Diabetes, GestationalNCT02931656
Acute Effects of an Aquatic Physical Exercise on Glycemic Control of Gestational Diabetes
A study testing Aquatic exercise in people with Diabetes, Gestational, run by Professor Fernando Figueira Integral Medicine Institute at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Diabetes, Gestational
- What is being tested?
- Aquatic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2016to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Kidney disease or collagenosis;
- Previous history of gestational diabetes;
- Diabetes type 1 or type 2;
- Hypertensive disorders related to pregnancy;
- Hemodynamic instability;
- Obstetric labor;
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- 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;
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Diabetes, Gestational
- Being tested
- Aquatic exercise
- Keywords
- Gestational Diabetes
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquatic exerciseOther
Also called Water aerobics, Hydrotherapy
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.
| Study group | Role | What they receive |
|---|---|---|
| GDM aquatic exercise | Experimental | GDM Diagnosis criteria accordance with to IADPSG / WHO Receives: Other: Aquatic exercise |
| Control Group aquatic exercise | Active comparator | No change in blood glucose levels Group, investigated between 24-28 weeks of gestation. Receives: Other: Aquatic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Glycemic level
Blood glucose test: maternal glucose levels
Measured: Before and up to 5 minutes after the intervention
Secondary outcomes (5)
Change from Systolic and diastolic blood pressure
Measured in mmHg every medical consultation
Measured: Before and up to 5 minutes after the intervention
Change from Heart rate (pulse)
number of beats in 60 seconds
Measured: Before and up to 5 minutes after the intervention
Change from Respiratory rate
number of movements indicative of inspiration and expiration per 60 seconds
Measured: Before and up to 5 minutes after the intervention
Change from Oxygen saturation
Quantity oxygen is being transported in the blood at the time of measurement
Measured: Before and up to 5 minutes after the intervention
Change from Fetal heart rate
Heartbeat frequency of the fetus per minute
Measured: Before and up to 5 minutes after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2018
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes, GestationalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Professor Fernando Figueira Integral Medicine Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Ciência e Tecnologia de Pernambuco, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, José Roberto da Silva Junior, Professor Fernando Figueira Integral Medicine Institute
- Investigators
- João Guilherme Bezerra Alves/, Doctor, Study director, Institute of Integrative Medicine Professor Fernando FigueiraAlex Sandro Rolland de Souza, Doctor, Study chair, Institute of Integrative Medicine Professor Fernando Figueira
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02931656
- Sponsor's protocol ID
- 1111-1188-1100
- Status last verified
- Oct 2019
- First submitted
- 28 Sep 2016
- Last updated
- 9 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of an Aquatic Physical Exercise on Glycemic Control of Gestational Diabetes
- ClinicalTrials.gov ID
- NCT02931656
- Acronym / sponsor ID
- 1111-1188-1100
- Conditions
- Diabetes, Gestational
- Keywords
- Gestational Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Professor Fernando Figueira Integral Medicine InstituteUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Ciência e Tecnologia de Pernambuco, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Mar 2016
- Primary completion
- Dec 2018 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 13 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GDM aquatic exercise | Experimental | Other: Aquatic exerciseGDM Diagnosis criteria accordance with to IADPSG / WHO |
| Control Group aquatic exercise | Active comparator | Other: Aquatic exerciseNo change in blood glucose levels Group, investigated between 24-28 weeks of gestation. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- Kidney disease or collagenosis;
- Previous history of gestational diabetes;
- Diabetes type 1 or type 2;
- Hypertensive disorders related to pregnancy;
- Hemodynamic instability;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aquatic exerciseAlso: Water aerobics, HydrotherapyThe 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. | Other | Control Group aquatic exercise, GDM aquatic exercise |
Primary outcome
Change from Glycemic level
Time frame: Before and up to 5 minutes after the intervention
Blood glucose test: maternal glucose levels
5 secondary outcomes
Change from Systolic and diastolic blood pressure
Time frame: Before and up to 5 minutes after the intervention
Change from Heart rate (pulse)
Time frame: Before and up to 5 minutes after the intervention
Change from Respiratory rate
Time frame: Before and up to 5 minutes after the intervention
Change from Oxygen saturation
Time frame: Before and up to 5 minutes after the intervention
Change from Fetal heart rate
Time frame: Before and up to 5 minutes after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
João Guilherme Bezerra Alves/, Doctor study director
Institute of Integrative Medicine Professor Fernando Figueira
Alex Sandro Rolland de Souza, Doctor study chair
Institute of Integrative Medicine Professor Fernando Figueira
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquatic exercise in people with Diabetes, Gestational, run by Professor Fernando Figueira Integral Medicine Institute at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Glycemic level (time frame: Before and up to 5 minutes after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2019.