; higher scores mean better outcome). The Physical Score will be analyzed in relation to various intervention modes during the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in the SF-12 Mental Score, during and after pregnancy
Description
The investigators will use the scale of Physical and Mental Health Status based on the Short Form-12 (SF-12) questionnaire (Gandek et al., 1998; MCS-12; minimum score: 19; maximum score: 61; higher scores mean better outcome). The Mental Score will be analyzed in relation to various intervention modes during the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in the Flourishing Scale score, during and after pregnancy
Description
The investigators will use The Flourishing Scale (Diener et al., 2009; SF score; minimum score: 8; maximum score: 56; higher scores mean better outcome) to analyze the psychosocial aspects of participation in physical activity during the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in the Fear of COVID-19 Scale score during and after pregnancy
Description
The investigators will use The Fear of COVID-19 Scale (Ahorsu et al., 2020; FCV-19S score; minimum score: 7; maximum score: 35; higher scores mean worse outcome)) will be assessed. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in the pressure pain threshold in the hand area, during and after pregnancy
Description
The pressure pain tolerance (PPT) will be assessed using a computerized pressure algometer in the hand area. The PPT will be expressed in the value of applied pressure (kPa). The pain test will be performed before and immediately (up to 15 minutes) after the maximal exercise test on a cycloergometer. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in the pressure pain threshold in the forearm area, during and after pregnancy
Description
The pressure pain tolerance (PPT) will be assessed using a computerized pressure algometer in the forearm area. The PPT will be expressed in the value of applied pressure (kPa). The pain test will be performed before and immediately (up to 15 minutes) after the maximal exercise test on a cycloergometer. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in serum cortisol level, during and after pregnancy
Description
The investigators will analyze the changes in serum cortisol level (ng/ml) induced by the maximal exercise test and the intervention mode, and its relationship with other selected parameters, potentially related to depression, anxiety and stress levels and changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in serum oxytocin level, during and after pregnancy
Description
The investigators will analyze the changes in serum oxytocin level (ng/ml) induced by the maximal exercise test and the intervention mode, and its relationship with other selected parameters, potentially related to depression, anxiety and stress levels and changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in serum dopamine level, during and after pregnancy
Description
The investigators will analyze the changes in serum dopamine level (ng/ml) induced by the maximal exercise test and the intervention mode, and its relationship with other selected parameters, potentially related to depression, anxiety and stress levels and changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in serum adrenaline level, during and after pregnancy
Description
The investigators will analyze the changes in serum adrenaline level (ng/ml) induced by the maximal exercise test and the intervention mode, and its relationship with other selected parameters, potentially related to depression, anxiety and stress levels and changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Changes in serum serotonin level, during and after pregnancy
Description
The investigators will analyze the changes in serum serotonin level (ng/ml) induced by the maximal exercise test and the intervention mode, and its relationship with other selected parameters, potentially related to depression, anxiety and stress levels and changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Childbirth parameters: gestational age at birth
Description
The gestational age at birth (weeks) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Time Frame
The data will be collected from the pregnant women groups in the first two months after their childbirth.
Title
Childbirth parameters: length of labor
Description
The length of labor (hours and minutes) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Time Frame
The data will be collected from the pregnant women groups in the first two months after their childbirth.
Title
Childbirth parameters: induction of labor
Description
The rate of induction of labor (% of the study group) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Time Frame
The data will be collected from the pregnant women groups in the first two months after their childbirth.
Title
Childbirth parameters: episiotomy
Description
The rate of episiotomy (% of the study group) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Time Frame
The data will be collected from the pregnant women groups in the first two months after their childbirth.
Title
Childbirth parameters: perineal lacerations
Description
The incidence of perineal lacerations (% of the study group) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Time Frame
The data will be collected from the pregnant women groups in the first two months after their childbirth.
Title
Childbirth parameters: the use of anesthetics
Description
The rate of anesthetics use (% of the study group) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Time Frame
The data will be collected from the pregnant women groups in the first two months after their childbirth.
Title
Childbirth parameters: labor complications
Description
The incidence of labor complications (% of the study group) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Time Frame
The data will be collected from the pregnant women groups in the first two months after their childbirth.
Title
Childbirth parameters: neonatal intensive care unit
Description
The incidence of neonatal intensive care unit (NICU; % of the study group) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Time Frame
The data will be collected from the pregnant women groups in the first two months after their childbirth.
Title
Childhood outcomes: changes in percentage of body fat
Description
The changes in amount of body fat in children (%) will be analyzed in terms of pre- and postnatal physical activity patterns of their mothers and in relation to other selected parameters.
Time Frame
The data will be collected from the offsprings at one, two, four and six years of age.
Title
Covid-19 disease
Description
The incidence of Covid-19 disease (% of the study group) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Other Pre-specified Outcome Measures:
Title
The level of physical activity based on the International Physical Activity Questionnaire
Description
The investigators will use the International Physical Activity Questionnaire to calculate IPAQ score (minimum score: 0; maximum score: not specified; higher scores mean better outcome) to determine the participants' levels of physical activity prior to enrollment in the study and during the study.
Time Frame
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Title
Ten Item Personality Inventory score
Description
The investigators will use the Ten Item Personality Inventory (Gosling et al., 2003; TIPI scores; minimum score: 2; maximum score: 14; the higher the score, the greater the intensity of the personality traits) to analyze the psychosocial determinants of participation in physical activity during the perinatal period.
Time Frame
Before starting the intervention.
Title
Life Orientation Test - Revised score
Description
The investigators will use the optimism versus pessimism scale based on the Life Orientation Test - Revised (Scheier et al., 1994; LOT-R score; minimum score: 6; maximum score: 24; the higher the score, the higher level of optimism) to analyze the psychosocial determinants of participation in physical activity during the perinatal period.
Time Frame
Before starting the intervention.
Title
The Fat mass and obesity-associated (FTO) gene polymorphism
Description
The Fat mass and obesity-associated (FTO) gene polymorphism will be analyzed as a determinant of the incidence of metabolic disorders during pregnancy and postpartum, in relation to different patterns of physical activity and other selected parameters.
Time Frame
Before starting the intervention.
Title
The Mu-Opioid Receptor Genetic Polymorphism (OPRM1)
Description
The Mu-Opioid Receptor Genetic Polymorphism (OPRM1) will be analyzed as a determinant of pain perception during pregnancy, labor and postpartum, in relation to different patterns of physical activity and other selected parameters.
Time Frame
Before starting the intervention.
Title
The serotonin transporter (5-HTTLPR) polymorphism
Description
The serotonin transporter (5-HTTLPR) polymorphism will be analyzed as a determinant of depressive symptoms and anxiety during pregnancy and postpartum, in relation to different patterns of physical activity and other selected parameters.
Time Frame
Before starting the intervention.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Criteria: Inclusion Criteria: For pregnant women: course of pregnancy allowing participation in physical activities adapted to pregnant women consent of the obstetric care provider to participate in the study tests and exercise classes; taking part in all diagnostic and control tests to assess selected biological, functional and psychological parameters at each trimester of pregnancy, during the puerperium and one year after childbirth; participant's consent to use data from the medical documentation on the course of childbirth and the assessment of the new-born, as well as the results of preventive examinations in children aged one, two, four and six, routinely performed according to the Polish pediatric care system; availability to participate in classes three times a week until the day of delivery; declaration of participation in postpartum classes at least once a week and self-completion of the exercise program according to written instructions prepared by the exercise specialist; women can participate in the exercise programs regardless of their level of fitness or exercise capacity, as well as the level of motor skills (based on the diagnostic exercise tests, the exercise program will be tailored to the individual needs and capabilities of a woman). For nonpregnant women: nulliparous; lack of diagnosed infertility and other disorders of the reproductive system; taking part in all diagnostic and control tests to assess selected biological, functional and psychological parameters at indicated time points: before and after each of the 8-week exercise program during the first 8 months of the study and once every 3 months during the following twelve months of the study declaration of availability to participate in exercise classes three times a week for the first 8 months of the program (attendance at least 80% is required); declaration of participation in classes at least once a week and self-completion of the exercise program to the required 150 minutes of physical activity per week, according to the written guidelines prepared by the instructor, for the next 12 months of the program; women can participate in the exercise program regardless of their level of fitness or exercise capacity, as well as the level of motor skills (based on the diagnostic exercise tests, the exercise program will be tailored to the individual needs and capabilities of a woman). Exclusion Criteria for Pregnant and Nonpregnant Women: contraindications to increased physical effort or to any of the diagnostic or control tests; allergies to materials used during diagnostic and control tests (e.g. nickel present in steel plates of vaginal electrodes, disinfectants); other conditions that, according to the researchers, will threaten the health or safety of the participants or will significantly affect the quality of the collected data.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna N Szumilewicz, Assoc. Prof.
Phone
601880207
Ext
+48
Email
anna.szumilewicz@awf.gda.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Żaneta Wojdakowska
Phone
58 55 47 101
Ext
+48
Email
nauka@awf.gda.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna N Szumilewicz, Assoc. Prof.
Organizational Affiliation
Gdansk University of Physical Activity and Sport
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratory of Physical Effort and Genetics in Sport at Gdansk University of Physical Education and Sport
City
Gdańsk
State/Province
Pomorskie
ZIP/Postal Code
80-336
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna N Szumilewicz, Assoc. Prof.
Phone
601880207
Ext
+48
Email
anna.szumilewicz@awf.gda.pl
First Name & Middle Initial & Last Name & Degree
Robert Urbański, PhD
Phone
58 554 74 15
Ext
+48
Email
lab.sport@awf.gda.pl

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD that underlie results reported in publications will be available to other researchers. All procedures will be conducted in accordance with the Regulation (2016/679) of the European Parliament and of the Council of 27 April 2016 on the protection of individuals with regard to the processing of personal data and on the free movement of such data and repealing Directive 95/46 / EC. Each data set will be linked to a given research task description, the methods used to generate the data, the period of time data were collected and whether the data have been updated. The data will be stored in the standard file formats, such as MS Excel (.xlsx), MS Word (.docx), Comma Separated Values (.csv), Portable Document Format (.pdf), Joint Photographic Experts Group (.jpg), Tagged Image File Format (.tiff). Transformation of the high-resolution images may be necessary prior to data sharing. No further manipulation of these files is necessary.
IPD Sharing Time Frame
The data will become available 6 months after publication, for a period of 10 years.
IPD Sharing Access Criteria
All data published in peer-reviewed scientific journals will be made available to all interested researchers and preserved long-term. Data will be made available via open-access repository following the acceptance of the scientific journal, publishing the study reports. The process for gaining access to non-publicly accessible data will be straightforward and involve email communication to the Principal Investigator. We expect no embargo periods for political/commercial/patent or publishing process reasons. The URL for the data repository will be shared as soon as it is ready.
Citations:
PubMed Identifier
27127296
Citation
Bo K, Artal R, Barakat R, Brown W, Davies GA, Dooley M, Evenson KR, Haakstad LA, Henriksson-Larsen K, Kayser B, Kinnunen TI, Mottola MF, Nygaard I, van Poppel M, Stuge B, Khan KM. Exercise and pregnancy in recreational and elite athletes: 2016 evidence summary from the IOC expert group meeting, Lausanne. Part 1-exercise in women planning pregnancy and those who are pregnant. Br J Sports Med. 2016 May;50(10):571-89. doi: 10.1136/bjsports-2016-096218. No abstract available.
Results Reference
background
PubMed Identifier
27733352
Citation
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HIIT vs MICT During Pregnancy and Health and Birth Outcomes in Mothers and Children

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