Evaluation of the Effects of Pulmonary Rehabilitation in Patients With Chronic Fibrotic Hypersensitivity Pneumonitis
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- Maximal exercise capacity
研究概览
简要总结
The aim is to evaluate exercise capacity, respiratory functions, respiratory and peripheral muscle strength, inspiratory muscle endurance, physical activity level, quality of life, fatigue, dyspnea, anxiety, depression and investigate the impact of 24-session pulmonary rehabilitation training on these parameters in patients with chronic fibrotic hypersensitivity pneumonitis.
详细描述
Hypersensitivity pneumonitis is a syndrome that results in the excessive immune response to inhalation of various antigenic particles in the environment. Patients often experience irreversible physiological disorders and severe dyspnea in the future. Common disorders in these patients are lung function abnormalities, decreased exercise capacity, muscle weakness, oxygen diffusion limitation, impaired quality of life, physical inactivity and fatigue. The aim of this study is to evaluate the effects of pulmonary rehabilitation training on exercise capacity, dyspnea, respiratory functions, respiratory and peripheral muscle strength, inspiratory muscle endurance, physical activity level, quality of life, fatigue, dyspnea, anxiety, depression in patients with chronic fibrotic hypersensitivity pneumonitis. The study was planned as a prospective, double-blind, case-control study. At least 30 patients with hypersensitivity pneumonitis will be included in the study. The cardiopulmonary rehabilitation program will be included inspiratory muscle training, upper extremity aerobic exercise and progressive resistance training will be performed in the exercise training group during 24 sessions. Alternative upper extremity exercises combined with breathing exercises will be performed in the control group. Functional exercise capacity, respiratory functions, respiratory and peripheral muscle strength, inspiratory muscle endurance, physical activity levels, quality of life, fatigue, dyspnea, anxiety and depressions will be evaluated before and after treatment.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinically stable
- •Under standard medication
- •18-80 years of age
- •Patients diagnosed with chronic fibrotic hypersensitivity pneumonitis
排除标准
- •Having another diagnosed respiratory or cardiac problem
- •Orthopedic, or neurological psychiatric diseases with a potential to affect functional capacity,
- •Having a skeletal-muscular disease that may affect evaluation results
- •Uncontrolled asthma, MI (myocardial infarction) in the last 4 weeks, unstable AP (angina pectoris), 2-
- •degree block, rapid ventricular or atrial arrhythmias, ventricular aneurysm, acute systemic disorders (ARF (acute renal failure), thyrotoxicosis, infection), cooperation problem, severe aortic stenosis, dissecting aneurysm, uncontrolled CHF (chronic heart failure), uncontrolled hypertension ventricular aneurysm, severe pulmonary hypertension, thrombophlebitis / intracardiac thrombus, recent systemic/pulmonary embolism, acute pericarditis, endocarditis, myocarditis
- •Cognitive disorders
- •Patients who have contraindications for exercise testing.
结局指标
主要结局
Maximal exercise capacity
时间窗: Second day
Maximal exercise capacity will be evaluated symptom limited cardiopulmonary exercise testing. The cardiopulmonary exercise test will be performed on the treadmill at a progressively increasing speed and grade.
Functional exercise capacity
时间窗: First day
Functional exercise capacity will be evaluated with 6-minute walking test according to the American Thoracic Society and European Respratory Society criteria
Oxygen consumption
时间窗: Second day
Oxygen consumption will be measured by cardiopulmonary exercise test.
次要结局
- FEV1/FVC(First day)
- PEF(First day)
- FEV1(First day)
- FVC(First day)
- Fatigue(Second day)
- FEF2575(First day)
- Peripheral muscle strength-upper extremity(First day)
- Respiratory muscle strength(First day)
- Inspiratory muscle endurance(First day)
- Peripheral muscle strength-lower extremity(First day)
- Physical activity level(Three consecutive day)
- Disease Specific Quality of Life(Second day)
- Dyspnea during daily living activities(Second day)
- Depression(Second day)
- Anxiety(Second day)
研究者
Zeliha ÇELİK
Principal Investigator
Gazi University