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NCT Number: NCT07288905

Exploring the Effects of Exercise Combined With BFRT on Healthy and Patients With CKD

Investigate the effects of exercise training on the cardiopulmonary function and exercise capacity in healthy and CKD patients

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Key information

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng Kung University Hospital

Tainan, 701, Taiwan

Location status: Recruiting

Location contact

Kun-Ling Tasi, PhD

CONTACT

[email protected]

062353535 Ext. 6219

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Healthy

Inclusion criteria

  • Aged 20~85 years old

Exclusion criteria

  • 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
  • Recent inflection < 1 month
  • Pregnancy
  • Kidney function impairment
  • Cancer
  • Simultaneously participating in other research

CKD

Inclusion criteria

  • 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

Exclusion criteria

  • 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).

Treatment and study plan

Aerobic Exercise

Behavioral

The aerobic exercise intervention will utilize stationary bike. The program will be conducted 2 times per week over a 12 weeks

Blood Flow Restriction

Behavioral

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 exercise

Behavioral

The resistance exercise will bilateral leg extension. The program will be conducted 2 times per week over a 12 weeks

Disease and exercise suggestion

Behavioral

The participants will received self-care technique and home-based exercise approach

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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 (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

  2. Heart rate variability (Root Mean Square of Successive Differences, RMSSD)

    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

  3. Heart rate variability (Low Frequency power, LF)

    Time frame: Change form baseline (0 week) to follow up (16 weeks)

    Low frequency power (LF, in ms²) reflects both sympathetic and parasympathetic modulation.

  4. Heart rate variability (High Frequency power, HF)

    Time frame: Change from baseline (0 week) to follow-up (16 weeks)

    High frequency power (HF in ms²) reflects parasympathetic (vagal) activity.

  5. Heart rate variability (LF/HF Ratio)

    Time frame: Change from baseline (0 week) to follow-up (16 weeks)

    LF/HF ratio represents sympathovagal balance.

  6. Pulmonary function test

    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.

  7. Functional capacity

    Time frame: Change from baseline (0 week) to follow up (16 weeks)

    Functional capacity is examined by 6 minute walking test (6MWT, in m)

  8. Functional ability

    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.

  9. Sit-and-Reach Test

    Time frame: Change from baseline (0 week) to follow up (16 weeks)

    Flexibility is examined by the sit and reach test (unit: cm).

  10. Handgrip Strength

    Time frame: Change from baseline (0 week) to follow-up (16 weeks)

    Maximal voluntary handgrip strength. (unit: N)

  11. Upper Limb Muscle Strength

    Time frame: Change from baseline (0 week) to follow up (16 weeks)

    Maximal voluntary contraction of upper limb muscles. (unit: N)

  12. Neck Muscle Strength

    Time frame: Change from baseline (0 week) to follow up (16 weeks)

    Maximal voluntary contraction of neck muscles. (unit: N)

  13. Knee Extensor Strength

    Time frame: Change from baseline (0 week) to follow-up (16 weeks)

    Maximal voluntary contraction of the knee extensor muscles. (unit: N)

  14. Maximum respiratory pressure

    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.

  15. Fatigue Severity Scale (FSS)

    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.

  16. Kidney Disease Quality of Life (KDQOL)

    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.

  17. Modified Medical Research Council (mMRC)

    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.

  18. Short Form-36 (SF-36)

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Kun-Ling Tasi, PhD

CONTACT

[email protected]

886-6-2353535 Ext.5078

Ting-Ying Wu, B.S

CONTACT

[email protected]

886-6-2353535 Ext.5078

Sponsors and collaborators

Lead sponsor

National Cheng Kung University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2030
First posted
Dec 17, 2025
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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