Jinnah Hospital
Lahore, Punjab Province, 54000, Pakistan
Location status: Recruiting
Location contact
Dr. Shazia Rafiq, PhD, PT
CONTACT
Rehab Azhar, MSPT
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07554287
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.
Interested in participating?
Request Info18 year–35 year
Female
Interventional
Not applicable
Lahore, Punjab Province, 54000, Pakistan
Location status: Recruiting
Dr. Shazia Rafiq, PhD, PT
CONTACT
Rehab Azhar, MSPT
PRINCIPAL_INVESTIGATOR
Gestational diabetes mellitus (GDM) is a common metabolic condition during pregnancy, characterized by glucose intolerance and increased insulin resistance. It is associated with adverse maternal and fetal outcomes, including excessive gestational weight gain, reduced exercise tolerance, and increased psychological stress. Non-pharmacological interventions, particularly structured exercise programs, are recommended as first-line management to improve glycemic control and overall maternal health.
Aerobic exercise enhances glucose uptake through skeletal muscle activity and improves insulin sensitivity. Ergometer-based exercise provides a safe, controlled, and feasible method of delivering aerobic training during pregnancy. However, there is limited evidence comparing different exercise modalities, particularly leg versus arm ergometer, in women with gestational diabetes.
This study is a randomized, parallel-group controlled trial designed to compare the effects of leg ergometer exercise and arm ergometer exercise, both combined with standard care, in women with gestational diabetes during the second trimester. A total of eligible participants will be randomly assigned into two groups. The experimental group will perform leg ergometer exercise, while the comparison group will perform arm ergometer exercise. Both interventions will be supervised, conducted three times per week for eight weeks, with each session lasting 20-30 minutes at moderate intensity (RPE 3-4).
All participants will receive standard care, including dietary advice, general physical activity guidance, and routine antenatal monitoring. The study aims to evaluate the comparative effectiveness of these two exercise modalities on blood glucose levels, exercise tolerance, body weight, and gestational psychological stress.
Outcome measures will be assessed at baseline and after completion of the intervention period. The study will be conducted in a clinical setting using standardized protocols to ensure consistency, safety, and intervention fidelity. This research aims to provide evidence for selecting appropriate, safe, and effective exercise modalities for women with gestational diabetes, particularly in resource-limited settings.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Random capillary glucose < 200 mg/dL at screening (to exclude overt diabetes)
Exclusion criteria
Participants 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.
Other names: Cycle Ergometer, Ergocycle
Participants 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.
Other names: Cycle Ergometer, Ergocycle
Time frame: 8 weeks
Exercise tolerance will be assessed using the Modified Borg Rate of Perceived Exertion (RPE) Scale (0-10)
Time frame: 8 weeks
Blood glucose levels will be measured using a capillary finger-stick method with a calibrated glucometer.
Time frame: 8 weeks
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.
Time frame: 8 Weeks
The Gestational Diabetes Stress Scale (GDSS) is a self-reported questionnaire used to measure psychological stress specifically related to gestational diabetes.
Contact information is provided by the study sponsor or research team.
Shoaib Waqas, PhD. PT
CONTACT
Umber Nawaz, PhD PT
CONTACT
Lahore University of Biological and Applied Sciences
Other
Acronym: GDM
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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