Back to resultsInterval Versus Continuous Exercise During Pregnancy
Primary Purpose
Pregnancy Related, Glucose, Low Blood, Fetal Heart Rate or Rhythm Abnormality Affecting Fetus
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
High intensity Interval Training
Moderate Intensity Continuous Training
Sponsored by
About this trial
This is an interventional basic science trial for Pregnancy Related
Eligibility Criteria
Inclusion Criteria:
- Carrying a singleton pregnancy (i.e. greater than or equal to 20 weeks of gestation).
- Has access to a stationary bike
- Located within Canada and/or within Edmonton Alberta
Exclusion Criteria:
- History of smoking within the last year
- Taking medications that may interfere with cardiovascular function.
- High-order pregnancies, e.g. twins or above.
- Females with absolute contraindications (as outlined by the Canadian Guidelines for Physical Activity throughout Pregnancy and the PARMed-X questionnaire)
Sites / Locations
- University of Alberta
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1st Exercise session
2nd Exercise session
Arm Description
Participants completed either the HIIT or MICT session.
Participants completed the subsequent exercise protocol (i.e. HIIT or MICT)
Outcomes
Primary Outcome Measures
Flash Glucose Monitor; interstitial Glucose
Measured by a Flash Glucose monitor inserted onto the back of the left tricep
Fetal Heart Rate
Measured via ultrasound pre and post exercise
Fetal Umbilical Blood Flow
Measured Via ultrasound pre and post exercise
Secondary Outcome Measures
Maternal Heart Rate
Measured via heart rate monitor; Measured prior to, during, and after exercise.
Accelerometer
The investigators will objectively measure physical activity using an accelerometer for one week. Average number of minutes per day spent in various activity levels will be determined.
Food Log
The investigators will objectively measure nutrients in diet using a seven day food record. This is completed through Food Prodigy/ Food Processor software.
Perceived rating of perceived exertion
Borg Scale; Ratings from 6 - 20; Rating of six is minimal perceived exertion and rating of 20 is maximal perceived exertion.
Cardiovascular fitness
Graded exercise test to volitional fatigue.
Cerebral Blood Flow of Posterior cerebral artery
Measured using a trans cranial doppler ultrasound. Measured prior to, during, and after exercise.
Sleep Quality
The investigators will objectively measure sleep quality using an accelerometer for one week. Average number of hours of sleep per night, time spent awake after sleep onset, and number of awakenings will be determined
Rating of Perceived Enjoyment (1-10 Scale)
Rating of 1 is the lowest level of perceived enjoyment, rating of 10 is maximal perceived enjoyment
Blood pressure
Measured with a finometer; Measured prior to, during, and after exercise.
Cardiac Output
Measured with a finometer; Measured prior to, during, and after exercise.
Cerebral blood flow of middle cerebral artery
Measured using a trans cranial doppler ultrasound. Measured prior to, during, and after exercise.
fasted blood sample- sex hormones
Fasted blood samples (~30ml) will be analyzed for sex hormones (estrogen, progesterone, testosterone).
Physical Activity Questionnaire
The participants will report physical activity using the pregnancy physical activity questionnaire (gives metabolic equivalent hours per week (MET-hr/week).
Depression rating
Participants will answer a 10-question questionnaire regarding their mood. A score of 10 or higher is indicative of depressive symptoms. The investigators will report the over number of women in each group who have a score of 10+ at the start and end of the intervention.
Respiratory measures - respiratory frequency
Breathing frequency (breaths per minute). Measured using spirometry.
Respiratory measures - tidal volume
Tidal Volume (Liters per breath). Measured using spirometry.
Respiratory measures - oxygen
Oxygen metabolism (% oxygen used per breath). Measured using a gas analyzer.
Respiratory measures - carbon dioxide
Carbon Dioxide production (% carbon dioxide per breath). Measured using a gas analyzer.
Respiratory measures - lung volume
Total Lung Capacity (Liters). Measured using spirometry.
Fetal Outcome - birth weight
Participants will provide the investigators with birth weight for the infant (grams)
fetal outcomes- length
Participants will provide the investigators with birth length for the infant (cm)
fetal outcomes- gestational age
Participants will provide the investigators with gestational age at delivery (weeks)
maternal outcomes- mode of delivery
Participants will provide the investigators with mode of delivery (vaginal or cesarean).
maternal outcomes- delivery complications
Participants will provide the investigators with information regarding any delivery complications.
maternal outcomes- pregnancy complications
Participants will provide the investigators with information regarding any pregnancy complications (gestational diabetes, pregnancy induced hypertension, preeclampsia).
fetal outcomes- NICU
Participants will provide the investigators with information regarding length (days) of admission to Neonatal Intensive Care Unit (NICU) if applicable
maternal outcomes- gestational weight gain
Participants will provide the investigators with the last maternal weight immediately before delivery. This will be used to calculate gestational weight gain (kg; last maternal weight - self reported pre-pregnancy weight).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05369247
Brief Title
Interval Versus Continuous Exercise During Pregnancy
Official Title
Effects of Acute High-intensity Intervals Versus Moderate-intensity Continuous Cycling on Maternal and Fetal Health
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
December 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
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
The objective of this randomized cross-over design was to investigate the fetal well-being and maternal glycemic response to an acute bout of aerobic high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT) with pregnant individuals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Related, Glucose, Low Blood, Fetal Heart Rate or Rhythm Abnormality Affecting Fetus, Fetal Blood Flow
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1st Exercise session
Arm Type
Experimental
Arm Description
Participants completed either the HIIT or MICT session.
Arm Title
2nd Exercise session
Arm Type
Experimental
Arm Description
Participants completed the subsequent exercise protocol (i.e. HIIT or MICT)
Intervention Type
Other
Intervention Name(s)
High intensity Interval Training
Intervention Description
HIIT protocol consisted of 10 one-minute intervals of high-intensity work (i.e., > 90% HRmax) interspersed with nine one-minute intervals of self-paced active recovery (19-minutes total).
Intervention Type
Other
Intervention Name(s)
Moderate Intensity Continuous Training
Intervention Description
The MICT protocol consisted of 30-minutes of moderate intensity cycling (i.e., 64 - 76% HRmax).
Primary Outcome Measure Information:
Title
Flash Glucose Monitor; interstitial Glucose
Description
Measured by a Flash Glucose monitor inserted onto the back of the left tricep
Time Frame
7-days
Title
Fetal Heart Rate
Description
Measured via ultrasound pre and post exercise
Time Frame
3-minutes
Title
Fetal Umbilical Blood Flow
Description
Measured Via ultrasound pre and post exercise
Time Frame
3-minutes
Secondary Outcome Measure Information:
Title
Maternal Heart Rate
Description
Measured via heart rate monitor; Measured prior to, during, and after exercise.
Time Frame
40-minutes
Title
Accelerometer
Description
The investigators will objectively measure physical activity using an accelerometer for one week. Average number of minutes per day spent in various activity levels will be determined.
Time Frame
7-days
Title
Food Log
Description
The investigators will objectively measure nutrients in diet using a seven day food record. This is completed through Food Prodigy/ Food Processor software.
Time Frame
7-days
Title
Perceived rating of perceived exertion
Description
Borg Scale; Ratings from 6 - 20; Rating of six is minimal perceived exertion and rating of 20 is maximal perceived exertion.
Time Frame
40-minutes
Title
Cardiovascular fitness
Description
Graded exercise test to volitional fatigue.
Time Frame
20-minutes
Title
Cerebral Blood Flow of Posterior cerebral artery
Description
Measured using a trans cranial doppler ultrasound. Measured prior to, during, and after exercise.
Time Frame
40-min
Title
Sleep Quality
Description
The investigators will objectively measure sleep quality using an accelerometer for one week. Average number of hours of sleep per night, time spent awake after sleep onset, and number of awakenings will be determined
Time Frame
7-days
Title
Rating of Perceived Enjoyment (1-10 Scale)
Description
Rating of 1 is the lowest level of perceived enjoyment, rating of 10 is maximal perceived enjoyment
Time Frame
40-minutes
Title
Blood pressure
Description
Measured with a finometer; Measured prior to, during, and after exercise.
Time Frame
40-min
Title
Cardiac Output
Description
Measured with a finometer; Measured prior to, during, and after exercise.
Time Frame
40-min
Title
Cerebral blood flow of middle cerebral artery
Description
Measured using a trans cranial doppler ultrasound. Measured prior to, during, and after exercise.
Time Frame
40-minutes
Title
fasted blood sample- sex hormones
Description
Fasted blood samples (~30ml) will be analyzed for sex hormones (estrogen, progesterone, testosterone).
Time Frame
5-minutes
Title
Physical Activity Questionnaire
Description
The participants will report physical activity using the pregnancy physical activity questionnaire (gives metabolic equivalent hours per week (MET-hr/week).
Time Frame
5-minutes
Title
Depression rating
Description
Participants will answer a 10-question questionnaire regarding their mood. A score of 10 or higher is indicative of depressive symptoms. The investigators will report the over number of women in each group who have a score of 10+ at the start and end of the intervention.
Time Frame
5-minutes
Title
Respiratory measures - respiratory frequency
Description
Breathing frequency (breaths per minute). Measured using spirometry.
Time Frame
40-minutes
Title
Respiratory measures - tidal volume
Description
Tidal Volume (Liters per breath). Measured using spirometry.
Time Frame
40-minutes
Title
Respiratory measures - oxygen
Description
Oxygen metabolism (% oxygen used per breath). Measured using a gas analyzer.
Time Frame
40-minutes
Title
Respiratory measures - carbon dioxide
Description
Carbon Dioxide production (% carbon dioxide per breath). Measured using a gas analyzer.
Time Frame
40-minutes
Title
Respiratory measures - lung volume
Description
Total Lung Capacity (Liters). Measured using spirometry.
Time Frame
40-minutes
Title
Fetal Outcome - birth weight
Description
Participants will provide the investigators with birth weight for the infant (grams)
Time Frame
within one month postpartum
Title
fetal outcomes- length
Description
Participants will provide the investigators with birth length for the infant (cm)
Time Frame
within one month postpartum
Title
fetal outcomes- gestational age
Description
Participants will provide the investigators with gestational age at delivery (weeks)
Time Frame
within one month postpartum
Title
maternal outcomes- mode of delivery
Description
Participants will provide the investigators with mode of delivery (vaginal or cesarean).
Time Frame
within one month postpartum
Title
maternal outcomes- delivery complications
Description
Participants will provide the investigators with information regarding any delivery complications.
Time Frame
within one month postpartum
Title
maternal outcomes- pregnancy complications
Description
Participants will provide the investigators with information regarding any pregnancy complications (gestational diabetes, pregnancy induced hypertension, preeclampsia).
Time Frame
any time during study
Title
fetal outcomes- NICU
Description
Participants will provide the investigators with information regarding length (days) of admission to Neonatal Intensive Care Unit (NICU) if applicable
Time Frame
within one month postpartum
Title
maternal outcomes- gestational weight gain
Description
Participants will provide the investigators with the last maternal weight immediately before delivery. This will be used to calculate gestational weight gain (kg; last maternal weight - self reported pre-pregnancy weight).
Time Frame
within one month postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Carrying a singleton pregnancy (i.e. greater than or equal to 20 weeks of gestation).
Has access to a stationary bike
Located within Canada and/or within Edmonton Alberta
Exclusion Criteria:
History of smoking within the last year
Taking medications that may interfere with cardiovascular function.
High-order pregnancies, e.g. twins or above.
Females with absolute contraindications (as outlined by the Canadian Guidelines for Physical Activity throughout Pregnancy and the PARMed-X questionnaire)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margie H Davenport, PhD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2R3
Country
Canada
12. IPD Sharing Statement
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Interval Versus Continuous Exercise During Pregnancy
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