NCT07554287 Effects of Leg Ergometer Versus Arm Ergometer on Blood Glucose, Exercise Tolerance, Weight, and Psychological Stress Among Gestational Diabetic Patients
| NCT ID | NCT07554287 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Lahore University of Biological and Applied Sciences |
| Condition | Diabetes During Pregnancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 108 participants |
| Start Date | 2026-05-26 |
| Primary Completion | 2026-09-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 108 participants in total. It began in 2026-05-26 with a primary completion date of 2026-09-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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
Inclusion Criteria: 1. Female participants aged 18-35 years. 2. Gestational age 14-28 weeks (second trimester). 3. Singleton pregnancy (confirmed by obstetric record) only to avoid complications of multiple gestation. 4. Include both primigravida and multigravida (i.e., first or subsequent pregnancy). 5. Women with first time GDM in pregnancy. 6. Women with clinical diagnosis of gestational diabetes according to hospital/WHO criteria or hospital diagnostic test. 7. Blood glucose levels: Random capillary glucose \< 200 mg/dL at screening (to exclude overt diabetes) 8. 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. 9. Willingness to participate and provide written informed consent. 10. Medically cleared by obstetrician to participate in moderate aerobic exercise. Exclusion Criteria: 1. Previous Cesarean section or medically indicated bed rest. 2. Known pre-existing diabetes mellitus (Type 1 or Type 2 prior to pregnancy). 3. Known major obstetric complications (e.g., placenta previa, severe pre- eclampsia). 4. Patients having multiple/twin/triplet pregnancies. 5. Known major fetal anomaly. 6. Anemic women with Hb \< 9 g/dL (excluded to prevent exercise intolerance). 7. Uncontrolled cardiovascular disease, musculoskeletal, or medical contraindications to exercise. 8. Psychiatric conditions severe enough to hinder informed consent. 9. Any other medical condition that, in the opinion of the obstetrician, makes participation unsafe.
Contact & Investigator
Shoaib Waqas, PhD. PT
STUDY CHAIR
Lahore University of Biological and Applied Sciences
Frequently Asked Questions
Who can join the NCT07554287 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 35 Years, studying Diabetes During Pregnancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07554287 currently recruiting?
Yes, NCT07554287 is actively recruiting participants. Contact the research team at umber.nawaz@ubas.edu.pk for enrollment information.
Where is the NCT07554287 trial being conducted?
This trial is being conducted at Lahore, Pakistan.
Who is sponsoring the NCT07554287 clinical trial?
NCT07554287 is sponsored by Lahore University of Biological and Applied Sciences. The principal investigator is Shoaib Waqas, PhD. PT at Lahore University of Biological and Applied Sciences. The trial plans to enroll 108 participants.
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