End-stage Renal Disease (ESRD)NCT05649657
Effect of Lifestyle Intervention in Patients With Chronic Kidney Disease on Fitness and Immune Function
A study testing Cyclic aerobic and resistance training in people with End-stage Renal Disease (ESRD), run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
To assess the efficacy of a 6-month lifestyle intervention in patients with end-stage renal disease(ESRD), we plan to conduct a self-controlled clinical trial. 34 participants receiving chronic HD will be enrolled. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- End-stage Renal Disease (ESRD)
- What is being tested?
- Cyclic aerobic and resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2020to 28 Feb 2025
- Phase
- Interventional
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who are on HD for longer than 6 months
- under the permission of their nephrologist
- adequately dialyzed (most recent Kt/V > 1.2) and stable during dialysis in the past 3 months
Who cannot join
- occurrence of hyperkalemia in the past 3 months
- comorbid medical, physical, and mental conditions that contraindicate exercise
- unstable cardiac conditions (eg, unstable angina, heart failure or symptomatic severe aortic stenosis, etc.)
- disabling orthopedic and neuromuscular diseases
Trial locations and contacts
1 site in 1 country.
About this study
To assess the efficacy of a 6-month lifestyle intervention in patients with end-stage renal disease(ESRD), we plan to conduct a self-controlled clinical trial. 34 participants receiving chronic HD will be enrolled. Each participant will go through three phases: 3-month control, 6-month intervention, and 3-month maintenance. No intervention will be performed in the control and maintenance phases. The lifestyle intervention will comprise care from a multidisciplinary team, including a nephrologist, nurse practitioner, physiatrist, and dietitian. The exercise training component is an in-hospital supervised training 2~3 times weekly for 6 months. Cyclic aerobic and resistance training will be performed. Assessment will be performed every three months and 5 times in total, including cardiopulmonary exercise testing, isokinetic quadriceps strength testing, hand grip strength, body composition analysis, Chinese Kidney Disease and Quality of Life questionnaire, self-recorded physical activity, and Mini Nutritional Assessment. The aim of this study is to assess the efficacy of a lifestyle intervention in patients with chronic kidney disease (CKD) on physical fitness, quality of life, and immunity. It is hypothesized that the lifestyle intervention will elicit a significant benefit in the aforementioned parameters and will last until the maintenance phase.
Read the detailed description
The prevalence of end-stage renal disease is high, especially in Taiwan. Cardiovascular diseases and infection are the major causes of morbidity. Though evidence is clear that exercise training in this population is beneficial to fitness、quality of life、morbidity, it is seriously underused. Poor physical fitness is known to associate with high-leveled systemic inflammation and immune dysregulation but the detailed relationship remains unclear in the ESRD population. Moreover, though exercise improves low physical fitness, available research concerning its effect on the pro-/anti-inflammatory immune response is scarce. Does supervised lifestyle intervention has the potential to improve physical fitness, and quality of life in patients receiving maintenance hemodialysis (HD)? To assess the efficacy of a 6-month lifestyle intervention in patients under HD, we plan to conduct a self-controlled clinical trial. No intervention will be performed in the control and maintenance phases. The lifestyle intervention will comprise care from a multidisciplinary team, including a nephrologist, nurse practitioner, physiatrist, and dietitian. The exercise training component is in-hospital supervise training 2~3 times weekly for 6 months. Cyclic aerobic and resistance training will be performed. Assessment will be performed every three months and 5 times in total, including cardiopulmonary exercise testing, isokinetic quadriceps strength testing, hand grip strength, body composition analysis, Chinese Kidney Disease and Quality of Life questionnaire, self-recorded physical activity, and Mini Nutritional Assessment. The aim of this study is to assess the efficacy of a lifestyle intervention in patients under HD on physical fitness, and quality of life. It is hypothesized that the lifestyle intervention will elicit a significant benefit in the aforementioned parameters and will last until the maintenance phase.
- Conditions
- End-stage Renal Disease (ESRD)
- Being tested
- Cyclic aerobic and resistance training
- Keywords
- exercise, hemodialysis
- Medical subject headings
- Kidney Failure, Chronic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclic aerobic and resistance trainingOther
Two options for the participants to choose from. First, a home-based program. The participant will be requested to wear a heart rate recorder during home exercise. Second, a hospital-based program. The participants visit the rehabilitation center twice weekly to receive supervised exercise therapy. The exercise prescription comprises aerobic and resistance training. The intensity is set initially at ventilatory anaerobic threshold and gradually titrated up to respiratory compensatory point based on the breath-by-breath cardiopulmonary exercise testing. The duration is 25~35 minutes per session plus a 5-minute warm-up and 5-min cool-down. The frequency is 2~3 sessions per week and about 70 sessions in total.
| Study group | Role | What they receive |
|---|---|---|
| hemodialysis patients with exercise training intervention | Experimental | The participants under hemodialysis for over 3 months will go through three phases: 3-month control, 6-month intervention, and 3-month maintenance. No intervention will be performed in the control and maintenance phases Receives: Other: Cyclic aerobic and resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Oxygen Consumption
cardiopulmonary exercise testing
Measured: 1 year
Inflammatory Cytokines
Interleukin (IL)-6 concentration was detected in plasma using the BD Cytometric Bead Array (CBA) Human Inflammatory Cytokines Kit (Becton-Dickinson) and analyzed with FCAP Array™ software .
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start1 Jul 2020
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End-stage Renal Disease (ESRD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shu-Chun Huang, MD, PhD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649657
- Sponsor's protocol ID
- 202201244B0A3
- Status last verified
- Oct 2022
- First submitted
- 7 Nov 2022
- Last updated
- 19 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Huang SC, Fang JT, Huang YC, Lin CY, Hsiao CC. From gains to decline: effects of structured pre-dialytic exercise training and detraining on physical fitness, quality of life, and inflammation in haemodialysis patients. J Rehabil Med. 2025 Oct 22;57:jrm44067. doi: 10.2340/jrm.v57.44067.
PubMed 41126503