N/A
N=34
Effect of Lifestyle Intervention in Patients With Chronic Kidney Disease on Fitness and Immune Function
End-stage Renal Disease (ESRD)
Bottom Line
View on ClinicalTrials.gov: NCT05649657 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Peak Oxygen Consumption — 3.07 ml/min/kg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cyclic aerobic and resistance training (Other)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Chang Gung Memorial Hospital
- Primary completion
- Feb 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Oxygen Consumption |
3.07 | — |
| PRIMARY Inflammatory Cytokines |
2.84 | — |
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. 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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT05649657). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.