Diabetes, GestationalNCT01940003
Effects of an Aquatic Physical Exercise Program on Glycaemic Control and Perinatal Outcomes of Gestational Diabetes: Study Protocol for a Randomized Controlled Trial
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
The purpose of this study is to verify the efficacy of an aquatic physical exercise program on GDM control and adverse maternal and fetal outcomes. 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
- 72 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2016to Dec 2018
- 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 diagnosis will be based on International Association of the Diabetes in Pregnancy Study Group (IADPSG), 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;
- 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;
Show all 11Show fewer
- 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.
Brazil1 site
Instituto de Medicina Integral Prof. Fernando Figueira
Recife, Pernambuco, 50070-550
About this study
Official title: Effects of an Aquatic Physical Exercise Program on Glycemic Control and Perinatal Outcomes of Gestational Diabetes - a Randomized Clinical Trial
The purpose of this study is to verify the efficacy of an aquatic physical exercise program on GDM control and adverse maternal and fetal outcomes.
Read the detailed description
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 randomized controlled trials (RCT) assessing the effects of aquatic physical exercise on GDM control and adverse maternal and fetal outcomes.
A RCT will be conducted at Institute of Medicine Professor Fernando Figueira (IMIP), Brazil. IMIP is a reference hospital in the Northeast Brazil for mother and child care and performed about 6,000 deliveries per year. The recruitment of patients will focus on GDM women diagnosed at IMIP that referred to this center for treatment. Obstetrical staff will identify pregnant women recently diagnosed with GDM. These patients will be approached by a member of the study team and ask permission to be forwarded after an explanation of the study goals. GDM women will be considered eligible for enrollment if they fulfill all the inclusion criteria and none of the exclusion criteria. Interested patients will be invited to sign a written informed consent.
Sample size was calculated with the aim of reducing glucose levels by 20% in intervention 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 will develop an aquatic physical exercise program in a thermal pool, three times per week during two months, and 36 gestational diabetics will receive usual care from IMIP.
To ensure that similar guidelines for GDM clinical treatment are maintained for the two groups, IMIP obstetrical staff will undertake the ongoing GDM management of all trial participants for the period of the study. Participants are usually clinically evaluated at minimum every two weeks depending on GDM control, according to the IMIP guidelines for GDM. A capillary glucose test is performed in each clinical visit. It will be analyzed the mean capillary glucose profile after intervention (minimum of five determinations per woman). Insulin or oral hypoglycemic required will be compared among the two groups.
All pregnant women will wear a pedometer (Yamax Digi Walker SW-200, Tokyo, Japan) during the whole study. Pedometer readings will provide a measure of physical activity to compare both groups. All diabetics pregnant women will be recorded of their clinical history and undertake a cardiologic evaluation.
Randomization will be done according to a computed-generated allocation (www.randomized.com). Pregnant women will be assigned, in a 1:1 ratio, to exercise intervention or usual care. Blinding of the study to the randomization arm is not possible due to the nature of intervention.
Primary endpoint will be glucose levels control (glicemy test) and use of insulin (use or not insulin), secondary endpoints will be the following maternal and fetal outcomes: weight gain during pregnancy, blood pressure, preeclampsia diagnosis, intra-uterus growth restriction, preterm birth, Cesarean section, macrosomia and maternal or neonatal intensive care admission. The information will be acquired through the medical records of patients.
Maternal and fetal characteristics of the study sample will be presented by group, intervention and control in terms of mean and SD. For group comparisons of glucose levels and perinatal 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 3.1 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. In order to evaluate the criteria for discontinuation of study will be established a Committee on External Monitoring (CME).
The physical proprieties of water provide aquatic exercises as ideal for pregnant women. An aquatic physical exercise program developed with GDM 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 GDM control.
- Conditions
- Diabetes, Gestational
- Being tested
- Aquatic exercise
- Keywords
- Diabetes, Gestational, Pregnancy Outcome, Exercise, glycemic control
- Medical subject headings
- Diabetes, Gestational, Motor Activity
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 |
|---|---|---|
| Control | No intervention | Usual care of service Institute of Medicine Professor Fernando Figueira(IMIP) prenatal |
| Aquatic exercise | Experimental | Pool-based exercise classes will be completed in groups of 4 to 6 participants under the instruction of a physiotherapist. The exercise program will be conducted three times per week and each session lasting 45 minute. This will be conducted since GDM diagnosis (26-28th gestational week) to the end of the third trimester (38-39th gestational week). Thus, an average of 30 training sessions will be planned for each pregnant woman. Receives: Other: Aquatic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control
Blood glucose test: maternal glucose levels on third trimester of pregnancy and use of insulin
Use of insulin: need to use or not of insulin to control gestational diabetes mellitus. Variable nominal dichotomous yes / no.
Measured: one year
Secondary outcomes (9)
Intra-uterus growth restriction (fetal ultrasound parameters)
Intra-uterus growth restriction diagnosis will based on the following findings:
birthweight percentile < 10 for gestational age, morphological ultrasound with Doppler (assessment of umbilical blood flow).
Measured: one year
Prematurity
Preterm birth (before 37th gestational week).
Measured: one year
Newborns with macrosomia
Cesarean section Birth injury Macrosomia (birth weight > 4,000g). Nominal variable, dichotomous yes or no.
Measured: one year
Weight gain in pregnancy
Weight measured at the end of pregnancy minus pre-pregnancy weight informed by pregnant woman (cm)
Measured: one year
Maternal or neonatal intensive care admission
Nominal variable, dichotomous yes or no.
Measured: one year
Systolic and diastolic blood pressure
Measured in mmHg every medical consultation
Measured: one year
Preeclampsia diagnosis
blood hypertension (levels of systolic blood pressure ≥ 140 mmHg and / or diastolic blood pressure ≥ 90 mmHglevels of systolic blood pressure ≥ 140 mmHg and / or diastolic blood pressure ≥ 90 mmHg) associated with proteinuria
Measured: one year
Cesarean section
Nominal variable, dichotomous yes or no.
Measured: one year
Birth injury
Be will considered any kind of injury of the newborn occurred during delivery. Nominal variable, dichotomous yes or no.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2013 (estimated)
- Study startSep 2016
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Professor Fernando Figueira Integral Medicine Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Ciência e Tecnologia de Pernambuco
- Responsible party
- Principal investigator, José Roberto da Silva Junior, Professor Fernando Figueira Integral Medicine Institute
- Investigators
- José Roberto da Silva Junior, Master, Principal investigator, Institute of Medicine Professor Fernando FigueiraJoão Guilherme Bezerra Alves, doctorate, Study director, Institute of Medicine Professor Fernando FigueiraPaulo Sergio Gomes Nogueira Borges, Master, Study chair, Institute of Medicine Professor Fernando FigueiraKarine Ferreira Agra, Master, Study chair, Institute of Medicine Professor Fernando FigueiraIsabelle Eunice de Albuquerque Pontes, Master, Study chair, Institute of Medicine Professor Fernando Figueira
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01940003
- Sponsor's protocol ID
- U1111-1147-1141
- Status last verified
- Oct 2019
- First submitted
- 23 Aug 2013
- Last updated
- 9 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
da Silva JR Jr, Borges PS, Agra KF, Pontes IA, Alves JG. Effects of an aquatic physical exercise program on glycemic control and perinatal outcomes of gestational diabetes: study protocol for a randomized controlled trial. Trials. 2013 Nov 19;14:390. doi: 10.1186/1745-6215-14-390.
PubMed 24245914
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
- Effects of an Aquatic Physical Exercise Program on Glycemic Control and Perinatal Outcomes of Gestational Diabetes - a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01940003
- Acronym / sponsor ID
- U1111-1147-1141
- Conditions
- Diabetes, Gestational
- Keywords
- Diabetes, Gestational, Pregnancy Outcome, Exercise, glycemic control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Professor Fernando Figueira Integral Medicine InstituteUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Ciência e Tecnologia de Pernambuco
- Study start
- Sep 2016
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 11 Sep 2013 (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.
The purpose of this study is to verify the efficacy of an aquatic physical exercise program on GDM control and adverse maternal and fetal outcomes.
Detailed description
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 randomized controlled trials (RCT) assessing the effects of aquatic physical exercise on GDM control and adverse maternal and fetal outcomes.
A RCT will be conducted at Institute of Medicine Professor Fernando Figueira (IMIP), Brazil. IMIP is a reference hospital in the Northeast Brazil for mother and child care and performed about 6,000 deliveries per year. The recruitment of patients will focus on GDM women diagnosed at IMIP that referred to this center for treatment. Obstetrical staff will identify pregnant women recently diagnosed with GDM. These patients will be approached by a member of the study team and ask permission to be forwarded after an explanation of the study goals. GDM women will be considered eligible for enrollment if they fulfill all the inclusion criteria and none of the exclusion criteria. Interested patients will be invited to sign a written informed consent.
Sample size was calculated with the aim of reducing glucose levels by 20% in intervention 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 will develop an aquatic physical exercise program in a thermal pool, three times per week during two months, and 36 gestational diabetics will receive usual care from IMIP.
To ensure that similar guidelines for GDM clinical treatment are maintained for the two groups, IMIP obstetrical staff will undertake the ongoing GDM management of all trial participants for the period of the study. Participants are usually clinically evaluated at minimum every two weeks depending on GDM control, according to the IMIP guidelines for GDM. A capillary glucose test is performed in each clinical visit. It will be analyzed the mean capillary glucose profile after intervention (minimum of five determinations per woman). Insulin or oral hypoglycemic required will be compared among the two groups.
All pregnant women will wear a pedometer (Yamax Digi Walker SW-200, Tokyo, Japan) during the whole study. Pedometer readings will provide a measure of physical activity to compare both groups. All diabetics pregnant women will be recorded of their clinical history and undertake a cardiologic evaluation.
Randomization will be done according to a computed-generated allocation (www.randomized.com). Pregnant women will be assigned, in a 1:1 ratio, to exercise intervention or usual care. Blinding of the study to the randomization arm is not possible due to the nature of intervention.
Primary endpoint will be glucose levels control (glicemy test) and use of insulin (use or not insulin), secondary endpoints will be the following maternal and fetal outcomes: weight gain during pregnancy, blood pressure, preeclampsia diagnosis, intra-uterus growth restriction, preterm birth, Cesarean section, macrosomia and maternal or neonatal intensive care admission. The information will be acquired through the medical records of patients.
Maternal and fetal characteristics of the study sample will be presented by group, intervention and control in terms of mean and SD. For group comparisons of glucose levels and perinatal 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 3.1 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. In order to evaluate the criteria for discontinuation of study will be established a Committee on External Monitoring (CME).
The physical proprieties of water provide aquatic exercises as ideal for pregnant women. An aquatic physical exercise program developed with GDM 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 GDM control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Usual care of service Institute of Medicine Professor Fernando Figueira(IMIP) prenatal |
| Aquatic exercise | Experimental | Other: Aquatic exercisePool-based exercise classes will be completed in groups of 4 to 6 participants under the instruction of a physiotherapist. The exercise program will be conducted three times per week and each session lasting 45 minute. This will be conducted since GDM diagnosis (26-28th gestational week) to the end of the third trimester (38-39th gestational week). Thus, an average of 30 training sessions will be planned for each pregnant woman. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- GDM diagnosis will be based on International Association of the Diabetes in Pregnancy Study Group (IADPSG), 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;
- 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 | Aquatic exercise |
Primary outcome
Glycemic control
Time frame: one year
Blood glucose test: maternal glucose levels on third trimester of pregnancy and use of insulin Use of insulin: need to use or not of insulin to control gestational diabetes mellitus. Variable nominal dichotomous yes / no.
9 secondary outcomes
Intra-uterus growth restriction (fetal ultrasound parameters)
Time frame: one year
Prematurity
Time frame: one year
Newborns with macrosomia
Time frame: one year
Weight gain in pregnancy
Time frame: one year
Maternal or neonatal intensive care admission
Time frame: one year
Systolic and diastolic blood pressure
Time frame: one year
Preeclampsia diagnosis
Time frame: one year
Cesarean section
Time frame: one year
Birth injury
Time frame: one year
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.
- Derived from this study: PubMed 24245914da Silva JR Jr, Borges PS, Agra KF, Pontes IA, Alves JG. Effects of an aquatic physical exercise program on glycemic control and perinatal outcomes of gestational diabetes: study protocol for a randomized controlled trial. Trials. 2013 Nov 19;14:390. doi: 10.1186/1745-6215-14-390.
- Click here for more information about this Instiuto de Medicina Integral Prof. Fernando Figueira during the study: Effects of an aquatic physical exercise program on glycemic control and perinatal outcomes of gestational diabetesLink provided by the sponsor.
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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.
José Roberto da Silva Junior, Master principal investigator
Institute of Medicine Professor Fernando Figueira
João Guilherme Bezerra Alves, doctorate study director
Institute of Medicine Professor Fernando Figueira
Paulo Sergio Gomes Nogueira Borges, Master study chair
Institute of 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 3 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?
Glycemic control (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01940003, which also lists 1 linked publication.
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.