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

NCT06551311 | Recruiting

• 1 other identifier: A-BR-110-109
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Kidney Disease

Keywords

Eccentric Cycling Exercise Training; Chronic Kidney Disease

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• Physical fitness-Body composition

  at Baseline, midterm test (at 4 weeks), post-test (at 8 weeks), and follow-up test (at 12 weeks)

• Physical fitness-Flexibility

  at Baseline, midterm test (at 4 weeks), post-test (at 8 weeks), and follow-up test (at 12 weeks)

• Physical fitness-muscle strength

  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

  at Baseline and follow up test (at 12 weeks)

• Quality of life indicators- KDQOL Questionnaire

  at Baseline and follow up test (at 12 weeks)

Study Arms (3)

Control group

NO INTERVENTION

Receive regular health care

The concentric cycling exercise training group

EXPERIMENTAL

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

The eccentric cycling exercise training group

EXPERIMENTAL

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

Interventions

cycling training exercise BEHAVIORAL

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.

The concentric cycling exercise training group; The eccentric cycling exercise training group

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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

Sponsors & Collaborators

• National Cheng Kung University: lead

Study Sites (1)

National Cheng Kung University Hostipal

Tainan, Taiwan, 701, Taiwan

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Kun-Ling Tsai, Ph.D.

CONTACT

886-6-2353535 Ext. 6219; kunlingtsai@mail.ncku.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair Department of Physical Therapy/Institute of Allied Health Science National Cheng Kung University

Model Details: In this randomized controlled trial, participants were assigned to one of three groups: the concentric cycling exercise training group, the eccentric cycling exercise training group, or the control group with no exercise intervention. Over eight weeks, participants completed 24 exercise sessions, three times per week, with each session lasting between 20 and 30 minutes. The allocation of participants to groups was determined using a random numbers table.

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: August 13, 2024
• Study Start: July 1, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)