National Cheng Kung University Hospital
Tainan, 701, Taiwan
Location status: Recruiting
NCT Number: NCT07288905
Investigate the effects of exercise training on the cardiopulmonary function and exercise capacity in healthy and CKD patients
Interested in participating?
Request Info20 year–85 year
All sexes
Interventional
Not applicable
Tainan, 701, Taiwan
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Healthy
Inclusion criteria
Exclusion criteria
CKD
Inclusion criteria
Exclusion criteria
The aerobic exercise intervention will utilize stationary bike. The program will be conducted 2 times per week over a 12 weeks
Blood flow restriction intervention will combined aerobic exercise and resistance exercise. The program will be conducted 2 times per week over a 12 weeks
The resistance exercise will bilateral leg extension. The program will be conducted 2 times per week over a 12 weeks
The participants will received self-care technique and home-based exercise approach
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
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
Time frame: Change form baseline (0 week) to follow up (16 weeks)
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
Time frame: Change form baseline (0 week) to follow up (16 weeks)
Root Mean Square of Successive Differences (RMSSD in ms) represents short-term HRV and parasympathetic activity
Time frame: Change form baseline (0 week) to follow up (16 weeks)
Low frequency power (LF, in ms²) reflects both sympathetic and parasympathetic modulation.
Time frame: Change from baseline (0 week) to follow-up (16 weeks)
High frequency power (HF in ms²) reflects parasympathetic (vagal) activity.
Time frame: Change from baseline (0 week) to follow-up (16 weeks)
LF/HF ratio represents sympathovagal balance.
Time frame: Change from baseline (0 week) to follow up (16 weeks)
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.
Time frame: Change from baseline (0 week) to follow up (16 weeks)
Functional capacity is examined by 6 minute walking test (6MWT, in m)
Time frame: Change from baseline (0 week) to follow up (16 weeks)
Functional ability is examined using the Timed Up and Go (TUG) test, where the time taken (in seconds) to complete the test is recorded.
Time frame: Change from baseline (0 week) to follow up (16 weeks)
Flexibility is examined by the sit and reach test (unit: cm).
Time frame: Change from baseline (0 week) to follow-up (16 weeks)
Maximal voluntary handgrip strength. (unit: N)
Time frame: Change from baseline (0 week) to follow up (16 weeks)
Maximal voluntary contraction of upper limb muscles. (unit: N)
Time frame: Change from baseline (0 week) to follow up (16 weeks)
Maximal voluntary contraction of neck muscles. (unit: N)
Time frame: Change from baseline (0 week) to follow-up (16 weeks)
Maximal voluntary contraction of the knee extensor muscles. (unit: N)
Time frame: Change from baseline (0 week) to follow up (20 weeks)
Maximum respiratory pressure is measured using a manometer, which records both maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP), in cmH₂O.
Time frame: Change form baseline (0 week) to follow up (16 weeks)
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.
Time frame: Change form baseline (0 week) to follow up (16 weeks)
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.
Time frame: Change from baseline (0 week) to follow up (16 weeks)
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.
Time frame: Change from baseline (0 week) to follow up (16 weeks)
The Short Form-36 (SF-36) measures physical and social health status, with higher scores representing better overall health
Contact information is provided by the study sponsor or research team.
Kun-Ling Tasi, PhD
CONTACT
886-6-2353535 Ext.5078
Ting-Ying Wu, B.S
CONTACT
886-6-2353535 Ext.5078
National Cheng Kung University
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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