Effect of Respiratory Muscle Training in Interstitial Lung Patients

Not Applicable

• Conditions: Interstitial Lung Disease

• Registration Number: NCT05106556
• Lead Sponsor: Bezmialem Vakif University

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.

Study Timeline

• Study Start: 2019-12-09
• Status Verified: 2021-10
• Study First Submitted: 2021-10-13
• Study First Submitted QC: 2021-10-30
• Last Update Submitted: 2021-10-30
• Study First Posted: 2021-11-03
• Last Update Posted: 2021-11-03
• Primary Completion: 2022-01-03
• Study Completion: 2022-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Respiratory Function Test / Forced Vital Capacity (FVC)	Eight weeks	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 Muscle Strength / Maximum Expiratory Pressure (MEP)	Eight weeks	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.
Balance / Limits of Stability	Eight weeks	Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks
Balance / Sensory Integration and Balance Test Score	Eight weeks	Change from baseline sensory integration and balance test score in Biodex Balance System SD at 8 weeks
Respiratory Function Test / Peak Expiratory Flow (PEF)	Eight weeks	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)	Eight weeks	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)	Eight weeks	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 Function Test / Forced Expiratory Volume 1 second (FEV1)	Eight weeks	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.
Functional Capacity	Eight weeks	Change from baseline distance covered in six-minute walk test at 8 weeks
Balance / Postural Stability	Eight weeks	Change from baseline postural stability test score in Biodex Balance System at 8 weeks

Secondary Outcome Measures

Name	Time	Method
Dyspnea	Eight weeks	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	Eight weeks	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.
Peripheral Muscle Strength	Eight weeks	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	Eight weeks	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.

Trial Locations

Locations (1)

Bezmialem Vakif University; 🇹🇷 Istanbul, Fatih/Istanbul, Turkey