Exercise Rehabilitation for Functional Impairment in Maintenance Hemodialysis Patients

Condition(s) studied

Investigational drug(s) / intervention(s)

Exercise Rehabilitation Therapy (ERT): The intervention follows the "Standards for Rehabilitation Services in CKD Patients" and applies structured exercise rehabilitation therapy (ERT) in addition to routine maintenance hemodialysis. The ERT program 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 of two years.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Change in 6-minute walk distance (6MWD) — 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 — 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 — 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 — 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.

Trial sites (1)

More The First People's Hospital of Yunnan trials in China

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