Leg vs Arm Ergometer Exercise for Gestational Diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, single-blind trial compares leg and arm ergometer exercise added to standard care in pregnant women with gestational diabetes. Eight weeks of supervised sessions, 20-30 minutes, three times weekly at moderate intensity, will measure glucose, exercise tolerance, weight, and psychological stress. Participants are 18-35 years old, in the second trimester, with singleton pregnancies and no overt diabetes or hypertension, recruited from hospitals in Lahore. The study aims to determine if leg-based aerobic exercise provides greater metabolic and psychosocial benefits than arm-based aerobic exercise during pregnancy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Jinnah Hospital
  Lahore, Punjab Province, Pakistan Recruiting

Study contacts

• Study coordinator: Umber Nawaz, PhD PT
• Email: umber.nawaz@ubas.edu.pk
• Phone: +923334888279

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.