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Effect of Respiratory Muscle Training in Interstitial Lung Patients

Primary Purpose

Interstitial Lung Disease

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Conventional Chest Physiotherapy
Inspiratory Muscle Training
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Interstitial Lung Disease focused on measuring Interstitial lung disease, Interstitial pulmonary fibrosis, Sarcoidosis, Respiratory muscle training, Pulmonary Function, Functional Capacity, Physiotherapy, Balance, Quality of Life, 6 Minute Walk Test

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Being diagnosed with interstitial lung disease (idiopathic pulmonary fibrosis, collagen vascular diseases, sarcoidosis, etc.),
  • Being clinically stable,
  • Not receiving supplemental oxygen therapy,
  • No pulmonary infection in the last 6 weeks,
  • Being ambulation.

Exclusion Criteria:

  • Presence of obstructive pulmonary disease such as chronic obstructive pulmonary disease (COPD), asthma, bronchiectasis
  • Presence of a history of effort-induced syncope
  • Presence of severe orthopedic or neurological disease
  • Presence of unstable serious cardiac disease

Sites / Locations

  • Bezmialem Vakif University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Inspiratory Muscle Training (IMT) Group

Arm Description

Patients in this group will receive conventional chest physiotherapy, two times a day, 5 days a week for 8 weeks. After the training given by the physiotherapist one exercise session will be supervised in a clinic per week, other sessions will be performed at home. Maximal inspiratory mouth pressure measurements will be measured once a week to eliminate the effect of learning, however the training intensity will remain at the lowest intensity of the device for 8 weeks and will not be increased.

In addition to conventional chest physiotherapy programme, patients in this group will also receive inspiratory muscle training at %30 of the maximal inspiratory mouth pressure (MIP) value of at least five days a week, for 15 minutes twice days, for 8 weeks at home. One exercise session will be supervised in a clinic per week, other sessions will be performed at home. Maximal inspiratory mouth pressure measurements will be measured once a week. The training intensity will be increased weekly. At this rate it is 30% of the maximal inspiratory pressure value.

Outcomes

Primary Outcome Measures

Respiratory Function Test / Forced Vital Capacity (FVC)
Change from baseline Forced Vital Capacity (FVC) in respiratory function test at 8 weeks. FVC will be evaluated using spirometry, according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Respiratory Function Test / Forced Expiratory Volume 1 second (FEV1)
Change from baseline Forced Expiratory Volume 1 second (FEV1) in respiratory function test at 8 weeks. FEV1 will be evaluated using spirometry, according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Respiratory Function Test / Peak Expiratory Flow (PEF)
Change from baseline Peak Expiratory Flow (PEF) in respiratory function test at 8 weeks. PEF will be evaluated using spirometry, according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Respiratory Function Test / Tiffeneau-Pinelli index (FEV1/FVC)
Change from baseline Tiffeneau-Pinelli index (Forced Expiratory Volume 1 second (FEV1) / Forced Vital Capacity (FVC)) in respiratory function test at 8 weeks. FEV1 / FVC will be evaluated using spirometry, according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Respiratory Muscle Strength / Maximum Inspiratory Pressure (MIP)
Change from baseline Maximum Inspiratory Pressure (MIP) at 8 weeks. Respiratory muscle strength will be measured according to the portable, electronic intraoral pressure measuring device (MicroRPM, Micro Medical UK), American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Respiratory Muscle Strength / Maximum Expiratory Pressure (MEP)
Change from baseline Maximum Expiratory Pressure (MEP) at 8 weeks. Respiratory muscle strength will be measured according to the portable, electronic intraoral pressure measuring device (MicroRPM, Micro Medical UK), American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Functional Capacity
Change from baseline distance covered in six-minute walk test at 8 weeks
Balance / Postural Stability
Change from baseline postural stability test score in Biodex Balance System at 8 weeks
Balance / Limits of Stability
Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks
Balance / Sensory Integration and Balance Test Score
Change from baseline sensory integration and balance test score in Biodex Balance System SD at 8 weeks

Secondary Outcome Measures

Peripheral Muscle Strength
Change from baseline M. Quadriceps strength at 8 weeks. It will be performed using an electronic hand dynamometer (Commander Muscle Tester; JTECH Medical, USA). M. Quadriceps muscle strength will be measured; it will evaluate the isometric muscle strength of that muscle by applying maximum resistance to the M. Quadriceps muscle with the electronic hand dynamometer.
Pain Level
Change from baseline Visual Analogue Scale (VAS) at 8 weeks.This scale consists of a horizontal, straight line. The line has a value of 0 at the beginning and a value of 10 at the end. A value of 0 means no pain, a value of 10 means unbearable pain. high values represent severe pain.
Dyspnea
Change from baseline Modified Medical Research Council Dyspnea Scale (mMRC) at 8 weeks. The Modified Medical Research Council Dyspnea Scale (mMRC) is a five-item scale based on various activities that cause breathlessness. The scale is rated from "0" to "4". High values indicate severe shortness of breath.
Health-Related Quality of Life
Change from baseline St. George's Respiratory Questionnaire (SGRQ) at 8 weeks. St. George's Respiratory Questionnaire consists of 76 questions that can be filled in about 15 minutes. It consists of 3 subgroups that evaluate respiratory symptoms (dyspnea, cough, sputum, wheezing, severity and frequency), activity status (physical functions that cause shortness of breath, housework, hobbies) and the impact of the disease (social activities and psychological state). The three parts of the test are scored separately and the total score is calculated. Scores range from 0-100. A score of zero indicates normal and a score of 100 indicates maximum disability.

Full Information

First Posted
October 13, 2021
Last Updated
October 30, 2021
Sponsor
Bezmialem Vakif University
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1. Study Identification

Unique Protocol Identification Number
NCT05106556
Brief Title
Effect of Respiratory Muscle Training in Interstitial Lung Patients
Official Title
The Effect of Respiratory Muscle Training on Respiratory Parameters, Functional Capacity, Balance and Quality of Life in Interstitial Lung Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 9, 2019 (Actual)
Primary Completion Date
January 3, 2022 (Anticipated)
Study Completion Date
January 31, 2022 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
The aim of this study is to investigate the possible effects of inspiratory muscle training (IMT) on respiratory functions, functional capacity, balance and quality of life in patients with interstitial lung disease.
Detailed Description
Interstitial lung disease (ILD) include a heterogeneous group of progressive, acute and chronic diseases that diffusely affect the lung and characterized by varying degrees of inflammation and fibrosis in the lung parenchyma. The disease group usually shows a restrictive pattern and progresses with gas exchange abnormalities. Progressive lung fibrosis was first described in 1935. Over the years, more than 150 lung disease characterized by acute or chronic pulmonary fibrosis of varying degrees with known or unknown cause have been defined and these diseases were named interstitial lung disease (ILD) in 1970s. Common symptoms in chronic interstitial lung diseases in general; dyspnea, dry cough, exercise intolerance and fatigue. All these features of interstitial lung diseases cause an increase in respiratory work and ventilatory deterioration in exercise. Apart from these general features, muscle weakness and related exercise intolerance may occur in some specific conditions. The most important factor limiting exercise capacity in these patients is circulatory disorder, which cause exercise induced deterioration in gas exchange. Hypoxemia induced exercise intolerance causes a decrease in health-related quality of life, limitation of functional capacity and inactivity in daily life. According to the American Thoracic Society (ATS) / European Respiratory Society (ERS) respiratory rehabilitation guideline, although the data are not conclusive, inspiratory muscle training is recommended as an adjunct to pulmonary rehabilitation, especially in patients with suspected or confirmed respiratory muscle weakness. The effect of well-structured and supervised inspiratory muscle training (IMT) on respiratory functions, diaphragm weakness, functional capacity, balance and quality of life in patients with interstitial lung disease is unknown. It is important that this research will be carried out in this area and because it has a current subject.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Lung Disease
Keywords
Interstitial lung disease, Interstitial pulmonary fibrosis, Sarcoidosis, Respiratory muscle training, Pulmonary Function, Functional Capacity, Physiotherapy, Balance, Quality of Life, 6 Minute Walk Test

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group 1: Inspiratory Muscle Training (IMT) Group Group 2: Control Group
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Patients in this group will receive conventional chest physiotherapy, two times a day, 5 days a week for 8 weeks. After the training given by the physiotherapist one exercise session will be supervised in a clinic per week, other sessions will be performed at home. Maximal inspiratory mouth pressure measurements will be measured once a week to eliminate the effect of learning, however the training intensity will remain at the lowest intensity of the device for 8 weeks and will not be increased.
Arm Title
Inspiratory Muscle Training (IMT) Group
Arm Type
Experimental
Arm Description
In addition to conventional chest physiotherapy programme, patients in this group will also receive inspiratory muscle training at %30 of the maximal inspiratory mouth pressure (MIP) value of at least five days a week, for 15 minutes twice days, for 8 weeks at home. One exercise session will be supervised in a clinic per week, other sessions will be performed at home. Maximal inspiratory mouth pressure measurements will be measured once a week. The training intensity will be increased weekly. At this rate it is 30% of the maximal inspiratory pressure value.
Intervention Type
Other
Intervention Name(s)
Conventional Chest Physiotherapy
Intervention Description
Programme will include diaphragmatic breathing exercise, pursed lip breathing exercise, thoracic expansion exercises, upper and lower extremity exercises, stretching the pectoral muscles, posture exercises, walking training and teaching respiratory control.
Intervention Type
Other
Intervention Name(s)
Inspiratory Muscle Training
Intervention Description
Threshold IMT device will be used for the training. Training intensity will set at 30% of the maximum inspiratory pressure with the threshold loading method.
Primary Outcome Measure Information:
Title
Respiratory Function Test / Forced Vital Capacity (FVC)
Description
Change from baseline Forced Vital Capacity (FVC) in respiratory function test at 8 weeks. FVC will be evaluated using spirometry, according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Time Frame
Eight weeks
Title
Respiratory Function Test / Forced Expiratory Volume 1 second (FEV1)
Description
Change from baseline Forced Expiratory Volume 1 second (FEV1) in respiratory function test at 8 weeks. FEV1 will be evaluated using spirometry, according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Time Frame
Eight weeks
Title
Respiratory Function Test / Peak Expiratory Flow (PEF)
Description
Change from baseline Peak Expiratory Flow (PEF) in respiratory function test at 8 weeks. PEF will be evaluated using spirometry, according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Time Frame
Eight weeks
Title
Respiratory Function Test / Tiffeneau-Pinelli index (FEV1/FVC)
Description
Change from baseline Tiffeneau-Pinelli index (Forced Expiratory Volume 1 second (FEV1) / Forced Vital Capacity (FVC)) in respiratory function test at 8 weeks. FEV1 / FVC will be evaluated using spirometry, according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Time Frame
Eight weeks
Title
Respiratory Muscle Strength / Maximum Inspiratory Pressure (MIP)
Description
Change from baseline Maximum Inspiratory Pressure (MIP) at 8 weeks. Respiratory muscle strength will be measured according to the portable, electronic intraoral pressure measuring device (MicroRPM, Micro Medical UK), American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Time Frame
Eight weeks
Title
Respiratory Muscle Strength / Maximum Expiratory Pressure (MEP)
Description
Change from baseline Maximum Expiratory Pressure (MEP) at 8 weeks. Respiratory muscle strength will be measured according to the portable, electronic intraoral pressure measuring device (MicroRPM, Micro Medical UK), American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Time Frame
Eight weeks
Title
Functional Capacity
Description
Change from baseline distance covered in six-minute walk test at 8 weeks
Time Frame
Eight weeks
Title
Balance / Postural Stability
Description
Change from baseline postural stability test score in Biodex Balance System at 8 weeks
Time Frame
Eight weeks
Title
Balance / Limits of Stability
Description
Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks
Time Frame
Eight weeks
Title
Balance / Sensory Integration and Balance Test Score
Description
Change from baseline sensory integration and balance test score in Biodex Balance System SD at 8 weeks
Time Frame
Eight weeks
Secondary Outcome Measure Information:
Title
Peripheral Muscle Strength
Description
Change from baseline M. Quadriceps strength at 8 weeks. It will be performed using an electronic hand dynamometer (Commander Muscle Tester; JTECH Medical, USA). M. Quadriceps muscle strength will be measured; it will evaluate the isometric muscle strength of that muscle by applying maximum resistance to the M. Quadriceps muscle with the electronic hand dynamometer.
Time Frame
Eight weeks
Title
Pain Level
Description
Change from baseline Visual Analogue Scale (VAS) at 8 weeks.This scale consists of a horizontal, straight line. The line has a value of 0 at the beginning and a value of 10 at the end. A value of 0 means no pain, a value of 10 means unbearable pain. high values represent severe pain.
Time Frame
Eight weeks
Title
Dyspnea
Description
Change from baseline Modified Medical Research Council Dyspnea Scale (mMRC) at 8 weeks. The Modified Medical Research Council Dyspnea Scale (mMRC) is a five-item scale based on various activities that cause breathlessness. The scale is rated from "0" to "4". High values indicate severe shortness of breath.
Time Frame
Eight weeks
Title
Health-Related Quality of Life
Description
Change from baseline St. George's Respiratory Questionnaire (SGRQ) at 8 weeks. St. George's Respiratory Questionnaire consists of 76 questions that can be filled in about 15 minutes. It consists of 3 subgroups that evaluate respiratory symptoms (dyspnea, cough, sputum, wheezing, severity and frequency), activity status (physical functions that cause shortness of breath, housework, hobbies) and the impact of the disease (social activities and psychological state). The three parts of the test are scored separately and the total score is calculated. Scores range from 0-100. A score of zero indicates normal and a score of 100 indicates maximum disability.
Time Frame
Eight weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Being diagnosed with interstitial lung disease (idiopathic pulmonary fibrosis, collagen vascular diseases, sarcoidosis, etc.), Being clinically stable, Not receiving supplemental oxygen therapy, No pulmonary infection in the last 6 weeks, Being ambulation. Exclusion Criteria: Presence of obstructive pulmonary disease such as chronic obstructive pulmonary disease (COPD), asthma, bronchiectasis Presence of a history of effort-induced syncope Presence of severe orthopedic or neurological disease Presence of unstable serious cardiac disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Onur AYDIN, PhD (c)
Organizational Affiliation
Bezmialem Vakif University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bezmialem Vakif University
City
Istanbul
State/Province
Fatih/Istanbul
ZIP/Postal Code
34093
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Respiratory Muscle Training in Interstitial Lung Patients

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