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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1339-5227 | Registry Identifier | WHO International Clinical Trials Registry Platform (ICTRP) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Leg Ergometer | Experimental | Leg ergometer is used to assess the blood glucose, exercise tolerance, weight, and psychological stress among gestational diabetic patients |
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| Arm Ergometer | Active Comparator | Arm ergometer is used to compare with leg ergometer to assess the blood glucose, exercise tolerance, weight, psychological stress among gestational diabetic patients |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leg Ergometer | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Exercise Tolerance | Exercise tolerance will be assessed using the Modified Borg Rate of Perceived Exertion (RPE) Scale (0-10) | 8 weeks |
| Blood Glucose | Blood glucose levels will be measured using a capillary finger-stick method with a calibrated glucometer. | 8 weeks |
| 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. | 8 weeks |
| Gestational Diabetes Stress | The Gestational Diabetes Stress Scale (GDSS) is a self-reported questionnaire used to measure psychological stress specifically related to gestational diabetes. | 8 Weeks |
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Inclusion Criteria:
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).
Women with first time GDM in pregnancy.
Women with clinical diagnosis of gestational diabetes according to hospital/WHO criteria or hospital diagnostic test.
Blood glucose levels:
Random capillary glucose < 200 mg/dL at screening (to exclude overt diabetes)
Blood pressure:
Willingness to participate and provide written informed consent.
Medically cleared by obstetrician to participate in moderate aerobic exercise.
Exclusion Criteria:
This study is open to individuals who self-identify as female and are currently pregnant. Only women diagnosed with gestational diabetes during pregnancy are eligible to participate. The study specifically focuses on pregnant women in their second trimester, as gestational diabetes is a condition that occurs during pregnancy and requires female reproductive physiology. Participants must be willing to take part in supervised exercise sessions and routine assessments. Individuals who do not identify as female or who are not pregnant are not eligible for this study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Umber Nawaz, PhD PT | Contact | +923334888279 | umber.nawaz@ubas.edu.pk | |
| Shoaib Waqas, PhD. PT | Contact | +923024552109 | shoaib.waqas@ubas.edu.pk |
| Name | Affiliation | Role |
|---|---|---|
| Shoaib Waqas, PhD. PT | Lahore University of Biological and Applied Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jinnah Hospital | Recruiting | Lahore | Punjab Province | 54000 | Pakistan |
IPD will be shared after the publication of the research.
For 5 years
Researchers, Students, Clinicians, Common People
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This study is a randomized, parallel-group interventional trial comparing leg ergometer and arm ergometer exercise in women with gestational diabetes. Participants will be randomly allocated into two groups: Group A (leg ergometer + standard care) and Group B (arm ergometer + standard care). The intervention will last 8 weeks, with sessions conducted 3 times per week for 20-30 minutes at moderate intensity (RPE 3-4). There will be no crossover, and participants will remain in their assigned groups throughout the study. Both groups will receive standard care including dietary advice, physical activity guidance, and routine antenatal care. Outcomes will be assessed at baseline and post-intervention, including blood glucose, exercise tolerance, body weight, and psychological stress. This model allows a controlled comparison of two safe and practical exercise modalities.
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| Arm Ergometer | Other | 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. |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D011248 | Pregnancy Complications |
| D011254 | Pregnancy in Diabetics |
| D048909 | Diabetes Complications |
| ID | Term |
|---|---|
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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