Aerobic Exercise in Women With Gestational Diabetes
- Conditions
- Gestational Diabetes Mellitus in Pregnancy
- Interventions
- Other: Aerobic exercise
- Registration Number
- NCT03067662
- Lead Sponsor
- Universita di Verona
- Brief Summary
A few, small randomized controlled trials have investigated the effects of exercise on blood glucose levels in women with gestational diabetes (GDM), with inconsistent results.
To assess the effects of supervised exercise in women with GDM, 48 women with gestational diabetes, diagnosed between the 18th and 28th week of gestation, will be recruited, after exclusion of subjects with contraindications to exercise. These subjects will be randomly assigned to two groups: structured exercise intervention or standard care.
Women in the intervention group will perform low intensity aerobic exercise three times per week at 30% HRR (heart rate reserve), under continuous heart rate monitoring. Duration of each session will progress from 26 minutes the first week to 40 minutes (increasing 2 min/week). Women in the control group will receive standard diet and physical exercise recommendations.
In all women, clinical, metabolic and anthropometric features will be assessed before, during and at the end of the study. Newborn data will also be collected.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 48
- Singleton pregnancy,
- Gestational diabetes diagnosis between 18th and 28th week of gestation,
- Caucasian.
- Hemodynamically significant heart disease,
- Restricted lung disease,
- Incompetent cervix/cerclage,
- Persistent second or third trimester bleeding,
- Placenta previa,
- Threatened preterm labor,
- Ruptured membranes,
- Preeclampsia,
- Hypertension,
- Severe anemia,
- Cardiac arrhythmias,
- History of epilepsy,
- Chronic bronchitis,
- Orthopedic limitations,
- Overt hyperthyroidism/ hypothyroidism,
- Type 1 diabetes mellitus,
- Drugs that interfere with metabolic control (such as cortisone)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Supervised exercise intervention Aerobic exercise Women in the intervention group will perform low intensity aerobic exercise three times per week at 30% HRR (Heart Rate Reserve), under continuous heart rate monitoring. Duration of each session will progress from 26 minutes the first week to 40 minutes (by increasing 2 min/week).
- Primary Outcome Measures
Name Time Method Change in fasting plasma glucose levels (mg/dL) Before intervention and at 35-37 week of gestation
- Secondary Outcome Measures
Name Time Method Pulse wave velocity (PWV, m/s) Before intervention and at 35-37 week of gestation A non-invasive assessment of arterial stiffness (in the carotid-radial and carotid-femoral parts of the arterial tree) by the technique of applanation tonometry
Fetus femur length (cm) At 20, 30, 34-37 week of gestation Week of delivery (wk) 3 months after delivery Change in body weight (kg) Before intervention and at 35-37 week of gestation Adiponectin levels (μg/mL) Before intervention and at 35-37 week of gestation Quality of life (questionnaire) Before intervention and at 35-37 week of gestation Measured by SF-36 (36-item Short Form Health Survey-36) questionnaire
Glucose concentration during and after exercise At 32-34 week of gestation A continuous glucose monitoring system (CGMS) will be applied at 32-34 week of gestation, and blood glucose will be recorded every 5 min over the following five days. Glucose concentrations during the 40-min exercise session, the subsequent night, and the 24-h period following exercise, as well as during the corresponding periods of a non-exercise day will be recorded, and glucose variability and time spent in hypoglycemia or hyperglycemia will be calculated
Change in caloric intake Before intervention and at 35-37 week of gestation By 3 day-food recall questionnaire (kcal/die)
Depression state (questionnaire) Before intervention and at 35-37 week of gestation Measured by Center of Epidemiological Studies Depression Scale
Fetus head circumference (cm) At 20, 30, 34-37 week of gestation Weight (kg) of child at birth 3 months after delivery Gender (M/F) 3 months after delivery Type of delivery (spontaneous, induced, caesarean section) 3 months after delivery Change in body mass index (kg/m^2, weight in kilograms, height in meters) Before intervention and at 35-37 week of gestation Change in heart rate (HR, beats per minute) Before intervention and at 35-37 week of gestation Dosage of insulin therapy, if required Before intervention and at 35-37 week of gestation Insulin units and week at start
Change in energy expenditure through voluntary physical activity Before intervention and at 35-37 week of gestation Energy expenditure is estimated by International Physical Activity Questionnaire (IPAQ)
Change in blood pressure (mmHg) Before intervention and at 35-37 week of gestation Compliance (percentage) Throughout the intervention period, an average of 3-5 months according to the gestational week of inclusion in the study Attendance at the scheduled sessions is recorded for each patient
Circulating c-reactive protein (CRP) levels (mg/dL) Before intervention and at 35-37 week of gestation Fetus bi-parietal diameter (cm) At 20, 30, 34-37 week of gestation Fetus abdominal circumference (cm) At 20, 30, 34-37 week of gestation Length (cm) of child at birth 3 months after delivery Apgar index (score) at 1st and 5th minutes Birthday Weight (kg) of child 3 months after delivery 3 months after delivery Type of feeding (breastfeeding or bottle feeding) 3 months after delivery Malformations and neonatal diseases (YES/NO) 3 months after delivery Length (cm) of child 3 months after delivery 3 months after delivery
Trial Locations
- Locations (1)
Endocrinology, Diabetes and Metabolism Section, Department of Medicine, University of Verona and Azienda Ospedaliera Universitaria Integrata of Verona
🇮🇹Verona, Italy
Endocrinology, Diabetes and Metabolism Section, Department of Medicine, University of Verona and Azienda Ospedaliera Universitaria Integrata of Verona🇮🇹Verona, ItalyPaolo MoghettiContactpaolo.moghetti@univr.it