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

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Complications; Gestational Diabetes Mellitus (GDM); Diabetes During Pregnancy; Pregnancy in Diabetes; Gestational; Diabetes Complication
• Intervention / Treatment: Other: Leg Ergometer; Other: Arm Ergometer

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Umber Nawaz, PhD PT; Phone Number: +923334888279; Email: umber.nawaz@ubas.edu.pk
• Study Contact Backup: Name: Shoaib Waqas, PhD. PT; Phone Number: +923024552109; Email: shoaib.waqas@ubas.edu.pk

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, 54000
      • Recruiting
      • Jinnah Hospital
      • Contact: Dr. Shazia Rafiq, PhD, PT; Phone Number: +923211302898; Email: drshaziarafiqofficial@gmail.com
      • Principal Investigator: Rehab Azhar, MSPT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Leg Ergometer; Leg ergometer is used to assess the blood glucose, exercise tolerance, weight, and psychological stress among gestational diabetic patients	Other: Leg Ergometer; 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
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	Other: Arm Ergometer; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise Tolerance	Exercise tolerance will be assessed using the Modified Borg Rate of Perceived Exertion (RPE) Scale (0-10)	8 weeks
Blood Glucose	Blood glucose levels will be measured using a capillary finger-stick method with a calibrated glucometer.	8 weeks
Maternal Body Weight	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.	8 weeks
Gestational Diabetes Stress	The Gestational Diabetes Stress Scale (GDSS) is a self-reported questionnaire used to measure psychological stress specifically related to gestational diabetes.	8 Weeks

Collaborators and Investigators

• Sponsor: Lahore University of Biological and Applied Sciences
• Investigators: Study Chair: Shoaib Waqas, PhD. PT, Lahore University of Biological and Applied Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2026
• Primary Completion (Estimated): September 26, 2026
• Study Completion (Estimated): October 15, 2026

Study Registration Dates

• First Submitted: April 21, 2026
• First Submitted That Met QC Criteria: April 21, 2026
• First Posted (Actual): April 28, 2026

Study Record Updates

• Last Update Posted (Actual): June 18, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: gestational diabetes; GDM; diabetes in pregnancy; Gestational
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes, Gestational; Pregnancy Complications; Diabetes Complications; Pregnancy in Diabetics
• Other Study ID Numbers: UBAS/ERB/26/043030; U1111-1339-5227 (Registry Identifier: WHO International Clinical Trials Registry Platform (ICTRP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD will be shared after the publication of the research.
• IPD Sharing Time Frame: For 5 years
• IPD Sharing Access Criteria: Researchers, Students, Clinicians, Common People
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No