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Clinical Trials/NCT05106556
NCT05106556
Unknown
N/A

The Effect of Respiratory Muscle Training on Respiratory Parameters, Functional Capacity, Balance and Quality of Life in Interstitial Lung Patients

Bezmialem Vakif University1 site in 1 country24 target enrollmentDecember 9, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Interstitial Lung Disease
Sponsor
Bezmialem Vakif University
Enrollment
24
Locations
1
Primary Endpoint
Respiratory Function Test / Forced Vital Capacity (FVC)
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 9, 2019
End Date
January 31, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Onur Aydın

Lecturer, PT, PhD (c)

Bezmialem Vakif University

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

Outcomes

Primary Outcomes

Respiratory Function Test / Forced Vital Capacity (FVC)

Time Frame: 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)

Time Frame: 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

Time Frame: 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

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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

Time Frame: Eight weeks

Change from baseline distance covered in six-minute walk test at 8 weeks

Balance / Postural Stability

Time Frame: Eight weeks

Change from baseline postural stability test score in Biodex Balance System at 8 weeks

Secondary Outcomes

  • Dyspnea(Eight weeks)
  • Health-Related Quality of Life(Eight weeks)
  • Peripheral Muscle Strength(Eight weeks)
  • Pain Level(Eight weeks)

Study Sites (1)

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