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

Sponsor
Lahore University of Biological and Applied Sciences
Study ID
NCT07554287
Status
Recruiting
Apply to this trial

Conditions

  • Diabetes Complication
  • Diabetes During Pregnancy
  • Gestational
  • Gestational Diabetes Mellitus (GDM)
  • Pregnancy Complications
  • Pregnancy in Diabetes

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 35 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.

Study Details

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.

Key Dates

First listed
Apr 28, 2026
Start date
May 26, 2026
Status verified
Apr 2026
Primary completion
Sep 26, 2026
Completion
Oct 15, 2026

Study Design

Enrollment
108 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Leg Ergometer
    Leg ergometer is used to assess the blood glucose, exercise tolerance, weight, and psychological stress among gestational diabetic patients
  • Active Comparator: Arm Ergometer
    Arm ergometer is used to compare with leg ergometer to assess the blood glucose, exercise tolerance, weight, psychological stress among gestational diabetic patients

Primary Outcome Measure

Exercise Tolerance [ Time Frame: 8 weeks ]

Central Contacts

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