Effects of an aquatic physical exercise program on glycemic control and perinatal outcomes of gestational diabetes: study protocol for a randomized controlled trial.
BACKGROUND
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 for diabetic pregnant women and contributes to better glycemic control and to a decrease in 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.


METHODS
An RCT will be conducted at Instituto de Medicina Integral Prof Fernando Figueira (IMIP), Brazil. A total of 72 pregnant women will be studied; 36 gestational diabetics will undergo an aquatic physical exercise program in a thermal pool, 3 times per week over 2 months. The primary endpoint will be glucose level control and use of insulin; secondary endpoints will be the following maternal and fetal outcomes: weight gain during pregnancy, blood pressure, pre-eclampsia diagnosis, intrauterus growth restriction, preterm birth, Cesarean section, macrosomia and maternal or neonatal intensive care admission. Endpoints between intervention and control group will analyzed by t test for unpaired data and χ² test, and the level of significance will set at <0.05.


CONCLUSIONS
The physical proprieties of water make aquatic exercises ideal for pregnant women. An aquatic physical exercise program developed for GDM women will be trialed in a thermal pool and under the supervision of physiotherapist to ensure compliance. It is expected that this study will provide evidence as to the effect of aquatic physical exercise on GDM control.


BACKGROUND
ClinicalTrial.gov, NCT01940003.
José Roberto
JR
da Silva
Paulo Sérgio
PS
Borges
Karine F
KF
Agra
Isabelle Albuquerque
IA
Pontes
Mother and Child Department, Instituto de Medicina Integral Prof, Fernando Figueira (IMIP), Recife, Brazil. joaoguilherme@imip.org.br.
João Guilherme Bezerra
JG
Alves
D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism*; D001938:Brazil; D016009:Chi-Square Distribution; D002985:Clinical Protocols; D016640:Diabetes, Gestational / Q000097:blood / Q000175:diagnosis / Q000628:therapy*; D005081:Exercise Therapy / Q000379:methods*; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D007101:Immersion; D007328:Insulin / Q000627:therapeutic use; D011247:Pregnancy; D012107:Research Design; D013551:Swimming Pools; D013997:Time Factors; D016896:Treatment Outcome
D015415:Biomarkers; D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin