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Recruiting
NCT05649657
Effect of Lifestyle Intervention in Patients With Chronic Kidney Disease on Fitness and Immune Function
Conditions: Chronic Kidney Diseases
Sex: All
Ages: 20 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 160
Sponsor: Chang Gung Memorial Hospital
Location: Taiwan
Summary
To assess the efficacy of a 6-month lifestyle intervention in patients with CKD, we plan to conduct a self-controlled clinical trial.
120 participants with CKD stage 3-5 will be enrolled.
In addition, 20 participants with CKD stages 1 and 2 respectively, and 20 healthy subjects will be recruited; they will receive physical fitness and immune function assessment once; no intervention will be given.
The participants with 3-5 CKD 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 will offer two options for the participants to choose from.
First, a two-week individualized and supervised center-based exercise intervention followed by 6 months of a home-based program with refresher visits once per month.
The participant will be requested to wear a heart rate recorder during home exercise.
Second, persistent in-hospital 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 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 with CKD in stages 3-5patients who are on HD for longer than 6 monthsunder the permission of their nephrologistadequately dialyzed (most recent Kt/V > 1.2) and stable during dialysis in the past 3 monthsExclusion Criteria:occurrence of hyperkalemia in the past 3 monthscomorbid medical, physical, and mental conditions that contraindicate exerciseunstable cardiac conditions (eg, unstable angina, heart failure or symptomatic severe aortic stenosis, etc.)disabling orthopedic and neuromuscular diseases
Source: ClinicalTrials.gov (NCT05649657). StuddyBuddy aggregates publicly available trial information.