The Effects of Eccentric Cycling Exercise Program in Chronic Kidney Disease Patients

To Explore Efficacy and Load of Eccentric Cycling Training in Older CKD Patients with or Without Sarcopenia

Progress in medical technology, enhancements in environmental cleanliness, and elevated living conditions have notably prolonged the mean life expectancy, resulting in a swift increase in the aging population. The prevalence of Chronic Kidney Disease (CKD) is more pronounced among the elderly in contrast to younger demographics. With the aging of the CKD population, the capacity to autonomously handle daily activities becomes a critical concern. This demographic frequently encounters concurrent health conditions, a decrease in self-care capabilities, general health decline, and diminished quality of life.

Recent studies suggest that physical activity has the potential to enhance cardiovascular health, cardiopulmonary endurance, muscle strength, quality of life, uremic toxin management, and inflammation levels among individuals with CKD. Given that CKD patients often exhibit sedentary behavior and reduced exercise capacity, eccentric cycling exercises may be particularly well-suited for this demographic.

Compared to concentric contractions, eccentric contractions subject the muscles to higher tension. Since muscle growth partially depends on the "stress exerted on muscle fibers"-meaning the greater the stress, the more stimulation the muscles receive-training focused on eccentric contractions could provide more stimulation and promote greater muscle growth.

In recent studies, eccentric cycling has emerged as a feasible and promising aerobic exercise intervention. It can provide a safe and appropriate amount of exercise while relatively reducing joint pressure. This novel combined aerobic and anaerobic exercise method is particularly beneficial for individuals with weaker lower limb muscles, lower joint pressure tolerance, poor metabolic and cardiovascular function, and a tendency to fatigue.

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Behavioral: cycling training exercise

Detailed Description

The previous study did not examine the impact of eccentric cycling exercise training on individuals with CKD. This study focuses on exploring the effects of eccentric cycling exercise on various aspects including body composition, functional capacity, flexibility, muscle strength, exercise capacity, pulmonary function, quality of life, and renal function in CKD patients. A comparison will be made between eccentric cycling exercise training, concentric cycling exercise training, and the usual care provided. The goal is to provide a clearer understanding of how eccentric cycling exercise can benefit individuals with CKD.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kun-Ling Tsai, Ph.D.; Phone Number: 886-6-2353535 Ext. 6219; Email: kunlingtsai@mail.ncku.edu.tw

Study Locations

• Taiwan
  • Tainan, Taiwan, 701
    • Recruiting
    • National Cheng Kung University Hostipal
    • Contact: Kun-Ling Tsai, PhD; Phone Number: 6219 062353535; Email: kunlingtsai@mail.ncku.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

This study will be conducted in collaboration with the Departments of Nephrology and Geriatric Medicine at National Cheng Kung University Hospital, Taiwan. Participants will be recruited as voluntary subjects from outpatient clinics. The attending physician will assess eligible patients. After the study's purpose and methodology are explained by the research staff and patients consent to participate, block randomization will be used to assign participants into one of three groups randomly. The allocation results will be securely stored by the principal investigator.

Inclusion Criteria:

• (1) Clinical diagnosis of CKD
• (2) eGFR <60 ml/min/1.73m^2 or undergoing routine dialysis
• (3) Must be able to communicate normally, understand and comply with instructions.
• (4) Must be able to walk independently.

Exclusion Criteria:

• (1) Clinical diagnosis of acute renal failure
• (2) Hospitalization for acute illness within the past three months
• (3) Clinical diagnosis of severe joint disease and lower extremity surgery
• (4) Clinical diagnosis of severe neurological disease
• (5) Clinical diagnosis of severe cardiovascular disease
• (6) Unconsciousness or lack of ability to cooperate with the assessment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Receive regular health care
Experimental: The concentric cycling exercise training group; Over eight weeks, participants completed 24 exercise sessions, three times per week, with each session lasting between 20 and 30 minutes under concentric cycling exercise training.	Behavioral: cycling training exercise; Participants were randomly allocated to one of three groups: control (CTL), concentric cycling training (CON), or eccentric cycling training (ECC). CTL: Received standard health education guidance. CON and ECC: Participants in both the CON and ECC groups engaged in 24 exercise sessions, performed three times per week, lasting between 20 and 30 minutes. Both groups trained on a stationary bicycle, with the CON group performing concentric cycling and the ECC group performing eccentric cycling. The exercise intensity for both groups was set to a rating of perceived exertion (RPE) level of 13. Sessions began at 20 minutes and increased incrementally by 3-5 minutes each week until participants could sustain a 30-minute duration. The initial exercise intensity was set at 50% of the maximal output determined by a cardiopulmonary exercise test, and it was progressively increased by 5-10% of the estimated target power weekly, with adjustments made primarily to maintain an RPE of 13.
Experimental: The eccentric cycling exercise training group; Over eight weeks, participants completed 24 exercise sessions, three times per week, with each session lasting between 20 and 30 minutes under eccentric cycling exercise training.	Behavioral: cycling training exercise; Participants were randomly allocated to one of three groups: control (CTL), concentric cycling training (CON), or eccentric cycling training (ECC). CTL: Received standard health education guidance. CON and ECC: Participants in both the CON and ECC groups engaged in 24 exercise sessions, performed three times per week, lasting between 20 and 30 minutes. Both groups trained on a stationary bicycle, with the CON group performing concentric cycling and the ECC group performing eccentric cycling. The exercise intensity for both groups was set to a rating of perceived exertion (RPE) level of 13. Sessions began at 20 minutes and increased incrementally by 3-5 minutes each week until participants could sustain a 30-minute duration. The initial exercise intensity was set at 50% of the maximal output determined by a cardiopulmonary exercise test, and it was progressively increased by 5-10% of the estimated target power weekly, with adjustments made primarily to maintain an RPE of 13.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiopulmonary Exercise Testing (CPET)	CPET evaluates both submaximal and peak exercise responses of the pulmonary, cardiovascular, hematopoietic, neuropsychological, and skeletal muscle systems for diagnostic and prognostic assessment. It aims to assess exercise performance, functional capacity, and impairment by identifying undiagnosed exercise intolerance and symptoms.	at Baseline, midterm test (at 4 weeks), post-test (at 8 weeks), and follow-up test (at 12 weeks)
Pulmonary function test	Spirometry is a physiological test that measures the ability to inhale and exhale air over time. The main spirometry results are forced vital capacity (FVC), forced expiratory volume in the first second (FEV1), and the FEV1/FVC ratio.	at Baseline, midterm test (at 4 weeks), post-test (at 8 weeks), and follow-up test (at 12 weeks)
Maximum respiratory pressure (MIP/MEP)	Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measurements help evaluate respiratory muscle weakness.	at Baseline, midterm test (at 4 weeks), post-test (at 8 weeks), and follow-up test (at 12 weeks)
Six Minute Walk Test (6MWT)	The American Thoracic Society developed the 6-minute walk test (6MWT) to assess patients with cardiopulmonary issues and has since been used for various other conditions. It is a low-intensity, submaximal exercise test that measures aerobic capacity, endurance, and oxygen saturation.	at Baseline, midterm test (at 4 weeks), post-test (at 8 weeks), and follow-up test (at 12 weeks)
Lower limb strength-Knee Extension Strength Test	The Knee Extension Strength Test is a clinical assessment used to measure the maximal force production of the quadriceps muscles in both legs (bilateral lower limb strength). It's a valuable tool for identifying muscle weakness, tracking progress after injury or rehabilitation, and guiding treatment decisions.	at Baseline, midterm test (at 4 weeks), post-test (at 8 weeks), and follow-up test (at 12 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical fitness-Body composition	Body composition is a key component for maintaining good general. Body composition refers to the distribution of fat, muscle, bone, and other tissues that make up your body. It is often expressed as the percentage of total body weight that consists of fat and/or lean body mass. Body composition offers numerous insights into health, fitness, and nutritional status. Utilize Bioelectrical Impedance Analysis (BIA) equipment to assess a range of body composition parameters, including high (m^2), weight (kg), body fat (%), Skeletal muscle rate (%), basal metabolic rate, and BMI (kg/m^2).	at Baseline, midterm test (at 4 weeks), post-test (at 8 weeks), and follow-up test (at 12 weeks)
Physical fitness-Flexibility	Flexibility, the ability to move joints through their full range of motion, is key for physical health. Upper limb test: Apley scratch test assess shoulder flexibility, helping gauge overall mobility.	at Baseline, midterm test (at 4 weeks), post-test (at 8 weeks), and follow-up test (at 12 weeks)
Physical fitness-muscle strength	Muscle strength is characterized as the maximum force that a muscle or a group of muscles can produce at a specific or predetermined velocity. In essence, it refers to the capacity of skeletal muscle to generate force, which is crucial for ensuring stability and mobility within the musculoskeletal system. Upper arm testing-hand grip test: The purpose of the handgrip strength test is to measure the maximum isometric strength of the hand and forearm muscles. The subject holds the dynamometer in the hand to be tested, with the arm at right angles and the elbow by the side of the body. The handle of the dynamometer is adjusted if required - the base should rest on the first metacarpal (heel of palm), while the handle should rest on middle of the four fingers. When ready the subject squeezes the dynamometer with maximum isometric effort, which is maintained for about 5 seconds. No other body movement is allowed. The subject should be strongly encouraged to give a maximum effort. Lower	at Baseline, midterm test (at 4 weeks), post-test (at 8 weeks), and follow-up test (at 12 weeks)
Quality of life indicators-SF-36 Questionnaire	SF-36 is a very popular instrument for evaluating Health-Related Quality of Life. The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). the score is in two steps. Precoded numerical values are first recorded by the scoring key in eight scales. Each item is rated, and a higher number indicates that the subject is in better overall health. Also, each item is graded on a scale of 0 to 100, with 0 and 100 as the lowest and highest possible scores. The eight scale scores are produced in step 2 by averaging the items on the same scale. There are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS). All scales contribute in different proportions to the scoring of both PCS and MCS measures.	at Baseline and follow up test (at 12 weeks)
Quality of life indicators- KDQOL Questionnaire	Health-related quality of life is a crucial outcome for the chronic kidney disease population, the Kidney Disease Quality of Life (KDQOL) questionnaire is commonly used as an integral part of clinical evaluations. The KDQOL-36™ is a short form that includes the SF-12 as generic core plus the burden of kidney disease, symptoms/problems of kidney disease, and effects of kidney disease scales from the KDQOL-SF™v1.3. Items 1-12: SF-12 Items 13-16: Burden of kidney disease Items 17-28: Symptoms/problems Items 29-36: Effects of kidney disease	at Baseline and follow up test (at 12 weeks)

Collaborators and Investigators

• Sponsor: National Cheng Kung University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 16, 2024
• First Submitted That Met QC Criteria: August 9, 2024
• First Posted (Actual): August 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Chronic Kidney Disease; Eccentric Cycling Exercise Training
• 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; Renal Insufficiency, Chronic
• Other Study ID Numbers: A-BR-110-109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD sharing plan will be decided after summarized data being published.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No