About this trial
The current study is a single-blind, parallel-group randomized controlled trial involving 108 participants with diabetes during pregnancy. The trial will compare leg ergometer with arm ergometer. Interventions will be delivered three times per week for eight weeks. The primary outcomes are glucose, exercise tolerance, weight, and psychological stress. Assessments will be conducted at baseline and after eight weeks. The trial will be carried out at Jinnah hospital, Services hospital, Sir Ganga Ram Hospital, Lahore. The hypothesis is that the leg ergometer including aerobic exercise will result in greater reduction in glucose and exercise tolerance, weight and stress management than arm ergometer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female participants aged 18-35 years.
Gestational age 14-28 weeks (second trimester).
Singleton pregnancy (confirmed by obstetric record) only to avoid complications of multiple gestation.
Include both primigravida and multigravida (i.e., first or subsequent pregnancy).
Disqualifiers
Previous Cesarean section or medically indicated bed rest.
Known pre-existing diabetes mellitus (Type 1 or Type 2 prior to pregnancy).
Known major obstetric complications (e.g., placenta previa, severe pre- eclampsia).
Patients having multiple/twin/triplet pregnancies.
Trial design
Parallel
Treatments tested in this trial
Leg Ergometer
Other interventionParticipants in this group will perform supervised leg ergometer exercise in addition to standard care. The intervention will last for 8 weeks, with sessions conducted 3 times per week, each lasting 20-30 minutes. Exercise will be performed in a seated position using a cycle ergometer, primarily engaging lower-limb muscle groups. Intensity will be maintained at a moderate level (RPE 3-4) using the Modified Borg Scale and will be progressed gradually based on participant tolerance. Each session will include a brief warm-up and cool-down period. Standard care will include dietary counseling, general physical activity advice, and routine antenatal monitoring. Blood glucose may be checked before and after selected sessions to ensure safety and monitor response to exercise.
Arm Ergometer
Other interventionParticipants in this group will perform supervised arm ergometer exercise in addition to standard care. The intervention will last for 8 weeks, with sessions conducted 3 times per week, each lasting 20-30 minutes. Exercise will be performed in a seated position using an arm cycle ergometer, primarily engaging upper-limb muscle groups. Intensity will be maintained at a moderate level (RPE 3-4) using the Modified Borg Scale and will be progressed gradually based on participant tolerance. Each session will include a brief warm-up and cool-down period. Standard care will include dietary counseling, general physical activity advice, and routine antenatal monitoring. Blood glucose may be checked before and after selected sessions to ensure safety and monitor response to exercise.
Treatment groups
Trial outcomes
Primary outcomes
Exercise Tolerance
Exercise tolerance will be assessed using the Modified Borg Rate of Perceived Exertion (RPE) Scale (0-10)
Blood Glucose
Blood glucose levels will be measured using a capillary finger-stick method with a calibrated glucometer.
Maternal Body Weight
Maternal body weight will be measured using a calibrated digital weighing scale, placed on a flat, hard surface to ensure accuracy for monitoring gestational weight gain.
Gestational Diabetes Stress
The Gestational Diabetes Stress Scale (GDSS) is a self-reported questionnaire used to measure psychological stress specifically related to gestational diabetes.
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