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

National Cheng Kung University

Status: Enrolling

Conditions: Chronic Kidney Disease

Treatments: Behavioral: Blood flow restriction; Behavioral: Resistance exercise; Behavioral: Aerobic exercise; Behavioral: Disease and exercise suggestion

Study type: Interventional

Funder types: Other

Identifiers

NCT07288905

B-ER-113-450

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 20 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 4 patient groups

healthy

Experimental group

Description:

We will provide BFR combined with exercise

Treatment:

Behavioral: Disease and exercise suggestion

Behavioral: Aerobic exercise

Behavioral: Resistance exercise

Behavioral: Blood flow restriction

CKD usual care group

Active Comparator group

Description:

We will provide patient education, home-based moderate to low-intensity rehabilitation

Treatment:

Behavioral: Disease and exercise suggestion

CKD traditional rehabilitation group

Active Comparator group

Description:

We will provide aerobic exercise, resistance exercise training, and patient education

Treatment:

Behavioral: Disease and exercise suggestion

Behavioral: Aerobic exercise

Behavioral: Resistance exercise

CKD BFR group

Experimental group

Description:

We will provide BFR combined with exercise and patient education

Treatment:

Behavioral: Aerobic exercise

Behavioral: Resistance exercise

Behavioral: Blood flow restriction