Effects of Leg Ergometer Versus Arm Ergometer on Blood Glucose, Exercise Tolerance, Weight, and Psychological Stress Among Gestational Diabetic Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Gestational Diabetes Stress Scale (GDSS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Leg Ergometer
Leg ergometer is used to assess the blood glucose, exercise tolerance, weight, and psychological stress among gestational diabetic patients
干预措施: Leg Ergometer (Other)
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
干预措施: Arm Ergometer (Other)
结局指标
主要结局
Gestational Diabetes Stress Scale (GDSS)
时间窗: 8 Weeks
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.
Exercise Tolerance
时间窗: 8 weeks
Exercise tolerance will be assessed using the Modified Borg Rate of Perceived Exertion (RPE) Scale (0-10)
Blood Glucose
时间窗: 8 weeks
Blood glucose levels will be measured using a capillary finger-stick method with a calibrated glucometer.
Maternal Body Weight
时间窗: 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.
Gestational Diabetes Stress
时间窗: 8 Weeks
The Gestational Diabetes Stress Scale (GDSS) is a self-reported questionnaire used to measure psychological stress specifically related to gestational diabetes.
次要结局
未报告次要终点
研究者
Umber Nawaz
Assistant Professor
Lahore University of Biological and Applied Sciences