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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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 w
• Другое 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 sess

Первичные конечные точки

• Exercise Tolerance [Срок оценки: 8 weeks]
• Blood Glucose [Срок оценки: 8 weeks]
• Maternal Body Weight [Срок оценки: 8 weeks]
• Gestational Diabetes Stress [Срок оценки: 8 Weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• Jinnah Hospital — Lahore

Идентификаторы

NCT: NCT07554287 · UBAS/ERB/26/043030 · U1111-1339-5227

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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