Chronic Kidney DiseaseNCT06551311
The Effects of Eccentric Cycling Exercise Program in Chronic Kidney Disease Patients
A study testing cycling training exercise in people with Chronic Kidney Disease, run by National Cheng Kung University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- cycling training exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- (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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng Kung University Hostipal
Tainan, Taiwan, 701
Kun-Ling Tsai, PhD, 062353535 ext. 6219, kunlingtsai@mail.ncku.edu.tw
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Chronic Kidney Disease
- Being tested
- cycling training exercise
- Keywords
- Eccentric Cycling Exercise Training, Chronic Kidney Disease
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cycling training exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: cycling training exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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).
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: at Baseline and follow up test (at 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start1 Jul 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng Kung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kun-Ling Tsai, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06551311
- Sponsor's protocol ID
- A-BR-110-109
- Status last verified
- Dec 2024
- First submitted
- 16 Jul 2024
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD sharing plan will be decided after summarized data being published.
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Explore Efficacy and Load of Eccentric Cycling Training in Older CKD Patients with or Without Sarcopenia
- ClinicalTrials.gov ID
- NCT06551311
- Acronym / sponsor ID
- A-BR-110-109
- Conditions
- Chronic Kidney Disease
- Keywords
- Eccentric Cycling Exercise Training, Chronic Kidney Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- National Cheng Kung UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Receive regular health care |
| The concentric cycling exercise training group | Experimental | Behavioral: cycling training exerciseOver 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. |
| The eccentric cycling exercise training group | Experimental | Behavioral: cycling training exerciseOver 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. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- (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.
Key exclusion criteria (6 listed)
- (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cycling training exerciseParticipants 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. | Behavioural | The concentric cycling exercise training group, The eccentric cycling exercise training group |
Primary outcome
Cardiopulmonary Exercise Testing (CPET)
Time frame: at Baseline, midterm test (at 4 weeks), post-test (at 8 weeks), and follow-up test (at 12 weeks)
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.
Pulmonary function test
Time frame: at Baseline, midterm test (at 4 weeks), post-test (at 8 weeks), and follow-up test (at 12 weeks)
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.
Maximum respiratory pressure (MIP/MEP)
Time frame: at Baseline, midterm test (at 4 weeks), post-test (at 8 weeks), and follow-up test (at 12 weeks)
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measurements help evaluate respiratory muscle weakness.
Six Minute Walk Test (6MWT)
Time frame: at Baseline, midterm test (at 4 weeks), post-test (at 8 weeks), and follow-up test (at 12 weeks)
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.
Lower limb strength-Knee Extension Strength Test
Time frame: at Baseline, midterm test (at 4 weeks), post-test (at 8 weeks), and follow-up test (at 12 weeks)
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.
5 secondary outcomes
Physical fitness-Body composition
Time frame: at Baseline, midterm test (at 4 weeks), post-test (at 8 weeks), and follow-up test (at 12 weeks)
Physical fitness-Flexibility
Time frame: at Baseline, midterm test (at 4 weeks), post-test (at 8 weeks), and follow-up test (at 12 weeks)
Physical fitness-muscle strength
Time frame: 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
Time frame: at Baseline and follow up test (at 12 weeks)
Quality of life indicators- KDQOL Questionnaire
Time frame: at Baseline and follow up test (at 12 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Individual participant dataSharing planned: No. IPD sharing plan will be decided after summarized data being published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cycling training exercise in people with Chronic Kidney Disease, run by National Cheng Kung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kun-Ling Tsai, Ph.D. (886-6-2353535 Ext. 6219, kunlingtsai@mail.ncku.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiopulmonary Exercise Testing (CPET) (time frame: at Baseline, midterm test (at 4 weeks), post-test (at 8 weeks), and follow-up test (at 12 weeks)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.