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Effects of Leg Ergometer Versus Arm Ergometer on Blood Glucose, Exercise Tolerance, Weight, and Psychological Stress Among Gestational Diabetic Patients

RECRUITINGN/ASponsored by Lahore University of Biological and Applied Sciences
Actively Recruiting
PhaseN/A
SponsorLahore University of Biological and Applied Sciences
Started2026-05-26
Est. completion2026-09-26
Eligibility
Age18 Years – 35 Years
SexFEMALE
Healthy vol.Accepted

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

Age: 18 Years – 35 YearsSex: FEMALEHealthy volunteers accepted
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.

Conditions7

DiabetesDiabetes ComplicationDiabetes During PregnancyGestationalGestational Diabetes Mellitus (GDM)Pregnancy ComplicationsPregnancy in Diabetes

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