Pulmonary Rehabilitation in Patients With Chronic Fibrotic Hypersensitivity Pneumonitis
- Conditions
- Hypersensitivity PneumonitisExtrinsic Allergic Alveolitis
- Interventions
- Other: Pulmonary RehabilitationOther: Alternative Exercises
- Registration Number
- NCT04561479
- Lead Sponsor
- Gazi University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- Clinically stable
- Under standard medication
- 18-80 years of age
- Patients diagnosed with chronic fibrotic hypersensitivity pneumonitis
- 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), 2-3. 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Training Group Pulmonary Rehabilitation Intervention:Training group will receive upper extremity aerobic exercise training, inspiratory muscle training and progressive resistance training Control Group Alternative Exercises Control group will receive alternative upper extremity exercises and breathing exercises.
- Primary Outcome Measures
Name Time Method Maximal exercise capacity 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 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 Second day Oxygen consumption will be measured by cardiopulmonary exercise test.
- Secondary Outcome Measures
Name Time Method FEV1/FVC First day Pulmonary function tests will be performed using a spirometry according to the American Thoracic Society and European Respratory Society criteria. FEV1/FVC will be evaluated.
PEF First day Pulmonary function tests will be performed using a spirometry according to the American Thoracic Society and European Respratory Society criteria. PEF will be evaluated. The percentage of predicted value \<70% will be expressed as abnormal
FEV1 First day Pulmonary function tests will be performed using a spirometry according to the American Thoracic Society and European Respratory Society criteria. FEV1 will be evaluated. The percentage of predicted value \<70% will be expressed as abnormal
FVC First day Pulmonary function tests will be performed using a spirometry according to the American Thoracic Society and European Respratory Society criteria. FVC will be evaluated. The percentage of predicted value \<70% will be expressed as abnormal
Fatigue Second day Fatigue using Fatigue Severity Scale (Turkish version) will be evaluated. The scale comprises nine statements.The scale of possible responses are ranging from 1 (strongly disagree) to 7 (strongly agree). FSS total scores are usually reported as the mean score over the nine items; a higher score indicates greater severity.
FEF2575 First day Pulmonary function tests will be performed using a spirometry according to the American Thoracic Society and European Respratory Society criteria. FEF2575 will be evaluated. The percentage of predicted value \<50% will be expressed as abnormal
Respiratory muscle strength First day Maximal inspiratory and expiratory muscle strength will be evaluated using mouth pressure device .
Inspiratory muscle endurance First day It will be evaluated incremental threshold loading test, in which participants started an initial load of 30% of maximal inspiratory pressure with a 10% increment every 2 minutes.
Peripheral muscle strength-upper extremity First day Upper extremity muscle strength will be evaluated using portable hand held dynamometer.
Peripheral muscle strength-lower extremity First day Knee extensor muscle strength will be evaluated using portable hand held dynamometer.
Physical activity level Three consecutive day Physical activity level will be evaluated multi sensor activity monitor for 3 consecutive days.
Disease Specific Quality of Life Second day Quality of Life using St. George's Respiratory Questionnaire (SGRQ) will be evaluated. Scores range from 0 to 100, with higher scores indicating more limitations.
Dyspnea during daily living activities Second day Dyspnea using Modified Medical Research Council (MMRC) dyspnea scale will be evaluated. Modified Medical Research Council Dyspnea Scale, levels are graded as 0-4, higher scores imply higher dyspnea.
Depression Second day Depression using Hospital Anxiety and Depression Scale will be evaluated. HADS consists of two subscales including anxiety and depression. Possible scores are ranged from 0 to 21 for each of the two subscales. The HADS manual indicates that a score between 0 and 7 is "normal," between 8 and 10 "mild," between 11 and 14 "moderate," and between 15 and 21 "severe."
Anxiety Second day Anxiety using Hospital Anxiety and Depression Scale will be evaluated. HADS consists of two subscales including anxiety and depression. Possible scores are ranged from 0 to 21 for each of the two subscales. The HADS manual indicates that a score between 0 and 7 is "normal," between 8 and 10 "mild," between 11 and 14 "moderate," and between 15 and 21 "severe."