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

NCT07554287 | Not Yet Recruiting

• 2 other identifiers: DGRC/MSPT/26/743U1111-1339-5227
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

gestational diabetes; diabetes in pregnancy; GDM; Gestational

Outcome Measures

Primary Outcomes (4)

• Exercise Tolerance

  Exercise tolerance will be assessed using the Modified Borg Rate of Perceived Exertion (RPE) Scale (0-10) during ergometer training, which measures a participant's subjective perception of exercise intensity.

  8 weeks

• Blood Glucose

  Blood glucose levels will be measured using a capillary finger-stick method with a calibrated glucometer. * Fasting capillary blood glucose (after an overnight fast of 8-10 hours) * Random capillary blood glucose, recorded at a consistent time during clinic visits.

  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.

  8 weeks

• Gestational Diabetes Stress Scale (GDSS)

  Gestational psychological stress will be assessed using the Gestational Diabetes Stress Scale (GDSS), a condition-specific questionnaire designed to measure emotional and psychological stress related to living with gestational diabetes.

  8 Weeks

Study Arms (2)

Leg Ergometer

EXPERIMENTAL

Leg ergometer is used to assess the blood glucose, exercise tolerance, weight, and psychological stress among gestational diabetic patients

Other: Leg Ergometer

Arm Ergometer

ACTIVE COMPARATOR

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

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.

Also known as: Cycle Ergometer, Ergocycle

Leg Ergometer

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.

Also known as: Cycle Ergometer, Ergocycle

Arm Ergometer

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: This study is open to individuals who self-identify as female and are currently pregnant. Only women diagnosed with gestational diabetes during pregnancy are eligible to participate. The study specifically focuses on pregnant women in their second trimester, as gestational diabetes is a condition that occurs during pregnancy and requires female reproductive physiology. Participants must be willing to take part in supervised exercise sessions and routine assessments. Individuals who do not identify as female or who are not pregnant are not eligible for this study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lahore University of Biological and Applied Sciences: lead

Study Sites (1)

Jinnah Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Diabetes, Gestational; Pregnancy Complications; Pregnancy in Diabetics; Diabetes Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Shoaib Waqas, PhD. PT

  Lahore University of Biological and Applied Sciences

  STUDY CHAIR

Central Study Contacts

Umber Nawaz, PhD PT

CONTACT

+923334888279; umber.nawaz@ubas.edu.pk

Shoaib Waqas, PhD. PT

CONTACT

+923024552109; shoaib.waqas@ubas.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study is a randomized, parallel-group interventional trial comparing leg ergometer and arm ergometer exercise in women with gestational diabetes. Participants will be randomly allocated into two groups: Group A (leg ergometer + standard care) and Group B (arm ergometer + standard care). The intervention will last 8 weeks, with sessions conducted 3 times per week for 20-30 minutes at moderate intensity (RPE 3-4). There will be no crossover, and participants will remain in their assigned groups throughout the study. Both groups will receive standard care including dietary advice, physical activity guidance, and routine antenatal care. Outcomes will be assessed at baseline and post-intervention, including blood glucose, exercise tolerance, body weight, and psychological stress. This model allows a controlled comparison of two safe and practical exercise modalities.

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: April 28, 2026
• Study Start: April 26, 2026
• Primary Completion (Estimated): June 26, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: For 5 years
• Access Criteria: Researchers, Students, Clinicians, Common People

Locations

PA (1)