Clinical trial NCT06551311: The Effects of Eccentric Cycling Exercise Program in Chronic Kidney Disease Patients
Official title: To Explore Efficacy and Load of Eccentric Cycling Training in Older CKD Patients with or Without Sarcopenia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: Eccentric Cycling Exercise Training
Chronic Kidney Disease
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 90
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cardiopulmonary Exercise Testing (CPET)
timeFrame: at Baseline, midterm test (at 4 weeks), post-test (at 8 weeks), and follow-up test (at 12 weeks)
measure: Pulmonary function test
timeFrame: at Baseline, midterm test (at 4 weeks), post-test (at 8 weeks), and follow-up test (at 12 weeks)
measure: Maximum respiratory pressure (MIP/MEP)
timeFrame: at Baseline, midterm test (at 4 weeks), post-test (at 8 weeks), and follow-up test (at 12 weeks)
measure: Six Minute Walk Test (6MWT)
timeFrame: at Baseline, midterm test (at 4 weeks), post-test (at 8 weeks), and follow-up test (at 12 weeks)
measure: Lower limb strength-Knee Extension Strength Test
timeFrame: at Baseline, midterm test (at 4 weeks), post-test (at 8 weeks), and follow-up test (at 12 weeks)
Secondary outcomes:
measure: Physical fitness-Body composition
timeFrame: at Baseline, midterm test (at 4 weeks), post-test (at 8 weeks), and follow-up test (at 12 weeks)
measure: Physical fitness-Flexibility
timeFrame: at Baseline, midterm test (at 4 weeks), post-test (at 8 weeks), and follow-up test (at 12 weeks)
measure: Physical fitness-muscle strength
timeFrame: at Baseline, midterm test (at 4 weeks), post-test (at 8 weeks), and follow-up test (at 12 weeks)
measure: Quality of life indicators-SF-36 Questionnaire
timeFrame: at Baseline and follow up test (at 12 weeks)
measure: Quality of life indicators- KDQOL Questionnaire
timeFrame: at Baseline and follow up test (at 12 weeks)
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hostipal
Study officials:
References: