Clinical trial NCT04561479: Pulmonary Rehabilitation in Patients With Chronic Fibrotic Hypersensitivity Pneumonitis
Official title: Evaluation of the Effects of Pulmonary Rehabilitation in Patients With Chronic Fibrotic Hypersensitivity Pneumonitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypersensitivity Pneumonitis
Extrinsic Allergic Alveolitis
Keywords: Hypersensitivity Pneumonitis
Exercise Tolerance
Physical Activity
Muscle Strength
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2020-09-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Maximal exercise capacity
timeFrame: Second day
measure: Functional exercise capacity
timeFrame: First day
measure: Oxygen consumption
timeFrame: Second day
Secondary outcomes:
measure: FEV1
timeFrame: First day
measure: FVC
timeFrame: First day
measure: FEV1/FVC
timeFrame: First day
measure: PEF
timeFrame: First day
measure: FEF2575
timeFrame: First day
measure: Respiratory muscle strength
timeFrame: First day
measure: Inspiratory muscle endurance
timeFrame: First day
measure: Peripheral muscle strength-upper extremity
timeFrame: First day
measure: Peripheral muscle strength-lower extremity
timeFrame: First day
measure: Physical activity level
timeFrame: Three consecutive day
measure: Disease Specific Quality of Life
timeFrame: Second day
measure: Fatigue
timeFrame: Second day
measure: Dyspnea during daily living activities
timeFrame: Second day
measure: Anxiety
timeFrame: Second day
measure: Depression
timeFrame: Second day
Other outcomes:
Locations:
Study officials:
affiliation: Gazi University
name: Zeliha ÇELİK, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Betül YOLERİ, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Meral BOŞNAK GÜÇLÜ, Prof
role: STUDY_DIRECTOR
affiliation: Gazi University
name: Haluk TÜRKTAŞ, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dias OM, Baldi BG, Ferreira JG, Cardenas LZ, Pennati F, Salito C, Carvalho CRR, Aliverti A, Pereira de Albuquerque AL. Mechanisms of exercise limitation in patients with chronic hypersensitivity pneumonitis. ERJ Open Res. 2018 Aug 22;4(3):00043-2018. doi: 10.1183/23120541.00043-2018. eCollection 2018 Jul.
citation: Dowman LM, McDonald CF, Hill CJ, Lee AL, Barker K, Boote C, Glaspole I, Goh NSL, Southcott AM, Burge AT, Gillies R, Martin A, Holland AE. The evidence of benefits of exercise training in interstitial lung disease: a randomised controlled trial. Thorax. 2017 Jul;72(7):610-619. doi: 10.1136/thoraxjnl-2016-208638. Epub 2017 Feb 17.
citation: Dowman L, Hill CJ, Holland AE. Pulmonary rehabilitation for interstitial lung disease. Cochrane Database Syst Rev. 2014 Oct 6;(10):CD006322. doi: 10.1002/14651858.CD006322.pub3.