Exercise Rehabilitation for Functional Impairment in Maintenance Hemodialysis Patients

NCT ID: NCT07303179

Last Updated: 2025-12-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2026-12-31

Brief 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.

Conditions

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

Keywords

Exercise Rehabilitation; Maintenance Hemodialysis; Physical Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Exercise Rehabilitation Therapy (ERT)

Intervention Type: BEHAVIORAL

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.

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Exercise Rehabilitation Therapy; Exercise Training Program

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First People's Hospital of Yunnan

OTHER

Sponsor Role: lead

Responsible Party

Qinyuan Deng

Resident Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The First People's Hospital of Yunnan Province

Kunming, Yunnan, China

Countries

China

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

KFKT-1023-005

Identifier Type: -

Identifier Source: org_study_id