Exercise Rehabilitation for Functional Impairment in Maintenance Hemodialysis Patients

A Multicenter, Randomized Controlled Study on the Evaluation of Functional Impairment and the Promotion of Exercise Rehabilitation Standards in Maintenance Hemodialysis (MHD) Patients

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.

Study Overview

• Status: Active, not recruiting
• Conditions: End-Stage Renal Disease (ESRD); Maintenance Hemodialysis (MHD)
• Intervention / Treatment: Behavioral: Exercise Rehabilitation Therapy (ERT)

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Yunnan
    • Kunming, Yunnan, China, 650032
      • The First People's Hospital of Yunnan Province

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.; Other Names: Exercise Rehabilitation Therapy; Exercise Training Program
No Intervention: Control Group; Participants in this group will receive routine maintenance hemodialysis only, without any additional exercise intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in handgrip strength	Handgrip strength will be assessed using a calibrated handgrip dynamometer. Measurements will be performed at baseline and every 6 months during the study period. The change in handgrip strength will reflect improvements in upper limb muscle strength among maintenance hemodialysis (MHD) patients receiving standardized exercise rehabilitation therapy (ERT). Unit of Measure: Kilograms (kg)	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)	Lower limb muscle strength will be assessed using the Five Times Sit-to-Stand Test (5STS). Participants will be seated on a standard armless chair (43 cm in height) with feet flat on the floor, arms crossed over the chest, and the back not supported by the chair. Upon the verbal command "start," participants will be instructed to stand up fully and sit down five times as quickly as possible. Timing will begin at the start command and stop when the participant completes the fifth stand. The time required to complete five repetitions will be recorded. Assessments will be performed at baseline and every 6 months during the study period. Changes in 5STS performance will reflect improvements in lower limb muscle function among maintenance hemodialysis patients receiving standardized exercise rehabilitation therapy (ERT). Unit of Measure: Seconds (s)	From enrollment until 2 years after the end of intervention.
Change in depressive symptoms assessed by the Self-Rating Depression Scale (SDS)	Depressive symptoms will be evaluated using the Self-Rating Depression Scale (SDS), a validated self-report instrument comprising 20 items rated on a 4-point Likert scale. The total raw score is converted to a standard score, with higher scores indicating more severe depressive symptoms. Assessments will be performed at baseline and every 6 months. Changes in SDS scores will reflect the impact of exercise rehabilitation therapy (ERT) on depression among maintenance hemodialysis (MHD) patients. Unit of Measure: Score on a scale (SDS standard score range: 25-100).	From enrollment until 2 years after the end of intervention.
Change in anxiety level assessed by the Self-Rating Anxiety Scale (SAS)	Anxiety symptoms will be assessed using the Self-Rating Anxiety Scale (SAS), a validated self-administered questionnaire consisting of 20 items. Each item is rated on a 4-point Likert scale. The total raw score is converted to a standard score, with higher scores indicating more severe anxiety symptoms. Assessments will be conducted at baseline and every 6 months during the study period. Changes in SAS scores will be used to evaluate the effect of exercise rehabilitation therapy (ERT) on anxiety levels in maintenance hemodialysis (MHD) patients. Unit of Measure: Score on a scale (SAS standard score range: 25-100).	From enrollment until 2 years after the end of intervention.
Change in body mass index (BMI)	Body mass index (BMI) will be calculated as body weight divided by the square of height (kg/m²). Measurements will be obtained at baseline and every 6 months. Changes in BMI will be used to evaluate the impact of exercise rehabilitation therapy (ERT) on body composition and nutritional status in maintenance hemodialysis (MHD) patients. Unit of Measure: Kilograms per square meter (kg/m²).	From enrollment until 2 years after the end of intervention.
Change in cognitive function assessed by the Montreal Cognitive Assessment (MoCA)	Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA) at baseline and every 6 months. The MoCA is a 30-point cognitive screening tool evaluating domains including attention, memory, language, and executive function, where higher scores indicate better cognitive performance. Changes in MoCA scores will be used to assess the effect of exercise rehabilitation therapy (ERT) on cognitive function in maintenance hemodialysis (MHD) patients. Unit of Measure: Score on a scale (MoCA score range: 0-30).	From enrollment until 2 years after the end of intervention.
Change in self-management ability assessed by the Hemodialysis Self-Management Scale	Self-management ability will be assessed using the Hemodialysis Self-Management Scale, a 20-item patient-reported questionnaire designed to evaluate self-management behaviors in patients undergoing maintenance hemodialysis. The scale assesses domains such as treatment adherence, dietary and fluid management, symptom monitoring, and health-related behaviors. Assessments will be conducted at baseline and every 6 months during the study period. Changes in self-management scores will be used to evaluate the effect of exercise rehabilitation therapy (ERT) on self-management ability in maintenance hemodialysis (MHD) patients. Unit of Measure: Score on a scale (total score; range: 0-20)	From enrollment until 2 years after the end of intervention.
Change in urea reduction ratio (URR)	Urea reduction ratio (URR) will be calculated based on pre- and post-dialysis blood urea levels at baseline and every 3 months to evaluate dialysis adequacy. Unit of Measure: Percent (%). Laboratory parameters are assessed every 3 months in accordance with routine clinical monitoring practices in maintenance hemodialysis patients.	From enrollment until 2 years after the end of intervention.
Change in single-pool Kt/V for urea	Single-pool Kt/V for urea will be calculated at baseline and every 3 months using pre- and post-dialysis blood urea concentrations to assess dialysis adequacy in maintenance hemodialysis (MHD) patients receiving exercise rehabilitation therapy (ERT). Unit of Measure: Dimensionless. Laboratory parameters are assessed every 3 months in accordance with routine clinical monitoring practices in maintenance hemodialysis patients.	From enrollment until 2 years after the end of intervention.
Change in hemoglobin concentration	Hemoglobin concentration will be measured at baseline and every 3 months to evaluate changes in anemia status in maintenance hemodialysis (MHD) patients receiving exercise rehabilitation therapy (ERT). Unit of Measure: Grams per liter (g/L). Laboratory parameters are assessed every 3 months in accordance with routine clinical monitoring practices in maintenance hemodialysis patients.	From enrollment until 2 years after the end of intervention.
Change in serum ferritin	Serum ferritin levels will be measured at baseline and every 3 months to assess changes in iron stores in MHD patients undergoing exercise rehabilitation therapy (ERT). Unit of Measure: Nanograms per milliliter (ng/mL). Laboratory parameters are assessed every 3 months in accordance with routine clinical monitoring practices in maintenance hemodialysis patients.	From enrollment until 2 years after the end of intervention.
Change in transferrin saturation (TSAT)	Transferrin saturation (TSAT) will be calculated at baseline and every 3 months to evaluate iron utilization in maintenance hemodialysis (MHD) patients receiving exercise rehabilitation therapy (ERT). Unit of Measure: Percent (%). Laboratory parameters are assessed every 3 months in accordance with routine clinical monitoring practices in maintenance hemodialysis patients.	From enrollment until 2 years after the end of intervention.
Change in serum calcium	Serum calcium levels will be measured at baseline and every 3 months to assess changes in mineral metabolism in maintenance hemodialysis (MHD) patients receiving exercise rehabilitation therapy (ERT). Unit of Measure: Millimoles per liter (mmol/L). Laboratory parameters are assessed every 3 months in accordance with routine clinical monitoring practices in maintenance hemodialysis patients.	From enrollment until 2 years after the end of intervention.
Change in serum phosphate	Serum phosphate concentrations will be measured at baseline and every 3 months to evaluate changes in mineral metabolism in maintenance hemodialysis (MHD) patients undergoing exercise rehabilitation therapy (ERT). Unit of Measure: Millimoles per liter (mmol/L). Laboratory parameters are assessed every 3 months in accordance with routine clinical monitoring practices in maintenance hemodialysis patients.	From enrollment until 2 years after the end of intervention.
Change in intact parathyroid hormone (iPTH)	Serum intact parathyroid hormone (iPTH) levels will be measured at baseline and every 3 months to assess changes in parathyroid function and mineral bone disorder status in maintenance hemodialysis (MHD) patients receiving exercise rehabilitation therapy (ERT). Unit of Measure: Picograms per milliliter (pg/mL). Laboratory parameters are assessed every 3 months in accordance with routine clinical monitoring practices in maintenance hemodialysis patients.	From enrollment until 2 years after the end of intervention.
Change in C-reactive protein (CRP)	Serum C-reactive protein (CRP) levels will be measured at baseline and every 3 months to assess changes in systemic inflammation associated with exercise rehabilitation therapy (ERT) in maintenance hemodialysis (MHD) patients. Unit of Measure: Milligrams per liter (mg/L). Laboratory parameters are assessed every 3 months in accordance with routine clinical monitoring practices in maintenance hemodialysis patients.	From enrollment until 2 years after the end of intervention.
Change in serum albumin	Serum albumin concentration will be measured at baseline and every 3 months to evaluate changes in nutritional status in maintenance hemodialysis (MHD) patients receiving exercise rehabilitation therapy (ERT). Unit of Measure: Grams per liter (g/L). Laboratory parameters are assessed every 3 months in accordance with routine clinical monitoring practices in maintenance hemodialysis patients.	From enrollment until 2 years after the end of intervention.
Change in prealbumin	Serum prealbumin levels will be assessed at baseline and every 3 months to evaluate short-term changes in nutritional status in maintenance hemodialysis (MHD) patients undergoing exercise rehabilitation therapy (ERT). Unit of Measure: Milligrams per liter (mg/L). Laboratory parameters are assessed every 3 months in accordance with routine clinical monitoring practices in maintenance hemodialysis patients.	From enrollment until 2 years after the end of intervention.
Change in triglycerides	Serum triglyceride levels will be measured at baseline and every 3 months to assess changes in lipid metabolism in maintenance hemodialysis (MHD) patients receiving exercise rehabilitation therapy (ERT). Unit of Measure: Millimoles per liter (mmol/L). Laboratory parameters are assessed every 3 months in accordance with routine clinical monitoring practices in maintenance hemodialysis patients.	From enrollment until 2 years after the end of intervention.
Change in total cholesterol	Total serum cholesterol levels will be measured at baseline and every 3 months to evaluate changes in lipid profile in maintenance hemodialysis (MHD) patients undergoing exercise rehabilitation therapy (ERT). Unit of Measure: Millimoles per liter (mmol/L). Laboratory parameters are assessed every 3 months in accordance with routine clinical monitoring practices in maintenance hemodialysis patients.	From enrollment until 2 years after the end of intervention.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between metabolomic and proteomic features and 6-minute walk distance (6MWD)	Untargeted metabolomic and proteomic profiling will be performed on blood samples collected at baseline and follow-up using liquid chromatography-mass spectrometry (LC-MS/MS). Normalized relative abundances of detected metabolites and proteins will be correlated with 6-minute walk distance (6MWD) measured by the 6-minute walk test. Correlation analyses will be conducted to identify molecular features associated with functional capacity and responsiveness to exercise rehabilitation therapy (ERT) in maintenance hemodialysis (MHD) patients. Unit of Measure: Correlation coefficient (Pearson or Spearman correlation will be used depending on data distribution).	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)	Untargeted metabolomic and proteomic profiling will be performed on blood samples collected at baseline and follow-up using LC-MS/MS. Normalized relative abundances of detected metabolites and proteins will be correlated with depressive symptom severity assessed by the Self-Rating Depression Scale (SDS). The SDS standard score ranges from 25 to 100, where higher scores indicate more severe depressive symptoms. Correlation analyses will be performed to identify molecular features associated with depressive symptoms and psychological responsiveness to ERT in MHD patients. Unit of Measure: Correlation coefficient (Pearson or Spearman correlation will be used depending on data distribution.).	From baseline sampling to 2 years after the end of intervention.
Correlation between metabolomic and proteomic features and cognitive function (Montreal Cognitive Assessment, MoCA)	Untargeted metabolomic and proteomic profiling will be performed using LC-MS/MS. Normalized molecular feature abundances will be correlated with cognitive function assessed by the Montreal Cognitive Assessment (MoCA), a 30-point cognitive screening tool, where higher scores indicate better cognitive performance. Unit of Measure: Correlation coefficient (Pearson or Spearman correlation will be used depending on data distribution).	From baseline sampling to 2 years after the end of intervention.

Collaborators and Investigators

• Sponsor: The First People's Hospital of Yunnan

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: September 25, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Actual): December 24, 2025

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Physical Function; Exercise Rehabilitation; Maintenance Hemodialysis
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Pathological Conditions, Signs and Symptoms; Kidney Failure, Chronic; Therapeutics; Physical Therapy Modalities; Patient Care; Rehabilitation; Aftercare; Continuity of Patient Care; Exercise Therapy
• Other Study ID Numbers: KFKT-1023-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No