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

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

Overview

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.

Interventions

• Behavioral Aerobic exercise
  The aerobic exercise intervention will utilize stationary bike. The program will be conducted 2 times per week over a 12 weeks
• Behavioral Blood flow restriction
  Blood flow restriction intervention will combined aerobic exercise and resistance exercise. The program will be conducted 2 times per week over a 12 weeks
• Behavioral Resistance exercise
  The resistance exercise will bilateral leg extension. The program will be conducted 2 times per week over a 12 weeks
• Behavioral Disease and exercise suggestion
  The participants will received self-care technique and home-based exercise approach

Primary outcome measures

• Diaphragm excursion and thickness [Time frame: Change from baseline (0 week) to follow up (16 weeks)]
• Exercise capacity [Time frame: Change form baseline (0 week) to follow up (16 weeks)]

Secondary outcome measures (12)

• 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)]

Eligibility 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

Taiwan · 1 center

• National Cheng Kung University Hospital — Tainan

Identifiers

NCT: NCT07288905 · B-ER-113-450

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗