Effect of Respiratory Muscle Training in Interstitial Lung Patients

NCT ID: NCT05106556

Last Updated: 2021-11-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-09
• Study Completion Date: 2022-01-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control Group

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.

Group Type: ACTIVE_COMPARATOR

Conventional Chest Physiotherapy

Intervention Type: OTHER

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.

Inspiratory Muscle Training (IMT) Group

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.

Group Type: EXPERIMENTAL

Conventional Chest Physiotherapy

Intervention Type: OTHER

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.

Inspiratory Muscle Training

Intervention Type: OTHER

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.

Interventions

Conventional Chest Physiotherapy

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

Inspiratory Muscle Training

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bezmialem Vakif University

OTHER

Sponsor Role: lead

Responsible Party

Onur Aydın

Lecturer, PT, PhD (c)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Onur AYDIN, PhD (c)

Role: PRINCIPAL_INVESTIGATOR

Bezmialem Vakif University

Locations

Bezmialem Vakif University

Istanbul, Fatih/Istanbul, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

BezmialemVU-AYDIN-001

Identifier Type: -

Identifier Source: org_study_id