Aerobic Exercise in Women With Gestational Diabetes (GDM-FIT)

University of Verona

Status: Unknown

Conditions: Gestational Diabetes Mellitus in Pregnancy

Treatments: Other: Aerobic exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT03067662

2152

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Singleton pregnancy,
• Gestational diabetes diagnosis between 18th and 28th week of gestation,
• Caucasian.

Exclusion criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Supervised exercise intervention

Experimental group

Description:

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).

Treatment:

Other: Aerobic exercise

Current standard of care

No Intervention group

Description:

Women in the control group will receive standard physical exercise recommendations.