Chronic Kidney DiseaseNCT07288905
Exploring the Effects of Exercise Combined With BFRT on Healthy and Patients With CKD
A study testing Aerobic exercise, Blood flow restriction and Resistance exercise in people with Chronic Kidney Disease, run by National Cheng Kung University at 1 site in Taiwan.
Trial summary
Investigate the effects of exercise training on the cardiopulmonary function and exercise capacity in healthy and CKD patients Read more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Aerobic exercise, Blood flow restriction and Resistance exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Oct 2025to 31 Dec 2030
- 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 20 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 20~85 years old
- Aged 20~85 years old
- eGFR< 90 ml/min/1.73 m2 over 3 months
- Stable condition without worsening in the past 3 months
- Ability to understand and follow verbal commends and cooperate with an exercise training program
Who cannot join
- Severe uncontrolled metabolic diseases (e.g., hyperthyroidism, diabetes, hypertension, hyperlipidemia, etc.)
- Severe pulmonary or cardiovascular diseases (e.g., pulmonary hypertension, chronic obstructive pulmonary disease (COPD), heart failure, cardiac arrhythmia)
- Presence of a cardiac pacemaker or a history of myocardial infarction within the past six months
- Severe musculoskeletal or neuromuscular disorders (e.g., advanced arthritis, limb amputation, post-polio syndrome, Parkinson's disease)
- Unstable vital signs (e.g., systolic blood pressure ≥180 mmHg, diastolic blood pressure ≥90 mmHg, requiring vasopressors, or resting heart rate >100 bpm)
- Prone to bruising
Show all 20Show fewer
- Recent inflection < 1 month
- Pregnancy
- Kidney function impairment
- Cancer
- Simultaneously participating in other research
- CKD
- Severe uncontrolled metabolic diseases (e.g., hyperthyroidism, diabetes, hypertension, hyperlipidemia, etc.)
- Severe pulmonary or cardiovascular diseases (e.g., pulmonary hypertension, chronic obstructive pulmonary disease (COPD), heart failure, cardiac arrhythmia)
- Presence of a cardiac pacemaker or a history of myocardial infarction within the past six months
- Severe musculoskeletal or neuromuscular disorders (e.g., advanced arthritis, limb amputation, post-polio syndrome, Parkinson's disease)
- Unstable vital signs (e.g., systolic blood pressure ≥180 mmHg, diastolic blood pressure ≥90 mmHg, requiring vasopressors, or resting heart rate >100 bpm)
- Abnormal blood biochemical parameters (e.g., white blood cell count <2500/mm³, hemoglobin <8 mg/dL, total bilirubin >3 mg/dL, liver enzymes (GOT/AST, GPT/ALT) >3 times the upper limit of normal, platelet count <75,000/mm³
- Sensory or motor dysfunctions that affect walking ability
- Diagnosed systemic diseases under ongoing treatment (e.g., systemic lupus erythematosus, cancer, malignancies).
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 Hospital
Tainan, 701
Kun-Ling Tasi, PhD, 062353535 Ext. 6219, Kunlingtsai@mail.ncku.edu.tw
About this study
Official title: The Feasibility and Effects of Exercise Training Combined With Blood Flow Restriction Training on Exercise Capacity and Exercise Tolerance in Patients With Chronic Kidney Disease
Investigate the effects of exercise training on the cardiopulmonary function and exercise capacity in healthy and CKD patients
Read the detailed description
Chronic kidney disease (CKD) is a condition characterized by impaired kidney function lasting for more than 3 months, as estimated by the glomerular filtration rate (eGFR), which is classified into stages 1 to 5. Common symptoms include swelling, fatigue, and high blood pressure. Previous studies have indicated that physical inactivity in patients with CKD, often due to fatigue, leads to decreased physical fitness. In addition, secondary complications such as muscle mass loss and weakness are frequently observed, especially in the advanced stages of CKD.
To address this vicious cycle, aerobic and resistance training have been shown to mitigate these effects. Previous studies have reported that such exercise interventions can reduce fatigue and improve VO₂ peak in individuals with CKD. However, these exercise programs often involve high loads and frequencies, which may not be feasible for some CKD patients, particularly those with comorbidities such as diabetes or cardiovascular disease.
The effectiveness of blood flow restriction (BFR) exercise compared with high-load training has been demonstrated in older adults, showing improvements in functional ability and muscular adaptation. Therefore, the purpose of this study is to investigate the effects of incorporating blood flow restriction during exercise on cardiopulmonary function and exercise capacity in patients with CKD.
- Conditions
- Chronic Kidney Disease
- Being tested
- Aerobic exercise, Blood flow restriction, Resistance exercise, Disease and exercise suggestion
- 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.
Aerobic exerciseBehavioural
The aerobic exercise intervention will utilize stationary bike. The program will be conducted 2 times per week over a 12 weeks
Blood flow restrictionBehavioural
Blood flow restriction intervention will combined aerobic exercise and resistance exercise. The program will be conducted 2 times per week over a 12 weeks
Resistance exerciseBehavioural
The resistance exercise will bilateral leg extension. The program will be conducted 2 times per week over a 12 weeks
Disease and exercise suggestionBehavioural
The participants will received self-care technique and home-based exercise approach
| Study group | Role | What they receive |
|---|---|---|
| healthy | Experimental | We will provide BFR combined with exercise Receives: Behavioral: Aerobic exercise; Behavioral: Blood flow restriction; Behavioral: Resistance exercise; Behavioral: Disease and exercise suggestion |
| CKD usual care group | Active comparator | We will provide patient education, home-based moderate to low-intensity rehabilitation Receives: Behavioral: Disease and exercise suggestion |
| CKD traditional rehabilitation group | Active comparator | We will provide aerobic exercise, resistance exercise training, and patient education Receives: Behavioral: Aerobic exercise; Behavioral: Resistance exercise; Behavioral: Disease and exercise suggestion |
| CKD BFR group | Experimental | We will provide BFR combined with exercise and patient education Receives: Behavioral: Aerobic exercise; Behavioral: Blood flow restriction; Behavioral: Resistance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragm excursion and thickness
Diaphragm excursion (unit: mm) and thickness (unit: mm) are examined by diaphragmatic ultrasound when a participant performs maximal inspiration and expiration
Measured: Change from baseline (0 week) to follow up (16 weeks)
Exercise capacity
A cardiopulmonary exercise test collects gases (including measures of oxygen consumption in ml/kg/min), which can be used to estimate exercise capacity
Measured: Change form baseline (0 week) to follow up (16 weeks)
Secondary outcomes (18)
Heart rate variability (Standard Deviation of Normal-to-Normal Intervals, SDNN)
Heart rate variability (HRV) is examined to assess the autonomic nervous system. Standard Deviation of Normal-to-Normal Intervals (SDNN, in ms)reflects overall heart rate variability and autonomic function
Measured: Change form baseline (0 week) to follow up (16 weeks)
Heart rate variability (Root Mean Square of Successive Differences, RMSSD)
Root Mean Square of Successive Differences (RMSSD in ms) represents short-term HRV and parasympathetic activity
Measured: Change form baseline (0 week) to follow up (16 weeks)
Heart rate variability (Low Frequency power, LF)
Low frequency power (LF, in ms²) reflects both sympathetic and parasympathetic modulation.
Measured: Change form baseline (0 week) to follow up (16 weeks)
Heart rate variability (High Frequency power, HF)
High frequency power (HF in ms²) reflects parasympathetic (vagal) activity.
Measured: Change from baseline (0 week) to follow-up (16 weeks)
Heart rate variability (LF/HF Ratio)
LF/HF ratio represents sympathovagal balance.
Measured: Change from baseline (0 week) to follow-up (16 weeks)
Pulmonary function test
Pulmonary function test is examined by spirometry, which measures the ability to inhale and exhale air over time. The results include forced vital capacity (FVC in L), forced exploratory volume in the first second (FEV1 in L), and the FVC/FEV1 ratio.
Measured: Change from baseline (0 week) to follow up (16 weeks)
Functional capacity
Functional capacity is examined by 6 minute walking test (6MWT, in m)
Measured: Change from baseline (0 week) to follow up (16 weeks)
Functional ability
Functional ability is examined using the Timed Up and Go (TUG) test, where the time taken (in seconds) to complete the test is recorded.
Measured: Change from baseline (0 week) to follow up (16 weeks)
Sit-and-Reach Test
Flexibility is examined by the sit and reach test (unit: cm).
Measured: Change from baseline (0 week) to follow up (16 weeks)
Handgrip Strength
Maximal voluntary handgrip strength. (unit: N)
Measured: Change from baseline (0 week) to follow-up (16 weeks)
Upper Limb Muscle Strength
Maximal voluntary contraction of upper limb muscles. (unit: N)
Measured: Change from baseline (0 week) to follow up (16 weeks)
Neck Muscle Strength
Maximal voluntary contraction of neck muscles. (unit: N)
Measured: Change from baseline (0 week) to follow up (16 weeks)
Knee Extensor Strength
Maximal voluntary contraction of the knee extensor muscles. (unit: N)
Measured: Change from baseline (0 week) to follow-up (16 weeks)
Maximum respiratory pressure
Maximum respiratory pressure is measured using a manometer, which records both maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP), in cmH₂O.
Measured: Change from baseline (0 week) to follow up (20 weeks)
Fatigue Severity Scale (FSS)
the Fatigue Severity Scale (FSS) is a 7-point scale questionnaire that measures the patient's level of fatigue. It contains 9 questions, and a total score of 36 points or higher indicates that the patient may be experiencing clinically significant fatigue and requires further evaluation.
Measured: Change form baseline (0 week) to follow up (16 weeks)
Kidney Disease Quality of Life (KDQOL)
The Kidney Disease Quality of Life (KDQOL) questionnaire is a standard tool for patients with kidney disease. It contains several subscales, and the raw scores are converted into normalized scores, with higher scores indicating better quality of life.
Measured: Change form baseline (0 week) to follow up (16 weeks)
Modified Medical Research Council (mMRC)
The modified Medical Research Council (mMRC) dyspnea scale consists of 4 levels that describe respiratory difficulty during daily activities; higher levels indicate more severe symptoms.
Measured: Change from baseline (0 week) to follow up (16 weeks)
Short Form-36 (SF-36)
The Short Form-36 (SF-36) measures physical and social health status, with higher scores representing better overall health
Measured: Change from baseline (0 week) to follow up (16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start4 Oct 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2030 (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
- Masking
- None (open label)
- Enrolment
- 120 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
- Investigators
- Kun-Ling Tasi, PhD, Principal investigator, Department of Physical Therapy, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07288905
- Sponsor's protocol ID
- B-ER-113-450
- Status last verified
- Dec 2025
- First submitted
- 16 Nov 2025
- Last updated
- 17 Dec 2025
- Results posted
- 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 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility and Effects of Exercise Training Combined With Blood Flow Restriction Training on Exercise Capacity and Exercise Tolerance in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT07288905
- Acronym / sponsor ID
- B-ER-113-450
- Conditions
- Chronic Kidney Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Cheng Kung UniversityUniversity, hospital or other
- Study start
- 4 Oct 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 17 Dec 2025 (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.
Investigate the effects of exercise training on the cardiopulmonary function and exercise capacity in healthy and CKD patients
Detailed description
Chronic kidney disease (CKD) is a condition characterized by impaired kidney function lasting for more than 3 months, as estimated by the glomerular filtration rate (eGFR), which is classified into stages 1 to 5. Common symptoms include swelling, fatigue, and high blood pressure. Previous studies have indicated that physical inactivity in patients with CKD, often due to fatigue, leads to decreased physical fitness. In addition, secondary complications such as muscle mass loss and weakness are frequently observed, especially in the advanced stages of CKD.
To address this vicious cycle, aerobic and resistance training have been shown to mitigate these effects. Previous studies have reported that such exercise interventions can reduce fatigue and improve VO₂ peak in individuals with CKD. However, these exercise programs often involve high loads and frequencies, which may not be feasible for some CKD patients, particularly those with comorbidities such as diabetes or cardiovascular disease.
The effectiveness of blood flow restriction (BFR) exercise compared with high-load training has been demonstrated in older adults, showing improvements in functional ability and muscular adaptation. Therefore, the purpose of this study is to investigate the effects of incorporating blood flow restriction during exercise on cardiopulmonary function and exercise capacity in patients with CKD.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| healthy | Experimental | Behavioral: Aerobic exercise, Behavioral: Blood flow restriction, Behavioral: Resistance exercise, Behavioral: Disease and exercise suggestionWe will provide BFR combined with exercise |
| CKD usual care group | Active comparator | Behavioral: Disease and exercise suggestionWe will provide patient education, home-based moderate to low-intensity rehabilitation |
| CKD traditional rehabilitation group | Active comparator | Behavioral: Aerobic exercise, Behavioral: Resistance exercise, Behavioral: Disease and exercise suggestionWe will provide aerobic exercise, resistance exercise training, and patient education |
| CKD BFR group | Experimental | Behavioral: Aerobic exercise, Behavioral: Blood flow restriction, Behavioral: Resistance exerciseWe will provide BFR combined with exercise and patient education |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 20~85 years old
- Aged 20~85 years old
- eGFR< 90 ml/min/1.73 m2 over 3 months
- Stable condition without worsening in the past 3 months
- Ability to understand and follow verbal commends and cooperate with an exercise training program
Key exclusion criteria (20 listed)
- Severe uncontrolled metabolic diseases (e.g., hyperthyroidism, diabetes, hypertension, hyperlipidemia, etc.)
- Severe pulmonary or cardiovascular diseases (e.g., pulmonary hypertension, chronic obstructive pulmonary disease (COPD), heart failure, cardiac arrhythmia)
- Presence of a cardiac pacemaker or a history of myocardial infarction within the past six months
- Severe musculoskeletal or neuromuscular disorders (e.g., advanced arthritis, limb amputation, post-polio syndrome, Parkinson's disease)
- Unstable vital signs (e.g., systolic blood pressure ≥180 mmHg, diastolic blood pressure ≥90 mmHg, requiring vasopressors, or resting heart rate >100 bpm)
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 |
|---|---|---|
| Aerobic exerciseThe aerobic exercise intervention will utilize stationary bike. The program will be conducted 2 times per week over a 12 weeks | Behavioural | CKD BFR group, CKD traditional rehabilitation group, healthy |
| Blood flow restrictionBlood flow restriction intervention will combined aerobic exercise and resistance exercise. The program will be conducted 2 times per week over a 12 weeks | Behavioural | CKD BFR group, healthy |
| Resistance exerciseThe resistance exercise will bilateral leg extension. The program will be conducted 2 times per week over a 12 weeks | Behavioural | CKD BFR group, CKD traditional rehabilitation group, healthy |
| Disease and exercise suggestionThe participants will received self-care technique and home-based exercise approach | Behavioural | CKD traditional rehabilitation group, CKD usual care group, healthy |
Primary outcome
Diaphragm excursion and thickness
Time frame: Change from baseline (0 week) to follow up (16 weeks)
Diaphragm excursion (unit: mm) and thickness (unit: mm) are examined by diaphragmatic ultrasound when a participant performs maximal inspiration and expiration
Exercise capacity
Time frame: Change form baseline (0 week) to follow up (16 weeks)
A cardiopulmonary exercise test collects gases (including measures of oxygen consumption in ml/kg/min), which can be used to estimate exercise capacity
18 secondary outcomes
Heart rate variability (Standard Deviation of Normal-to-Normal Intervals, SDNN)
Time frame: Change form baseline (0 week) to follow up (16 weeks)
Heart rate variability (Root Mean Square of Successive Differences, RMSSD)
Time frame: Change form baseline (0 week) to follow up (16 weeks)
Heart rate variability (Low Frequency power, LF)
Time frame: Change form baseline (0 week) to follow up (16 weeks)
Heart rate variability (High Frequency power, HF)
Time frame: Change from baseline (0 week) to follow-up (16 weeks)
Heart rate variability (LF/HF Ratio)
Time frame: Change from baseline (0 week) to follow-up (16 weeks)
Pulmonary function test
Time frame: Change from baseline (0 week) to follow up (16 weeks)
Functional capacity
Time frame: Change from baseline (0 week) to follow up (16 weeks)
Functional ability
Time frame: Change from baseline (0 week) to follow up (16 weeks)
Sit-and-Reach Test
Time frame: Change from baseline (0 week) to follow up (16 weeks)
Handgrip Strength
Time frame: Change from baseline (0 week) to follow-up (16 weeks)
Upper Limb Muscle Strength
Time frame: Change from baseline (0 week) to follow up (16 weeks)
Neck Muscle Strength
Time frame: Change from baseline (0 week) to follow up (16 weeks)
Knee Extensor Strength
Time frame: Change from baseline (0 week) to follow-up (16 weeks)
Maximum respiratory pressure
Time frame: Change from baseline (0 week) to follow up (20 weeks)
Fatigue Severity Scale (FSS)
Time frame: Change form baseline (0 week) to follow up (16 weeks)
Kidney Disease Quality of Life (KDQOL)
Time frame: Change form baseline (0 week) to follow up (16 weeks)
Modified Medical Research Council (mMRC)
Time frame: Change from baseline (0 week) to follow up (16 weeks)
Short Form-36 (SF-36)
Time frame: Change from baseline (0 week) to follow up (16 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 17 Dec 2025.
- 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.
Kun-Ling Tasi, PhD principal investigator
Department of Physical Therapy, National Cheng Kung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise, Blood flow restriction and Resistance 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 5 inclusion and 20 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 17 Dec 2025. 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 Tasi, PhD (886-6-2353535 Ext.5078, 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?
Diaphragm excursion and thickness (time frame: Change from baseline (0 week) to follow up (16 weeks)). The study lists 2 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 17 Dec 2025.