Diabetes During PregnancyGDMNCT07554287
Effects of Leg Ergometer Versus Arm Ergometer on Blood Glucose, Exercise Tolerance, Weight, and Psychological Stress Among Gestational Diabetic Patients
A study testing Leg Ergometer and Arm Ergometer in people with Diabetes During Pregnancy and Pregnancy Complications, run by Lahore University of Biological and Applied Sciences at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Diabetes During Pregnancy, Pregnancy Complications, Pregnancy in Diabetes
- What is being tested?
- Leg Ergometer and Arm Ergometer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 sitePakistan
- Study dates
- 26 May 2026to 15 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- Blood glucose levels:
- Random capillary glucose < 200 mg/dL at screening (to exclude overt diabetes)
- Blood pressure:
- Systolic BP < 140 mmHg and Diastolic BP < 90 mmHg (no confirmed gestational hypertension).
- If BP ≥140/90 mmHg, confirm with repeat measurement 4 hours apart; exclude if persistent.
- Willingness to participate and provide written informed consent.
- Medically cleared by obstetrician to participate in moderate aerobic exercise.
Who cannot join
- 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.
- Known major fetal anomaly.
- Anemic women with Hb < 9 g/dL (excluded to prevent exercise intolerance).
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- Uncontrolled cardiovascular disease, musculoskeletal, or medical contraindications to exercise.
- Psychiatric conditions severe enough to hinder informed consent.
- Any other medical condition that, in the opinion of the obstetrician, makes participation unsafe.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Jinnah Hospital
Lahore, Punjab Province, 54000
Dr. Shazia Rafiq, PhD, PT, +923211302898, drshaziarafiqofficial@gmail.com
Rehab Azhar, MSPT
About this study
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.
Read the detailed description
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.
- Conditions
- Diabetes During Pregnancy, Pregnancy Complications, Pregnancy in Diabetes, Gestational Diabetes Mellitus (GDM), Diabetes Complication, Gestational
- Being tested
- Leg Ergometer, Arm Ergometer
- Keywords
- gestational diabetes, diabetes in pregnancy, GDM, Gestational
- Medical subject headings
- Diabetes, Gestational, Pregnancy Complications, Pregnancy in Diabetics, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leg ErgometerOther
Also called Cycle Ergometer, Ergocycle
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.
Arm ErgometerOther
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Leg Ergometer | Experimental | Leg ergometer is used to assess the blood glucose, exercise tolerance, weight, and psychological stress among gestational diabetic patients Receives: Other: Leg Ergometer |
| 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 Receives: Other: Arm Ergometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Tolerance
Exercise tolerance will be assessed using the Modified Borg Rate of Perceived Exertion (RPE) Scale (0-10)
Measured: 8 weeks
Blood Glucose
Blood glucose levels will be measured using a capillary finger-stick method with a calibrated glucometer.
Measured: 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.
Measured: 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.
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start26 May 2026
- Primary completion26 Sep 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes During PregnancyStudies of the same condition, open and under way.
- More trials run by Lahore University of Biological and Applied SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Umber Nawaz, Lahore University of Biological and Applied Sciences
- Investigators
- Shoaib Waqas, PhD. PT, Study chair, Lahore University of Biological and Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07554287
- Sponsor's protocol ID
- UBAS/ERB/26/043030
- Other IDs
- U1111-1339-5227
- Acronym
- GDM
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared after the publication of the research.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Leg Ergometer Versus Arm Ergometer on Blood Glucose, Exercise Tolerance, Weight, and Psychological Stress Among Gestational Diabetic Patients
- ClinicalTrials.gov ID
- NCT07554287
- Acronym / sponsor ID
- GDM / UBAS/ERB/26/043030
- Conditions
- Diabetes During Pregnancy, Pregnancy Complications, Pregnancy in Diabetes, Gestational Diabetes Mellitus (GDM), Diabetes Complication, Gestational
- Keywords
- gestational diabetes, diabetes in pregnancy, GDM, Gestational
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Lahore University of Biological and Applied SciencesUniversity, hospital or other
- Study start
- 26 May 2026 (actual)
- Primary completion
- 26 Sep 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 28 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Leg Ergometer | Experimental | Other: Leg ErgometerLeg ergometer is used to assess the blood glucose, exercise tolerance, weight, and psychological stress among gestational diabetic patients |
| Arm Ergometer | Active comparator | Other: Arm ErgometerArm ergometer is used to compare with leg ergometer to assess the blood glucose, exercise tolerance, weight, psychological stress among gestational diabetic patients |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
- Known major fetal anomaly.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leg ErgometerAlso: Cycle Ergometer, ErgocycleParticipants 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 | Leg Ergometer |
| Arm ErgometerAlso: Cycle Ergometer, ErgocycleParticipants 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 | Arm Ergometer |
Primary outcome
Exercise Tolerance
Time frame: 8 weeks
Exercise tolerance will be assessed using the Modified Borg Rate of Perceived Exertion (RPE) Scale (0-10)
Blood Glucose
Time frame: 8 weeks
Blood glucose levels will be measured using a capillary finger-stick method with a calibrated glucometer.
Maternal Body Weight
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.
Gestational Diabetes Stress
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: Yes. IPD will be shared after the publication of the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shoaib Waqas, PhD. PT study chair
Lahore University of Biological and Applied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leg Ergometer and Arm Ergometer in people with Diabetes During Pregnancy and Pregnancy Complications, run by Lahore University of Biological and Applied Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Umber Nawaz, PhD PT (+923334888279, umber.nawaz@ubas.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise Tolerance (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.