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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Diseases
• Intervention / Treatment: Other: Cyclic aerobic and resistance training

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.

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shu-Chun Huang, MD, PhD; Phone Number: 5156 +8863281200; Email: mr7171@cgmh.org.tw

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 333
    • Recruiting
    • Chang Gung memorial hospital
    • Contact: Shu-Chun Huang, MD, PhD; Phone Number: 5156 +8863281200; Email: mr7171@cgmh.org.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CKD patients with exercise training intervention; 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; 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.
No Intervention: CKD stage 1 and 2; no inervention
No Intervention: CKD stage 1 and 2 respectively, and 20 healthy subjects; no inervention

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Shu-Chun Huang, MD, PhD, Chang Gung memorial hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2022
• Primary Completion (Anticipated): September 18, 2024
• Study Completion (Anticipated): September 18, 2025

Study Registration Dates

• First Submitted: November 7, 2022
• First Submitted That Met QC Criteria: December 12, 2022
• First Posted (Actual): December 14, 2022

Study Record Updates

• Last Update Posted (Actual): December 14, 2022
• Last Update Submitted That Met QC Criteria: December 12, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 202201244B0A3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No