Effects of an Aquatic Physical Exercise Program on Glycaemic Control and Perinatal Outcomes of Gestational Diabetes: Study Protocol for a Randomized Controlled Trial
1 other identifier
interventional
72
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2013
CompletedFirst Posted
Study publicly available on registry
September 11, 2013
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedOctober 9, 2019
October 1, 2019
2.2 years
August 23, 2013
October 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
one year
Secondary Outcomes (9)
Intra-uterus growth restriction (fetal ultrasound parameters)
one year
Prematurity
one year
Newborns with macrosomia
one year
Weight gain in pregnancy
one year
Maternal or neonatal intensive care admission
one year
- +4 more secondary outcomes
Study Arms (2)
Control
NO INTERVENTIONUsual care of service Institute of Medicine Professor Fernando Figueira(IMIP) prenatal
Aquatic exercise
EXPERIMENTALPool-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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto de Medicina Integral Prof. Fernando Figueira
Recife, Pernambuco, 50070-550, Brazil
Related Publications (1)
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.
PMID: 24245914DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
José Roberto da Silva Junior, Master
Institute of Medicine Professor Fernando Figueira
- STUDY DIRECTOR
João Guilherme Bezerra Alves, doctorate
Institute of Medicine Professor Fernando Figueira
- STUDY CHAIR
Paulo Sergio Gomes Nogueira Borges, Master
Institute of Medicine Professor Fernando Figueira
- STUDY CHAIR
Karine Ferreira Agra, Master
Institute of Medicine Professor Fernando Figueira
- STUDY CHAIR
Isabelle Eunice de Albuquerque Pontes, Master
Institute of Medicine Professor Fernando Figueira
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physiotherapist. Master in Maternal Health by Institute Medicine Professor Fernando Figueira. Professor of kinesiology at the College IBGM.
Study Record Dates
First Submitted
August 23, 2013
First Posted
September 11, 2013
Study Start
September 1, 2016
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
October 9, 2019
Record last verified: 2019-10