The Effects of Eccentric Cycling Exercise Program in Chronic Kidney Disease Patients
NCT Number: NCT06551311
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Kidney Disease
Interventions: BEHAVIORAL: cycling training exercise
Sponsor: National Cheng Kung University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2023-07-01
Completion Date: 2025-12-31
Locations: National Cheng Kung University Hostipal, Tainan, 701, Taiwan

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.

Primary Outcome Measures: 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: 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)