Clinical trial NCT05649657: Effect of Lifestyle Intervention in Patients With Chronic Kidney Disease on Fitness and Immune Function
Official title: Effect of Lifestyle Intervention in Patients With Chronic Kidney Disease on Fitness and Immune Function
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Kidney Diseases
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2022-12-14
Enrollment: 160
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The prevalence of chronic kidney disease (CKD) in stages 3\~5 is as high as 11.6% 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 CKD 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, quality of life and immunity in patients with chronic kidney disease (CKD)? 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. The goal for each year is as follows. The FIRST year: To explore the relationship between physical fitness and pro-/anti-inflammatory immune response in different stages of CKD patients; the SECOND year: to assess the effect of lifestyle intervention on physical fitness, QOL, sedentary time, and nutrition status; the THIRD year: To evaluate the effects of lifestyle intervention on immunity.

Eligibility criteria: Inclusion Criteria:

* patients with CKD in stages 3-5
* 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

Primary outcomes:
measure: Exercise capacity of all participants by Cardiopulmonary Exercise Test (CPET)
timeFrame: three years
measure: To examine the levels of inflammatory chemokines in the circulation of participants by Luminex assay
timeFrame: three years
measure: To detect the levels of anti-inflammatory microRNAs in the circulation of participants by qPCR
timeFrame: three years
measure: To study various populations of immune cells in the circulation of patients
timeFrame: three years
Secondary outcomes:
measure: To evaluate the association between fitness and immune responses by the questionnaire of Hong Kong Chinese Kidney Disease and Quality of Life
timeFrame: three years
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Shu-Chun Huang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: