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NCT Number: NCT07554287

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

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.

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Jinnah Hospital

Lahore, Punjab Province, 54000, Pakistan

Location status: Recruiting

Location contact

Dr. Shazia Rafiq, PhD, PT

CONTACT

[email protected]

+923211302898

Rehab Azhar, MSPT

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

  • 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).
  • 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.

Treatment and study plan

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.

Other names: Cycle Ergometer, Ergocycle

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.

Other names: Cycle Ergometer, Ergocycle

Primary outcomes

  1. Exercise Tolerance

    Time frame: 8 weeks

    Exercise tolerance will be assessed using the Modified Borg Rate of Perceived Exertion (RPE) Scale (0-10)

  2. Blood Glucose

    Time frame: 8 weeks

    Blood glucose levels will be measured using a capillary finger-stick method with a calibrated glucometer.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Shoaib Waqas, PhD. PT

CONTACT

[email protected]

+923024552109

Umber Nawaz, PhD PT

CONTACT

[email protected]

+923334888279

Sponsors and collaborators

Lead sponsor

Lahore University of Biological and Applied Sciences

Other

Registry information

Acronym: GDM

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 28, 2026
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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