Acute Effects of an Aquatic Physical Exercise on Glycemic Control of Gestational Diabetes
Primary Purpose
Diabetes, Gestational
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Aquatic exercise
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes, Gestational focused on measuring Gestational Diabetes
Eligibility Criteria
Inclusion Criteria:
- GDM Group: GDM diagnosis will be based on International Association of the Diabetes in Pregnancy Study Group (IADPSG) and WHO, Hyperglycemia and Adverse Pregnancy Outcomes (HAPO) study (2 h 75 g oral glucose tolerance test (OGTT): a fasting glucose ≥ 92 mg/dl or a one hour result of ≥ 80 mg/dl, or a two hour result of ≥ 153 mg/dl;
- Control Group: Normal glucose tolerance (IADPSG /WHO)
- Aging 18 to 35 years;
- Physically inactive (< 150' per week based on International Physical Activity Questionnaire.
Exclusion Criteria:
- Kidney disease or collagenosis;
- Previous history of gestational diabetes;
- Diabetes type 1 or type 2;
- Hypertensive disorders related to pregnancy;
- Hemodynamic instability;
- Obstetric labor;
- Vaginal bleeding;
- Cognitive disorder, auditory, visual or motor severely limiting, attested by a medical specialist;
- Skin disorders who have a contraindication to the use of a swimming pool;
- Urinary tract infection;
- Be inserted in the program of regular exercise;
Sites / Locations
- José Roberto da Silva Junior
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
GDM aquatic exercise
Control Group aquatic exercise
Arm Description
GDM Diagnosis criteria accordance with to IADPSG / WHO
No change in blood glucose levels Group, investigated between 24-28 weeks of gestation.
Outcomes
Primary Outcome Measures
Change from Glycemic level
Blood glucose test: maternal glucose levels
Secondary Outcome Measures
Change from Systolic and diastolic blood pressure
Measured in mmHg every medical consultation
Change from Heart rate (pulse)
number of beats in 60 seconds
Change from Respiratory rate
number of movements indicative of inspiration and expiration per 60 seconds
Change from Oxygen saturation
Quantity oxygen is being transported in the blood at the time of measurement
Change from Fetal heart rate
Heartbeat frequency of the fetus per minute
Full Information
NCT ID
NCT02931656
First Posted
September 28, 2016
Last Updated
October 8, 2019
Sponsor
Professor Fernando Figueira Integral Medicine Institute
Collaborators
Fundação de Amparo à Ciência e Tecnologia do Estado de Pernambuco, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
1. Study Identification
Unique Protocol Identification Number
NCT02931656
Brief Title
Acute Effects of an Aquatic Physical Exercise on Glycemic Control of Gestational Diabetes
Official Title
Acute Effects of an Aquatic Physical Exercise on Glycemic Control of Gestational Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
June 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Professor Fernando Figueira Integral Medicine Institute
Collaborators
Fundação de Amparo à Ciência e Tecnologia do Estado de Pernambuco, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Gestational diabetes mellitus (GDM) is increasing worldwide and has been associated with adverse perinatal outcomes and high risk for chronic disease both for the mother and for the child. Physical exercise is feasible to diabetic pregnant women and contributes to a better glycemic control and to decrease adverse perinatal outcomes. However there are no studies assessing the effects of aquatic physical exercise on GDM control.
Detailed Description
The study will be conducted at Institute of Medicine Professor Fernando Figueira (IMIP), Brazil. The patients will be included in the study by consent after an explanation of the study goals. Women will be considered eligible for enrollment if they fulfill all the inclusion criteria and none of the exclusion criteria. Sample size was calculated with the aim of reducing glucose levels by 20% in intervention GDM group. A power of 80% and a level of significance of 5% was accepted and the calculated sample size in each arm was 30 patients. Assuming a drop out of 20%, 72 pregnant women will be included in the study. 36 gestational diabetics and and 36 normoglycemic pregnant women will develop an aquatic physical exercise in a thermal pool, 45 minutes per one time, from rehabilitation center of the IMIP. Before to practice the aquatic exercise women will have their physical capacity assessed by the Six minutes walk test and fetal conditions will be assessed by ultrasound. They will also be submitted to a dermatological examination by specialist. Primary endpoint will be glucose levels (glycemic test), secondary endpoints will be the following maternal and fetal: blood pressure, heart rate, respiratory rate, oxygen saturation level, fetal cardio beat and fetal movement.The variables will be measured before and after the water exercise session. Maternal and fetal characteristics of the study sample will be presented by group, intervention and control in terms of mean and standard deviation. For group comparisons of glucose levels and maternal and fetal variables, continuous and nominal data will be analyzed by t test for unpaired data and χ2 tests, respectively. Data will be analyzed using the intention-to-treat principle. Statistical analysis will be performed with the STATA version 12.0 and the level of significance will set to <0.05. Even in cases where there is the appearance of some criterion for discontinuation during the intervention (Aquatic physical exercise), the patient will be considered part of the group which was initially included in the randomization (intent to treat) and is not excluded from the study. The physical proprieties of water provide aquatic exercises as ideal for pregnant women. An aquatic physical exercise program developed with pregnant women in a thermal pool and under a physiotherapist supervision must ensure compliance. It is expected that this study provide evidences to the real role of aquatic physical exercise on glycemic control of GDM.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Gestational
Keywords
Gestational Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GDM aquatic exercise
Arm Type
Experimental
Arm Description
GDM Diagnosis criteria accordance with to IADPSG / WHO
Arm Title
Control Group aquatic exercise
Arm Type
Active Comparator
Arm Description
No change in blood glucose levels Group, investigated between 24-28 weeks of gestation.
Intervention Type
Other
Intervention Name(s)
Aquatic exercise
Other Intervention Name(s)
Water aerobics, Hydrotherapy
Intervention Description
The aquatic exercise program will be under the professional guidance of a physiotherapist, with water at a temperature of around 26 to 28°C. The exercise sessions will be executed following the steps: 1) Heating (stretching and flexibility, static method, during 5'); 2) Aerobic exercise (running, displacements and combined movements of arms and legs, with 1minute interval, to 1minute activity and of during 20') 3) Spot exercises (strength / endurance of the upper and lower limbs and abdomen, using the resistance of water for 15') 4) Relaxation (slow walks for 5'). During the sessions of exercises the pregnant women will have heart rate monitored by the frequency meter (Polar Electro OY) to control the intensity of the exercises that will focus on the range of moderate intensity.
Primary Outcome Measure Information:
Title
Change from Glycemic level
Description
Blood glucose test: maternal glucose levels
Time Frame
Before and up to 5 minutes after the intervention
Secondary Outcome Measure Information:
Title
Change from Systolic and diastolic blood pressure
Description
Measured in mmHg every medical consultation
Time Frame
Before and up to 5 minutes after the intervention
Title
Change from Heart rate (pulse)
Description
number of beats in 60 seconds
Time Frame
Before and up to 5 minutes after the intervention
Title
Change from Respiratory rate
Description
number of movements indicative of inspiration and expiration per 60 seconds
Time Frame
Before and up to 5 minutes after the intervention
Title
Change from Oxygen saturation
Description
Quantity oxygen is being transported in the blood at the time of measurement
Time Frame
Before and up to 5 minutes after the intervention
Title
Change from Fetal heart rate
Description
Heartbeat frequency of the fetus per minute
Time Frame
Before and up to 5 minutes after the intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
GDM Group: GDM diagnosis will be based on International Association of the Diabetes in Pregnancy Study Group (IADPSG) and WHO, Hyperglycemia and Adverse Pregnancy Outcomes (HAPO) study (2 h 75 g oral glucose tolerance test (OGTT): a fasting glucose ≥ 92 mg/dl or a one hour result of ≥ 80 mg/dl, or a two hour result of ≥ 153 mg/dl;
Control Group: Normal glucose tolerance (IADPSG /WHO)
Aging 18 to 35 years;
Physically inactive (< 150' per week based on International Physical Activity Questionnaire.
Exclusion Criteria:
Kidney disease or collagenosis;
Previous history of gestational diabetes;
Diabetes type 1 or type 2;
Hypertensive disorders related to pregnancy;
Hemodynamic instability;
Obstetric labor;
Vaginal bleeding;
Cognitive disorder, auditory, visual or motor severely limiting, attested by a medical specialist;
Skin disorders who have a contraindication to the use of a swimming pool;
Urinary tract infection;
Be inserted in the program of regular exercise;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
João Guilherme Bezerra Alves/, Doctor
Organizational Affiliation
Institute of Integrative Medicine Professor Fernando Figueira
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alex Sandro Rolland de Souza, Doctor
Organizational Affiliation
Institute of Integrative Medicine Professor Fernando Figueira
Official's Role
Study Chair
Facility Information:
Facility Name
José Roberto da Silva Junior
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50070-550
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Acute Effects of an Aquatic Physical Exercise on Glycemic Control of Gestational Diabetes
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