Exercise Rehabilitation for Functional Impairment in Maintenance Hemodialysis Patients

The First People's Hospital of Yunnan Province

Status: Active, not recruiting

Conditions: Maintenance Hemodialysis (MHD); End-Stage Renal Disease (ESRD)

Treatments: Behavioral: Exercise Rehabilitation Therapy (ERT)

Study type: Interventional

Funder types: Other

Identifiers

NCT07303179

KFKT-1023-005

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. On maintenance hemodialysis for ≥3 months.
2. Age 18-74 years.
3. Receiving adequate standard medical management.
4. Hemodialysis frequency: 3 times per week.
5. Kt/V > 1.2.

Exclusion criteria

1. New York Heart Association (NYHA) class IV heart failure.
2. Recent uncontrolled unstable angina.
3. Severe peripheral arterial disease or musculoskeletal disorders.
4. Walking distance <200 meters.
5. Resting oxygen saturation <90%.
6. Amputation or other conditions precluding exercise.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Exercise Rehabilitation Group

Experimental group

Description:

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.

Treatment:

Behavioral: Exercise Rehabilitation Therapy (ERT)

Control Group

No Intervention group

Description:

Participants in this group will receive routine maintenance hemodialysis only, without any additional exercise intervention.