Pulmonary Rehabilitation in Patients With Chronic Fibrotic Hypersensitivity Pneumonitis

Brief Title

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

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.
    


Study Type

Interventional


Primary Outcome

Maximal exercise capacity

Secondary Outcome

 FEV1

Condition

Hypersensitivity Pneumonitis

Intervention

Pulmonary Rehabilitation

Study Arms / Comparison Groups

 Training Group
Description:  Intervention:Training group will receive upper extremity aerobic exercise training, inspiratory muscle training and progressive resistance training

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

30

Start Date

June 1, 2021

Completion Date

June 1, 2023

Primary Completion Date

February 1, 2022

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.
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Zeliha ÇELİK, MSc, +903122162647, [email protected]



Administrative Informations


NCT ID

NCT04561479

Organization ID

283


Responsible Party

Principal Investigator

Study Sponsor

Gazi University


Study Sponsor

Zeliha ÇELİK, MSc, Principal Investigator, Gazi University


Verification Date

September 2020