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

National Cheng Kung University120 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

120

Conditions

Chronic Kidney Disease

Interventions

Aerobic exerciseBEHAVIORAL

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

Blood flow restrictionBEHAVIORAL

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 exerciseBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

National Cheng Kung University Hospital

Tainan, Taiwan

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 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

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

Secondary Outcomes

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

Time frame: 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

Time frame: 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.

Time frame: 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.

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