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

Primary Purpose

Chronic Kidney Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Cyclic aerobic and resistance training
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Diseases

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

CKD patients with exercise training intervention

CKD stage 1 and 2

CKD stage 1 and 2 respectively, and 20 healthy subjects

Arm Description

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

no inervention

no inervention

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
November 7, 2022
Last Updated
December 12, 2022
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05649657
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2022 (Actual)
Primary Completion Date
September 18, 2024 (Anticipated)
Study Completion Date
September 18, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CKD patients with exercise training intervention
Arm Type
Experimental
Arm Description
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
Arm Title
CKD stage 1 and 2
Arm Type
No Intervention
Arm Description
no inervention
Arm Title
CKD stage 1 and 2 respectively, and 20 healthy subjects
Arm Type
No Intervention
Arm Description
no inervention
Intervention Type
Other
Intervention Name(s)
Cyclic aerobic and resistance training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Exercise capacity of all participants by Cardiopulmonary Exercise Test (CPET)
Description
Cardiopulmonary Exercise Test cardiopulmonary exercise test.
Time Frame
three years
Title
To examine the levels of inflammatory chemokines in the circulation of participants by Luminex assay
Description
Luminex assay
Time Frame
three years
Title
To detect the levels of anti-inflammatory microRNAs in the circulation of participants by qPCR
Description
qPCR
Time Frame
three years
Title
To study various populations of immune cells in the circulation of patients
Description
flow cytometry
Time Frame
three years
Secondary Outcome Measure Information:
Title
To evaluate the association between fitness and immune responses by the questionnaire of Hong Kong Chinese Kidney Disease and Quality of Life
Description
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.
Time Frame
three years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shu-Chun Huang, MD, PhD
Phone
+8863281200
Ext
5156
Email
mr7171@cgmh.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shu-Chun Huang, MD, PhD
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shu-Chun Huang, MD, PhD
Phone
+8863281200
Ext
5156
Email
mr7171@cgmh.org.tw

12. IPD Sharing Statement

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

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