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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-85
SponsorNational Cheng Kung University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

(1) Clinical diagnosis of CKD

(2) eGFR <60 ml/min/1.73m² or undergoing routine dialysis

(3) Must be able to communicate normally, understand and comply with instructions.

(4) Must be able to walk independently.

Disqualifiers

(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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Control groupNo intervention 0 interventions
Group B: The concentric cycling exercise training groupExperimental treatment 1 intervention
Group C: The eccentric cycling exercise training groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
at Baseline, midterm test (at 4 weeks), post-test (at 8 weeks), and follow-up test (at 12 weeks)
2

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.

Time frame
at Baseline, midterm test (at 4 weeks), post-test (at 8 weeks), and follow-up test (at 12 weeks)
3

Maximum respiratory pressure (MIP/MEP)

Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measurements help evaluate respiratory muscle weakness.

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

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.

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

Secondary outcomes

1

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).

Time frame
at Baseline, midterm test (at 4 weeks), post-test (at 8 weeks), and follow-up test (at 12 weeks)
2

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.

Time frame
at Baseline, midterm test (at 4 weeks), post-test (at 8 weeks), and follow-up test (at 12 weeks)
3

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

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

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.

Time frame
at Baseline and follow up test (at 12 weeks)

Other outcomes

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