Exercise Rehabilitation for Functional Impairment in Maintenance Hemodialysis Patients

NCT07303179 | Active Not Recruiting

• 1 other identifier: KFKT-1023-005
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

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

  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).

  From enrollment until 2 years after the end of intervention.

• Incidence of hospitalization due to cardiovascular events

  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.

  From enrollment until 2 years after the end of intervention.

• Incidence of cerebrovascular events

  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.

  From enrollment until 2 years after the end of intervention.

• All-cause mortality

  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.

  From enrollment until 2 years after the end of intervention.

Secondary Outcomes (20)

• 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.

Other Outcomes (3)

• Correlation between metabolomic and proteomic features and 6-minute walk distance (6MWD)

  From baseline sampling to 2 years after the end of intervention.

• Correlation between metabolomic and proteomic features and depressive symptoms (Self-Rating Depression Scale, SDS)

  From baseline sampling to 2 years after the end of intervention.

• Correlation between metabolomic and proteomic features and cognitive function (Montreal Cognitive Assessment, MoCA)

  From baseline sampling to 2 years after the end of intervention.

Study Arms (2)

Exercise Rehabilitation Group

EXPERIMENTAL

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.

Behavioral: Exercise Rehabilitation Therapy (ERT)

Control Group

NO INTERVENTION

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

Interventions

Exercise Rehabilitation Therapy (ERT) 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.

Also known as: Exercise Rehabilitation Therapy, Exercise Training Program

Exercise Rehabilitation Group

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First People's Hospital of Yunnan: lead

Study Sites (1)

The First People's Hospital of Yunnan Province

Kunming, Yunnan, 650032, China

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: December 24, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)