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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Diaphragm excursion and thickness
研究概览
简要总结
Investigate the effects of exercise training on the cardiopulmonary function and exercise capacity in healthy and CKD patients
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria:
- •Aged 20~85 years old
排除标准
- •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
- •Simultaneously participating in other research
- •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).
结局指标
主要结局
Diaphragm excursion and thickness
时间窗: 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
Exercise capacity
时间窗: 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
次要结局
- Handgrip Strength(Change from baseline (0 week) to follow-up (16 weeks))
- Heart rate variability (Standard Deviation of Normal-to-Normal Intervals, SDNN)(Change form baseline (0 week) to follow up (16 weeks))
- Heart rate variability (Root Mean Square of Successive Differences, RMSSD)(Change form baseline (0 week) to follow up (16 weeks))
- Heart rate variability (Low Frequency power, LF)(Change form baseline (0 week) to follow up (16 weeks))
- Heart rate variability (High Frequency power, HF)(Change from baseline (0 week) to follow-up (16 weeks))
- Heart rate variability (LF/HF Ratio)(Change from baseline (0 week) to follow-up (16 weeks))
- Pulmonary function test(Change from baseline (0 week) to follow up (16 weeks))
- Functional capacity(Change from baseline (0 week) to follow up (16 weeks))
- Functional ability(Change from baseline (0 week) to follow up (16 weeks))
- Sit-and-Reach Test(Change from baseline (0 week) to follow up (16 weeks))
- Upper Limb Muscle Strength(Change from baseline (0 week) to follow up (16 weeks))
- Neck Muscle Strength(Change from baseline (0 week) to follow up (16 weeks))
- Knee Extensor Strength(Change from baseline (0 week) to follow-up (16 weeks))
- Maximum respiratory pressure(Change from baseline (0 week) to follow up (20 weeks))
- Fatigue Severity Scale (FSS)(Change form baseline (0 week) to follow up (16 weeks))
- Kidney Disease Quality of Life (KDQOL)(Change form baseline (0 week) to follow up (16 weeks))
- Modified Medical Research Council (mMRC)(Change from baseline (0 week) to follow up (16 weeks))
- Short Form-36 (SF-36)(Change from baseline (0 week) to follow up (16 weeks))
研究者
Kun-Ling Tsai
Professor and Chair, Department of Physical Therapy
National Cheng Kung University