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Pulmonary Rehabilitation in Patients With Chronic Fibrotic Hypersensitivity Pneumonitis

Primary Purpose

Hypersensitivity Pneumonitis, Extrinsic Allergic Alveolitis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pulmonary Rehabilitation
Alternative Exercises
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hypersensitivity Pneumonitis focused on measuring Hypersensitivity Pneumonitis, Exercise Tolerance, Physical Activity, Muscle Strength

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    Training Group

    Control Group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.
    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
    Oxygen consumption
    Oxygen consumption will be measured by cardiopulmonary exercise test.

    Secondary Outcome Measures

    FEV1
    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
    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
    FEV1/FVC
    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
    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
    FEF2575
    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
    Maximal inspiratory and expiratory muscle strength will be evaluated using mouth pressure device .
    Inspiratory muscle endurance
    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
    Upper extremity muscle strength will be evaluated using portable hand held dynamometer.
    Peripheral muscle strength-lower extremity
    Knee extensor muscle strength will be evaluated using portable hand held dynamometer.
    Physical activity level
    Physical activity level will be evaluated multi sensor activity monitor for 3 consecutive days.
    Disease Specific Quality of Life
    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
    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
    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
    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
    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."

    Full Information

    First Posted
    September 13, 2020
    Last Updated
    September 22, 2020
    Sponsor
    Gazi University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04561479
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 1, 2021 (Anticipated)
    Primary Completion Date
    February 1, 2022 (Anticipated)
    Study Completion Date
    June 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Gazi University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypersensitivity Pneumonitis, Extrinsic Allergic Alveolitis
    Keywords
    Hypersensitivity Pneumonitis, Exercise Tolerance, Physical Activity, Muscle Strength

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Training Group
    Arm Type
    Active Comparator
    Arm Description
    Intervention:Training group will receive upper extremity aerobic exercise training, inspiratory muscle training and progressive resistance training
    Arm Title
    Control Group
    Arm Type
    Sham Comparator
    Arm Description
    Control group will receive alternative upper extremity exercises and breathing exercises.
    Intervention Type
    Other
    Intervention Name(s)
    Pulmonary Rehabilitation
    Intervention Description
    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)
    Intervention Type
    Other
    Intervention Name(s)
    Alternative Exercises
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Maximal exercise capacity
    Description
    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.
    Time Frame
    Second day
    Title
    Functional exercise capacity
    Description
    Functional exercise capacity will be evaluated with 6-minute walking test according to the American Thoracic Society and European Respratory Society criteria
    Time Frame
    First day
    Title
    Oxygen consumption
    Description
    Oxygen consumption will be measured by cardiopulmonary exercise test.
    Time Frame
    Second day
    Secondary Outcome Measure Information:
    Title
    FEV1
    Description
    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
    Time Frame
    First day
    Title
    FVC
    Description
    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
    Time Frame
    First day
    Title
    FEV1/FVC
    Description
    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.
    Time Frame
    First day
    Title
    PEF
    Description
    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
    Time Frame
    First day
    Title
    FEF2575
    Description
    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
    Time Frame
    First day
    Title
    Respiratory muscle strength
    Description
    Maximal inspiratory and expiratory muscle strength will be evaluated using mouth pressure device .
    Time Frame
    First day
    Title
    Inspiratory muscle endurance
    Description
    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.
    Time Frame
    First day
    Title
    Peripheral muscle strength-upper extremity
    Description
    Upper extremity muscle strength will be evaluated using portable hand held dynamometer.
    Time Frame
    First day
    Title
    Peripheral muscle strength-lower extremity
    Description
    Knee extensor muscle strength will be evaluated using portable hand held dynamometer.
    Time Frame
    First day
    Title
    Physical activity level
    Description
    Physical activity level will be evaluated multi sensor activity monitor for 3 consecutive days.
    Time Frame
    Three consecutive day
    Title
    Disease Specific Quality of Life
    Description
    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.
    Time Frame
    Second day
    Title
    Fatigue
    Description
    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.
    Time Frame
    Second day
    Title
    Dyspnea during daily living activities
    Description
    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.
    Time Frame
    Second day
    Title
    Anxiety
    Description
    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."
    Time Frame
    Second day
    Title
    Depression
    Description
    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."
    Time Frame
    Second day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zeliha ÇELİK, MSc
    Phone
    +903122162647
    Email
    zelihacelik@gazi.edu.tr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Meral BOŞNAK GÜÇLÜ, Prof
    Phone
    +903122162647
    Email
    meralbosnak@gazi.edu.tr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zeliha ÇELİK, MSc
    Organizational Affiliation
    Gazi University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Betül YOLERİ, PT
    Organizational Affiliation
    Gazi University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Meral BOŞNAK GÜÇLÜ, Prof
    Organizational Affiliation
    Gazi University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Haluk TÜRKTAŞ, Prof
    Organizational Affiliation
    Gazi University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30151370
    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.
    Results Reference
    background
    PubMed Identifier
    28213592
    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.
    Results Reference
    background
    PubMed Identifier
    25284270
    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.
    Results Reference
    background

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    Pulmonary Rehabilitation in Patients With Chronic Fibrotic Hypersensitivity Pneumonitis

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