Clinical trial NCT05106556: 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
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 24
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1: Inspiratory Muscle Training (IMT) Group Group 2: Control Group
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Respiratory Function Test / Forced Vital Capacity (FVC)
timeFrame: Eight weeks
measure: Respiratory Function Test / Forced Expiratory Volume 1 second (FEV1)
timeFrame: Eight weeks
measure: Respiratory Function Test / Peak Expiratory Flow (PEF)
timeFrame: Eight weeks
measure: Respiratory Function Test / Tiffeneau-Pinelli index (FEV1/FVC)
timeFrame: Eight weeks
measure: Respiratory Muscle Strength / Maximum Inspiratory Pressure (MIP)
timeFrame: Eight weeks
measure: Respiratory Muscle Strength / Maximum Expiratory Pressure (MEP)
timeFrame: Eight weeks
measure: Functional Capacity
timeFrame: Eight weeks
measure: Balance / Postural Stability
timeFrame: Eight weeks
measure: Balance / Limits of Stability
timeFrame: Eight weeks
measure: Balance / Sensory Integration and Balance Test Score
timeFrame: Eight weeks
Secondary outcomes:
measure: Peripheral Muscle Strength
timeFrame: Eight weeks
measure: Pain Level
timeFrame: Eight weeks
measure: Dyspnea
timeFrame: Eight weeks
measure: Health-Related Quality of Life
timeFrame: Eight weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
state: Fatih/Istanbul
Study officials:
affiliation: Bezmialem Vakif University
name: Onur AYDIN, PhD (c)
role: PRINCIPAL_INVESTIGATOR
References: