A Multicenter, Randomized Controlled Study on the Evaluation of Functional Impairment and the Promotion of Exercise Rehabilitation Standards in Maintenance Hemodialysis (MHD) Patients
Phase: NA
Conditions: End-Stage Renal Disease (ESRD), Maintenance Hemodialysis (MHD)
Sponsor: The First People's Hospital of Yunnan

Project Number: KFKT-1023-005                               Version: V1.0  Date: January 10, 2025 
 
Project Source and Registration Number：A Multicenter, Randomized Controlled 
Study on the Evaluation of Functional Impairment and the Promotion of 
Exercise Rehabilitation Standards in Maintenance Hemodialysis (MHD) 
Patients KFKT-1023-005 
 
A Multicenter, Randomized Controlled Study on the 
Evaluation of Functional Impairment and the 
Promotion of Exercise Rehabilitation Standards in 
Maintenance Hemodialysis (MHD) Patients 
 
Project Title：A Multicenter, Randomized Controlled Study on the Evaluation of 
Functional Impairment and the Promotion of Exercise Rehabilitation Standards in 
Maintenance Hemodialysis (MHD) Patients 
Sponsoring Institution：  The First People’s Hospital of Yunnan Province  
Department：  Department of Nephrology  
Study Duration：  January 2024 – December 2026  
Version Number：V1.0 
Version Date：         2025.01.10          
 
 
 
 
 
 
 

 
2 
I. Study Introduction 
Maintenance hemodialysis (MHD) is the primary renal replacement therapy for 
patients with end-stage renal disease (ESRD). The therapeutic goal has gradually 
shifted from simply prolonging survival to improving quality of life. However, MHD 
patients commonly exhibit impaired physical function, with a reduction of more than 
50% in physical activity compared to the general population. Prolonged bed rest or 
lack of exercise leads to muscle weakness, functional impairment, reduced quality of 
life, and significantly increased hospitalization and mortality rates. This not only 
imposes a heavy economic and caregiving burden on families but also places 
enormous pressure on healthcare resources. How to improve physical function, 
reduce complications, and enhance quality of life in MHD patients has become a 
major focus in nephrology research worldwide. 
In recent years, the application of rehabilitation medicine in nephrology has gained 
increasing attention. Based on available evidence, Chinese experts have proposed the 
“Standards for Rehabilitation Services in Chronic Kidney Disease Patients” 
(hereinafter referred to as “the Standards”), which define the core objectives, 
technical procedures, and safety requirements for exercise rehabilitation in MHD 
patients. The Standards emphasize that scientific rehabilitation interventions can 
improve functional impairment, enhance overall health, and reduce hospitalization 
and mortality. Building on these Standards, this study will employ a multicenter, 
randomized controlled trial (RCT) to verify the clinical effectiveness of 
implementing the Standards in improving functional impairment among MHD 
patients, and to evaluate the feasibility and effectiveness of promoting exercise 
rehabilitation techniques (ERT). 
The central concept of this study is to integrate individualized exercise rehabilitation 
into routine hemodialysis sessions, providing a safe, controlled, and cost-effective 
intervention. The ERT consists of three phases: warm-up, core exercise, and 
relaxation. Warm-up includes simple stretching and limb movements to prepare 
patients for exercise; the core phase involves upper-limb resistance training and 
bedside cycling to progressively improve muscle strength and endurance; relaxation 
activities relieve post-exercise tension and improve comfort and compliance. The 
study will primarily evaluate the effects of ERT on physical function, psychological 
health, nutritional status, cognitive function, and overall quality of life in MHD 
patients, while also recording hospitalization and mortality as key clinical endpoints. 
II. Study Objectives 
The objective of this study is to evaluate functional impairment in MHD patients in 

 
3 
accordance with the Standards, and to promote exercise rehabilitation practices. The 
study aims to determine whether standardized rehabilitation interventions can 
improve functional impairment, reduce hospitalization and mortality, and enhance 
clinical prognosis in MHD patients. 
 
III. Study Design and Methods 
1) Study Population: 
Eligible participants are MHD patients meeting the following criteria: undergoing 
regular dialysis for >3 months, three sessions per week, Kt/V ≥ 1.2, clinically stable, 
aged 18–74 years, and able to provide written informed consent. Exclusion criteria 
include NYHA class IV heart failure, recent unstable angina, severe peripheral 
arterial disease or musculoskeletal disorders, walking distance <200 meters, or 
oxygen saturation <90%. These criteria ensure participants can tolerate exercise 
interventions and complete follow-up. 
2) Interventions: 
The intervention is based on the Standards for rehabilitation services in CKD 
patients. The intervention group will receive structured ERT in addition to routine 
hemodialysis. The program includes: 
1. 
Warm-up (e.g., stretching, leg raises), 
2. 
Core exercise (e.g., upper-limb resistance training, bedside cycling), 
3. 
Relaxation (e.g., whole-body stretching). 
Each session lasts 20–60 minutes, three times weekly, for two years. The control 
group receives only routine hemodialysis without additional exercise. All sessions 
will be supervised by trained healthcare staff, and individualized prescriptions will 
be adjusted according to patient conditions to ensure safety and feasibility. 
3) Sample Collection: 
This study will recruit 800 MHD patients across 15 hemodialysis centers in China, 
with 40 participants planned at The First People’s Hospital of Yunnan Province. 
Eligible patients will be randomized to intervention or control groups using sealed 
envelopes. Baseline assessments will include demographics, medical history, 
laboratory tests (hemoglobin, albumin, electrolytes, inflammatory markers, etc.), and 
functional impairment evaluations. Follow-ups will occur every 6 months (5 times 
total), with an additional 5 mL blood sample collected at each visit for metabolomics 
and proteomics analyses. 
During the intervention, patient functional outcomes (e.g., 6-minute walk test, 
muscle strength) and endpoints (hospitalization, mortality) will be recorded. All 

 
4 
samples and data will be anonymized, coded, and managed securely to ensure 
quality and confidentiality. At study completion, samples and data will be handled 
per regulatory requirements, and findings will provide scientific evidence for clinical 
adoption of ERT. 
IV. Inclusion and Exclusion Criteria 
Inclusion Criteria: 
1. 
On MHD ≥3 months, 
2. 
Age 18–74 years, 
3. 
Three sessions per week, Kt/V >1.2, 
4. 
Adequate standard medical management. 
Exclusion Criteria: 
1. 
NYHA class IV heart failure, 
2. 
Uncontrolled unstable angina, 
3. 
Severe peripheral arterial disease or musculoskeletal disease, 
4. 
Walking distance <200 m, 
5. 
Resting SpO₂ <90%, 
6. 
Amputation or other conditions preventing exercise. 
Endpoint Events: 
1. Cardiovascular events: acute myocardial infarction, other acute coronary 
syndromes, hospitalized congestive heart failure, severe arrhythmia (e.g., 
complete AV block, cardiac arrest). 
2. Cerebrovascular events: intracerebral hemorrhage, subarachnoid hemorrhage, 
ischemic stroke (including cardioembolic stroke). 
3. Exercise-related hospitalizations and mortality. 
Withdrawal Criteria: 
Participants will be withdrawn if any of the following occur (recorded in “Clinical 
Event Form”): 
1. 
Major changes in dialysis modality (frequency, switch to high-flux dialysis, 
additional blood purification techniques), 
2. 
Pregnancy, 
3. 
Switch to peritoneal dialysis, 
4. 
Kidney transplantation, 

 
5 
5. 
Withdrawal of informed consent, 
6. 
Loss to follow-up (including transfer to another hospital), 
7. 
Completion of scheduled follow-up. 
Withdrawn cases will be censored in data analysis. 
V. Participant Protection Measures 
1. Participant Management 
①. Recruitment: 
Patients will be screened from the Department of Nephrology, Hemodialysis 
Center, The First People’s Hospital of Yunnan Province, based on inclusion 
and exclusion criteria. Assessment will be conducted by qualified physicians 
to ensure no additional risk of disease progression from study participation. 
②. Informed Consent: 
Trained staff will explain study objectives, procedures, potential risks, and 
benefits. Participants will be assured that their routine treatment will not be 
affected. Written informed consent will be obtained from participants with 
full decisional capacity. Privacy and information security will be ensured 
during the consent process. 
③. Confidentiality: 
Personal information will be strictly protected. Data will be anonymized or 
coded and used only for statistical purposes. All procedures will comply 
with the Personal Information Protection Law and ethical standards. 
④. Compensation: 
At each follow-up visit (every 6 months, total 5 visits), an additional 5 mL 
blood sample will be collected. All procedures will follow clinical and 
ethical standards. Participants will receive financial compensation of 50 
RMB per sample, settled in a lump sum at study completion. 
2. Data Safety and Monitoring 
①. Data Management: 
Data will be stored in an electronic management system with integrity, 
security, and audit traceability. Regular backups will be performed. 
②. Statistical Analysis: 
After data collection, descriptive and inferential statistics will be conducted 
using SPSS. Analyses will include measures of central tendency and 
dispersion, correlation tests, and multivariate regression to explore 
relationships between variables. 

 
6 
③. Ethics Committee Reporting: 
A final summary report will be submitted upon study completion, including 
baseline characteristics, analysis results, and study conclusions. 
3. Biological Samples: 
Collection and use of biological samples (e.g., blood) will be restricted to the 
purposes defined in informed consent. Storage and disposal will comply with 
regulatory requirements.