Extrinsic Allergic Alveolitis, Hypersensitivity Pneumonitis
Conditions
Keywords
Hypersensitivity Pneumonitis, Exercise Tolerance, Physical Activity, Muscle Strength
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.
Interventions
OTHERPulmonary Rehabilitation
All exercise program will be applied during supervised session by a physiotherapist. Range of maximal heart rate will be screened by heart rate monitor during supervised session. Training group will receive upper extremity aerobic exercise training using arm ergometer at 60-80% of maximal heart rate (dyspnea perception at 3-4 level as well as fatigue perception at 5-6 level according to Modified Borg Scale). Inspiratory muscle training (Powerbreathe® Wellness-Inspiratory Muscle Trainer) at 50-60% of maximal inspiratory pressure (MIP) and progressive resistance training at 30-60% of 1 RM (using proprioceptive neuromuscular facilitation techniques (flexion, abduction, external rotation/extension, adduction, internal rotation) for upper extremity resistance training; using sandback for knee extensors) will be performed during 24 sessions (3 day/week; 8 weeks)
OTHERAlternative Exercises
Control group will receive alternative upper extremity exercises combined with breathing exercises. Control group will perform alternative upper extremity exercises combined with breathing exercises during 3 days/week, for 8 weeks
Sponsors
Gazi University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Clinically stable * Under standard medication * 18-80 years of age * Patients diagnosed with chronic fibrotic hypersensitivity pneumonitis
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Physical activity level | Three consecutive day | Physical activity level will be evaluated multi sensor activity monitor for 3 consecutive days. |
| 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 |
Contacts
Primary ContactZeliha ÇELİK, MSc
Backup ContactMeral BOŞNAK GÜÇLÜ, Prof
Outcome results
None listed