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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (12)

• Heart rate variability (Standard Deviation of Normal-to-Normal Intervals, SDNN) [Срок оценки: Change form baseline (0 week) to follow up (16 weeks)]
• Heart rate variability (Root Mean Square of Successive Differences, RMSSD) [Срок оценки: Change form baseline (0 week) to follow up (16 weeks)]
• Heart rate variability (Low Frequency power, LF) [Срок оценки: Change form baseline (0 week) to follow up (16 weeks)]
• Heart rate variability (High Frequency power, HF) [Срок оценки: Change from baseline (0 week) to follow-up (16 weeks)]
• Heart rate variability (LF/HF Ratio) [Срок оценки: Change from baseline (0 week) to follow-up (16 weeks)]
• Pulmonary function test [Срок оценки: Change from baseline (0 week) to follow up (16 weeks)]
• Functional capacity [Срок оценки: Change from baseline (0 week) to follow up (16 weeks)]
• Functional ability [Срок оценки: Change from baseline (0 week) to follow up (16 weeks)]
• Sit-and-Reach Test [Срок оценки: Change from baseline (0 week) to follow up (16 weeks)]
• Handgrip Strength [Срок оценки: Change from baseline (0 week) to follow-up (16 weeks)]
• Upper Limb Muscle Strength [Срок оценки: Change from baseline (0 week) to follow up (16 weeks)]
• Neck Muscle Strength [Срок оценки: Change from baseline (0 week) to follow up (16 weeks)]

Критерии участия

Healthy

Критерии включения

• Aged 20\~85 years old

Критерии исключения

• 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

Критерии включения

• 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

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Тайвань · 1 центр

• National Cheng Kung University Hospital — Tainan

Идентификаторы

NCT: NCT07288905 · B-ER-113-450

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗