Effect of Lifestyle Intervention in Patients With Chronic Kidney Disease on Fitness and Immune Function

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Lifestyle Intervention in Patients With Chronic Kidney Disease on Fitness and Immune Function

Conditions
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Chronic Kidney Diseases

Intervention / Treatment
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* Other: Cyclic aerobic and resistance training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CKD patients with exercise training intervention<br>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 | Other: Cyclic aerobic and resistance training<br>* 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.<br>|
| No Intervention: CKD stage 1 and 2<br>no inervention | |
| No Intervention: CKD stage 1 and 2 respectively, and 20 healthy subjects<br>no inervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise capacity of all participants by Cardiopulmonary Exercise Test (CPET) | Cardiopulmonary Exercise Test cardiopulmonary exercise test. | three years | 
| To examine the levels of inflammatory chemokines in the circulation of participants by Luminex assay | Luminex assay | three years | 
| To detect the levels of anti-inflammatory microRNAs in the circulation of participants by qPCR | qPCR | three years | 
| To study various populations of immune cells in the circulation of patients | flow cytometry | three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the association between fitness and immune responses by the questionnaire of Hong Kong Chinese Kidney Disease and Quality of Life | The minimum and maximum values of the Hong Kong Chinese Kidney Disease and Quality of Life questionnaire are 0 and 100, separately. The higher scores mean a better outcome. | three years |