Physical Exercise in Hemodialysis Patients in End Stage Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 312
- 试验地点
- 1
- 主要终点
- Incidence of intradialytic intolerance and hemodynamic instability
研究概览
简要总结
The goal of this clinical trial is to learn whether different types of exercise performed during hemodialysis are safe, well tolerated, and beneficial for adults receiving maintenance hemodialysis. The main questions it aims to answer are:
- Are aerobic exercise using a cycle ergometer and resistance exercise using elastic bands well tolerated during hemodialysis?
- Do these exercise programs improve physical function, body composition, quality of life, and dialysis-related outcomes compared with standard care?
Researchers will compare aerobic exercise, resistance exercise, and standard hemodialysis care to evaluate differences in tolerance and health outcomes.
Participants will:
- Be assigned to one of three groups: cycle ergometer exercise, elastic-band resistance exercise, or standard care.
- Attend hemodialysis sessions as scheduled.
- Complete physical performance and body composition assessments at baseline and after 6 months.
- Complete questionnaires about health and quality of life.
The results of this study may help identify effective exercise strategies to improve health and well-being in people receiving long-term hemodialysis treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Receiving maintenance hemodialysis for more than 3 months.
- •Clinically stable condition.
- •Ability and willingness to provide written informed consent.
排除标准
- •Unstable angina.
- •Uncontrolled hypertension.
- •Any medical condition judged by the treating nephrologist to contraindicate or make intradialytic exercise unsafe
研究组 & 干预措施
Cycle ergometer
Participants performed supervised intradialytic aerobic exercise using a cycle ergometer during the first 2 hours of hemodialysis sessions. Exercise was conducted three times per week for a total of 150 minutes per week at moderate intensity, corresponding to a Borg Rating of Perceived Exertion of 12-13. Training sessions were supervised by qualified exercise professionals and monitored by dialysis nurses to ensure safety and adherence.
干预措施: Intradialytic aerobic exercise using a cycle ergometer (Behavioral)
Elastic band resistance training
Participants performed supervised intradialytic resistance exercise using progressive color-coded elastic bands during the first 2 hours of hemodialysis sessions. Training was conducted three times per week for a total of 150 minutes per week at moderate intensity and targeted both upper and lower limbs. Resistance was progressively adjusted according to individual tolerance and correct exercise execution. Sessions were supervised by exercise professionals and monitored by dialysis nurses.
干预措施: Intradialytic elastic-band resistance exercise (Behavioral)
Control
Participants received standard hemodialysis care and continued their usual activities during dialysis sessions without participation in a structured intradialytic exercise program. Clinical assessments and follow-up evaluations were performed according to the study protocol.
结局指标
主要结局
Incidence of intradialytic intolerance and hemodynamic instability
时间窗: Baseline to 6 months
Exercise tolerability will be evaluated through the incidence of intradialytic intolerance events and the maintenance of hemodynamic stability during hemodialysis sessions. Hemodynamic monitoring will include systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate measured before, during, and after exercise sessions. Clinical signs and symptoms of exercise intolerance, including hypotension, dizziness, muscle cramps, nausea, premature interruption of exercise, or other adverse events occurring during dialysis, will be recorded. Outcomes will be compared among cycle ergometer exercise, elastic-band resistance training, and combined exercise programs to assess the relative tolerability and safety of each intervention.
次要结局
- Maximal workload during cycle ergometer stress testing(Baseline to 6 months)
- Six-minute walk test distance(Baseline and 6 months)
- Step-test performance(Baseline and 6 months)
- Chair-stand test performance(Baseline and 6 months)
- Handgrip strength(Baseline and 6 months)
- Blood flow rate(Baseline and 6 months)
- Weekly exercise time(Throughout the 6-month intervention period)
- Fat-free mass and fat mass(Baseline to 6 months)
- Bone mineral content(Baseline and 6 months)
- Bone mineral status (T-score)(Baseline and 6 months)
- Appendicular skeletal muscle mass index (ASMMI)(Baseline and 6 months)
- Anthropometric circumferences(Baseline and 6 months)
- Health-related quality of life(Baseline to 6 months)
- Medication burden(Baseline to 6 months)
- Dialysis adequacy(Baseline to 6 months)
- Dialysis session duration(Baseline and 6 months)