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End-Stage Renal Disease (ESRD)NCT07303179

Exercise Rehabilitation for Functional Impairment in Maintenance Hemodialysis Patients

A study testing Exercise Rehabilitation Therapy (ERT) in people with End-Stage Renal Disease (ESRD) and Maintenance Hemodialysis (MHD), run by The First People's Hospital of Yunnan at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 74 years
What is being tested?
Exercise Rehabilitation Therapy (ERT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
1 Jun 2025to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site
  • The First People's Hospital of Yunnan Province

    Kunming, Yunnan, 650032

Other trials in China

About this study

Official title: 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.

Read more

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.

Being tested
Exercise Rehabilitation Therapy (ERT)
Keywords
Exercise Rehabilitation, Maintenance Hemodialysis, Physical Function
Medical subject headings
Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise Rehabilitation Therapy (ERT)Behavioural

    Also called Exercise Rehabilitation Therapy, Exercise Training Program

    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.

Study groups in NCT07303179
Study groupRoleWhat they receive
Exercise Rehabilitation GroupExperimentalThis 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.
Receives: Behavioral: Exercise Rehabilitation Therapy (ERT)
Control GroupNo interventionParticipants in this group will receive routine maintenance hemodialysis only, without any additional exercise intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: From enrollment until 2 years after the end of intervention.

  2. 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.

    Measured: From enrollment until 2 years after the end of intervention.

  3. 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.

    Measured: From enrollment until 2 years after the end of intervention.

  4. 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.

    Measured: From enrollment until 2 years after the end of intervention.

Secondary outcomes (20)
  1. 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)

    Measured: From enrollment until 2 years after the end of intervention.

  2. 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)

    Measured: From enrollment until 2 years after the end of intervention.

  3. 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).

    Measured: From enrollment until 2 years after the end of intervention.

  4. 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).

    Measured: From enrollment until 2 years after the end of intervention.

  5. 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).

    Measured: From enrollment until 2 years after the end of intervention.

  6. 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).

    Measured: From enrollment until 2 years after the end of intervention.

  7. 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)

    Measured: From enrollment until 2 years after the end of intervention.

  8. 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.

    Measured: From enrollment until 2 years after the end of intervention.

  9. 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.

    Measured: From enrollment until 2 years after the end of intervention.

  10. 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.

    Measured: From enrollment until 2 years after the end of intervention.

  11. 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.

    Measured: From enrollment until 2 years after the end of intervention.

  12. 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.

    Measured: From enrollment until 2 years after the end of intervention.

  13. 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.

    Measured: From enrollment until 2 years after the end of intervention.

  14. 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.

    Measured: From enrollment until 2 years after the end of intervention.

  15. 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.

    Measured: From enrollment until 2 years after the end of intervention.

  16. 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.

    Measured: From enrollment until 2 years after the end of intervention.

  17. 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.

    Measured: From enrollment until 2 years after the end of intervention.

  18. 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.

    Measured: From enrollment until 2 years after the end of intervention.

  19. 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.

    Measured: From enrollment until 2 years after the end of intervention.

  20. 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.

    Measured: From enrollment until 2 years after the end of intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2025
  2. Study start1 Jun 2025
  3. Primary completion1 Jun 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07303179
Sponsor's protocol ID
KFKT-1023-005
Status last verified
Feb 2026
First submitted
25 Sep 2025
Last updated
10 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Exercise Rehabilitation Therapy (ERT) in people with End-Stage Renal Disease (ESRD) and Maintenance Hemodialysis (MHD), run by The First People's Hospital of Yunnan at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in 6-minute walk distance (6MWD) (time frame: From enrollment until 2 years after the end of intervention.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.

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