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
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
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
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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