The Effects of Combining Manual Soft Tissue Release and Physical Exercise Training on Lung Function(LF), Exercise Capacity(EC), and Cardiac Autonomic Function(CAF) in Moderate to Severe COPD: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- FEV1/FVC ratio
研究概览
简要总结
The potential effects of combining manual soft tissue release and physical exercise training on lung function, exercise capacity, and cardiac autonomic function in patients with moderate and severe chronic obstructive pulmonary disease were investigated.
详细描述
Chronic obstructive pulmonary disease (COPD) commonly presents with accessory respiratory muscle tightness and weakness, affecting chest wall compliance and lung elasticity. However, traditional physical therapy interventions, including pursed-lip breathing, sputum clearance techniques, and respiratory muscle training, are often used in treatment guidelines, with few studies focusing on muscle release for the accessory respiratory muscles. Although the effects of manual therapy on lung function and chest tightness in COPD have been demonstrated, the effects of soft tissue release combined with exercise intervention on COPD, including lung function, exercise capacity, and cardiac autonomic function, remain unknown. Therefore, this study proposes a randomized controlled trial to investigate the effects of manual soft tissue release combined with exercise training on lung function, exercise capacity, and cardiac autonomic function in patients with COPD. It is expected that the results of this study will demonstrate that combining manual soft tissue release with exercise training may increase gas exchange in the lungs, reduce respiratory effort, improve co-morbidities, delay disease progression, and enhance patient quality of life and clinical intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •GOLD grade II~IV
- •Stable condition
- •No acute exacerbations in 6 weeks
排除标准
- •Acute heart failure and, or arrhythmia
- •Pulmonary arterial hypertension
- •Skeletal and, or neuromuscular disorders
- •Chest surgery
- •Untreated or uncontrolled conditions
- •Rheumatoid conditions
- •Depends on oxygen supply
研究组 & 干预措施
Intervention group
The intervention group will receive combining manual soft tissue release and exercise training.
干预措施: Manual soft tissue release (Behavioral)
Intervention group
The intervention group will receive combining manual soft tissue release and exercise training.
干预措施: Exercise training (Behavioral)
Control group
The control group will receive combining myofascial release and exercise training.
干预措施: Myofascial release (Behavioral)
Control group
The control group will receive combining myofascial release and exercise training.
干预措施: Exercise training (Behavioral)
结局指标
主要结局
FEV1/FVC ratio
时间窗: Change from baseline (0 week) to follow-up (12 weeks)
FEV1/FVC ratio is measured by the lung function test, and the unit presented will be in percent.
expiratory reserve volume (ERV)
时间窗: Change from baseline (0 week) to follow-up (12 weeks)
ERV is measured by the lung function test, and the unit presented will be in liter.
residual volume (RV)
时间窗: Change from baseline (0 week) to follow-up (12 weeks)
RV is measured by the lung function test, and the unit presented will be in liters.
inspiratory reserve volume (IRV),
时间窗: Change from baseline (0 week) to follow-up (12 weeks)
IRV is measured by the lung functions test, and the unit presented will be in liters.
forced vital capacity (FVC)
时间窗: Change from baseline (0 week) to follow-up (12 weeks)
FVC is measured by the lung function test, and the unit presented will be in percent and liter.
inspiratory capacity (IC)
时间窗: Change from baseline (0 week) to follow-up (12 weeks)
IC is measured by the lung functions test, and the unit presented will be in liters.
tidal volume (TV)
时间窗: Change from baseline (0 week) to follow-up (12 weeks)
TV is measured by the lung function test, and the unit presented will be in liters.
functional residual capacity (FRC)
时间窗: Change from baseline (0 week) to follow-up (12 weeks)
FRC is measured by the lung functions test, and the unit presented will be in liters.
total lung capacity (TLC)
时间窗: Change from baseline (0 week) to follow-up (12 weeks)
TLC is measured by the lung function test, and the unit presented will be in liters.
vital capacity (VC)
时间窗: Change from baseline (0 week) to follow-up (12 weeks)
VC is measured by the lung function test, and the unit presented will be in liters.
Forced expiratory volume in 1 s (FEV1)
时间窗: Change from baseline (0 week) to follow-up (12 weeks)
FEV1 is measured by the lung function test, and the unit presented will be in percent and liter.
次要结局
- Diaphragmatic mobility(Change from baseline (0 week) to follow-up (12 weeks))
- six minute walk test (6-MWT)(Change from baseline (0 week) to follow-up (12 weeks))
- fatigue severity scale (FSS)(Change from baseline (0 week) to follow-up (12 weeks))
- Oxygen consumption (VO2)(Change from baseline (0 week) to follow-up (12 weeks))
- heart rate (HR)(Change from baseline (0 week) to follow-up (12 weeks))
- blood pressure (BP)(Change from baseline (0 week) to follow-up (12 weeks))
- oxygen saturation(Change from baseline (0 week) to follow-up (12 weeks))
- Cardiac Autonomic Function(Change from baseline (0 week) to follow-up (12 weeks))
- Modified Medical Research Council (mMRC)(Change from baseline (0 week) to follow-up (12 weeks))
- 36-Item Short Form Health Survey (SF-36)(Change from baseline (0 week) to follow-up (12 weeks))
- maximal inspiratory pressure (MIP)(Change from baseline (0 week) to follow-up (12 weeks))
- St. George's Respiratory Questionnaire (SGRQ)(Change from baseline (0 week) to follow-up (12 weeks))
- Rate of perceived exertion (RPE)(Change from baseline (0 week) to follow-up (12 weeks))
- maximal expiratory pressure (MEP)(Change from baseline (0 week) to follow-up (12 weeks))
研究者
Kun-Ling Tsai
Professor
National Cheng Kung University