Pulmonary Rehabilitation in Patients With Chronic Fibrotic Hypersensitivity Pneumonitis

NCT04561479 | Unknown

• 1 other identifier: 283
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypersensitivity Pneumonitis; Extrinsic Allergic Alveolitis

Keywords

Hypersensitivity Pneumonitis; Exercise Tolerance; Physical Activity; Muscle Strength

Outcome Measures

Primary Outcomes (3)

• Maximal exercise capacity

  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.

  Second day

• Functional exercise capacity

  Functional exercise capacity will be evaluated with 6-minute walking test according to the American Thoracic Society and European Respratory Society criteria

  First day

• Oxygen consumption

  Oxygen consumption will be measured by cardiopulmonary exercise test.

  Second day

Secondary Outcomes (15)

• FEV1

  First day

• FVC

  First day

• FEV1/FVC

  First day

• PEF

  First day

• FEF2575

  First day

Study Arms (2)

Training Group

ACTIVE COMPARATOR

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

Other: Pulmonary Rehabilitation

Control Group

SHAM COMPARATOR

Control group will receive alternative upper extremity exercises and breathing exercises.

Other: Alternative Exercises

Interventions

Pulmonary Rehabilitation OTHER

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)

Training Group

Alternative Exercises OTHER

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

Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically stable
• Under standard medication
• years of age
• Patients diagnosed with chronic fibrotic hypersensitivity pneumonitis

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gazi University: lead

Related Publications (3)

• 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.

  PMID: 30151370 BACKGROUND

• 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.

  PMID: 28213592 BACKGROUND

• 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.

  PMID: 25284270 BACKGROUND

MeSH Terms

Conditions

Alveolitis, Extrinsic Allergic; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Behavior

Study Officials

• Zeliha ÇELİK, MSc

  Gazi University

  PRINCIPAL INVESTIGATOR

• Betül YOLERİ, PT

  Gazi University

  PRINCIPAL INVESTIGATOR

• Meral BOŞNAK GÜÇLÜ, Prof

  Gazi University

  STUDY DIRECTOR

• Haluk TÜRKTAŞ, Prof

  Gazi University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zeliha ÇELİK, MSc

CONTACT

+903122162647; zelihacelik@gazi.edu.tr

Meral BOŞNAK GÜÇLÜ, Prof

CONTACT

+903122162647; meralbosnak@gazi.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 13, 2020
• First Posted: September 23, 2020
• Study Start: June 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: June 1, 2023
• Last Updated: September 23, 2020

Record last verified: 2020-09