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 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.

Study Overview

• Status: Completed
• Conditions: End-stage Renal Disease (ESRD)
• Intervention / Treatment: Other: Cyclic aerobic and resistance training

Detailed Description

The prevalence of end-stage renal disease is high, especially 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 ESRD 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, and quality of life in patients receiving maintenance hemodialysis (HD)? To assess the efficacy of a 6-month lifestyle intervention in patients under HD, we plan to conduct a self-controlled clinical trial. 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 in-hospital supervise 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 under HD on physical fitness, and quality of life. It is hypothesized that the lifestyle intervention will elicit a significant benefit in the aforementioned parameters and will last until the maintenance phase.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 333
    • Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: hemodialysis patients with exercise training intervention; The participants under hemodialysis for over 3 months 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Oxygen Consumption	cardiopulmonary exercise testing	1 year
Inflammatory Cytokines	Interleukin (IL)-6 concentration was detected in plasma using the BD Cytometric Bead Array (CBA) Human Inflammatory Cytokines Kit (Becton-Dickinson) and analyzed with FCAP Array™ software .	1 year

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): July 1, 2020
• Primary Completion (Actual): February 28, 2025
• Study Completion (Actual): February 28, 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): August 19, 2025
• Last Update Submitted That Met QC Criteria: August 17, 2025
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: exercise; hemodialysis
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Kidney Diseases; Kidney Failure, Chronic; 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