A Multicenter, Randomized Controlled Study on the Evaluation of Functional Impairment and the Promotion of Exercise Rehabilitation Standards in Maintenance Hemodialysis (MHD) Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in 6-minute walk distance (6MWD)
研究概览
简要总结
Maintenance hemodialysis (MHD) is the main treatment for patients with end-stage renal disease (ESRD). Although dialysis prolongs survival, many patients experience reduced physical function, poor quality of life, and higher risks of hospitalization and death. Lack of exercise often leads to muscle weakness and disability, further burdening patients, families, and healthcare systems.
Rehabilitation medicine has shown promise in improving outcomes in patients with chronic kidney disease. Chinese experts have developed the "Standards for Rehabilitation Services in CKD Patients," which outline goals, procedures, and safety measures for exercise interventions. Based on these Standards, this study will evaluate the effects of structured exercise rehabilitation techniques (ERT) during routine dialysis.
This multicenter, randomized controlled trial will enroll 800 patients from 15 dialysis centers in China, including 40 patients at The First People's Hospital of Yunnan Province. Eligible patients will be randomly assigned to an intervention group (dialysis plus ERT) or a control group (dialysis only). ERT includes warm-up, core resistance and cycling exercises, and relaxation, performed 3 times per week for 20-60 minutes per session over 2 years.
The study will assess whether ERT can improve muscle strength, walking distance, psychological health, nutritional and cognitive status, and overall quality of life. Hospitalization and mortality will also be recorded as clinical outcomes. Results will provide scientific evidence for the feasibility, safety, and effectiveness of promoting standardized exercise rehabilitation in MHD patients.
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
- None
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •On maintenance hemodialysis for ≥3 months.
- •Age 18-74 years.
- •Receiving adequate standard medical management.
- •Hemodialysis frequency: 3 times per week.
- •Kt/V > 1.2.
排除标准
- •New York Heart Association (NYHA) class IV heart failure.
- •Recent uncontrolled unstable angina.
- •Severe peripheral arterial disease or musculoskeletal disorders.
- •Walking distance <200 meters.
- •Resting oxygen saturation <90%.
- •Amputation or other conditions precluding exercise.
研究组 & 干预措施
Exercise Rehabilitation Group
This arm will follow the "Standards for Rehabilitation Services in CKD Patients" and receive structured exercise rehabilitation therapy (ERT) in addition to routine hemodialysis. The intervention includes three phases:
Warm-up exercises (e.g., stretching, limb flexion/extension, leg raises),
Core exercises (e.g., upper-limb resistance training, bedside cycling),
Relaxation exercises (e.g., whole-body stretching).
Each session will last 20-60 minutes, three times per week, for a total duration of two years. All sessions will be supervised by trained healthcare staff, and exercise prescriptions will be individualized according to patient condition to ensure safety and feasibility.
干预措施: Exercise Rehabilitation Therapy (ERT) (Behavioral)
Control Group
Participants in this group will receive routine maintenance hemodialysis only, without any additional exercise intervention.
结局指标
主要结局
Change in 6-minute walk distance (6MWD)
时间窗: From enrollment until 2 years after the end of intervention.
Functional capacity will be assessed using the 6-minute walk test (6MWT) at baseline and every 6 months. The change in walking distance reflects improvement in functional impairment and exercise tolerance among maintenance hemodialysis (MHD) patients receiving standardized exercise rehabilitation therapy (ERT). Unit of Measure: Meters (m).
Incidence of hospitalization due to cardiovascular events
时间窗: From enrollment until 2 years after the end of intervention.
Hospitalizations caused by cardiovascular events will be recorded, including acute myocardial infarction, other acute coronary syndromes, congestive heart failure requiring hospitalization, and severe arrhythmias (e.g., complete atrioventricular block, cardiac arrest). Data will be used to assess whether ERT reduces cardiovascular morbidity. Incidence will be expressed as the proportion of participants experiencing at least one event during the follow-up period.
Incidence of cerebrovascular events
时间窗: From enrollment until 2 years after the end of intervention.
The occurrence of cerebrovascular events, including intracerebral hemorrhage, subarachnoid hemorrhage, and ischemic stroke (cardioembolic or other etiologies), will be documented and compared between the ERT and control groups. Incidence will be expressed as the proportion of participants experiencing at least one event during the follow-up period.
All-cause mortality
时间窗: From enrollment until 2 years after the end of intervention.
All-cause mortality will be monitored throughout the study to evaluate the long-term safety and prognostic impact of standardized exercise rehabilitation therapy in MHD patients. All-cause mortality will be expressed as the proportion of participants who die from any cause during the follow-up period.
次要结局
- Change in handgrip strength(From enrollment until 2 years after the end of intervention.)
- Change in lower limb muscle strength assessed by Five Times Sit-to-Stand Test (5STS)(From enrollment until 2 years after the end of intervention.)
- Change in depressive symptoms assessed by the Self-Rating Depression Scale (SDS)(From enrollment until 2 years after the end of intervention.)
- Change in anxiety level assessed by the Self-Rating Anxiety Scale (SAS)(From enrollment until 2 years after the end of intervention.)
- Change in body mass index (BMI)(From enrollment until 2 years after the end of intervention.)
- Change in cognitive function assessed by the Montreal Cognitive Assessment (MoCA)(From enrollment until 2 years after the end of intervention.)
- Change in self-management ability assessed by the Hemodialysis Self-Management Scale(From enrollment until 2 years after the end of intervention.)
- Change in urea reduction ratio (URR)(From enrollment until 2 years after the end of intervention.)
- Change in single-pool Kt/V for urea(From enrollment until 2 years after the end of intervention.)
- Change in hemoglobin concentration(From enrollment until 2 years after the end of intervention.)
- Change in serum ferritin(From enrollment until 2 years after the end of intervention.)
- Change in transferrin saturation (TSAT)(From enrollment until 2 years after the end of intervention.)
- Change in serum calcium(From enrollment until 2 years after the end of intervention.)
- Change in serum phosphate(From enrollment until 2 years after the end of intervention.)
- Change in intact parathyroid hormone (iPTH)(From enrollment until 2 years after the end of intervention.)
- Change in C-reactive protein (CRP)(From enrollment until 2 years after the end of intervention.)
- Change in serum albumin(From enrollment until 2 years after the end of intervention.)
- Change in prealbumin(From enrollment until 2 years after the end of intervention.)
- Change in triglycerides(From enrollment until 2 years after the end of intervention.)
- Change in total cholesterol(From enrollment until 2 years after the end of intervention.)
研究者
Qinyuan Deng
Resident Physician
The First People's Hospital of Yunnan