Effects of Home-based Inspiratory Muscle Training in Patients With IPF

Study Overview
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Brief Summary
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The aim of this study is to investigate the effects of the home-based inspiratory muscle training program on lung functions, dyspnea, inspiratory muscle strength, functional capacity and quality of life in patients with idiopathic pulmonary fibrosis. Patients are evaluated before the inspiratory muscle training and after 8 weeks of training.

Detailed Description
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The IMT protocol consisted of home-based high-intensity daily training - two cycles of 30 breaths with a 1-min rest between sets, twice a day for 8 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The intensity of the training was set to 50% of each patient's maximal inspiratory pressure measured every week and was adjusted weekly based on the modified Borg scale from 4 to 6 regarding respiratory effort performed during the session. Patients are evaluated before the inspiratory muscle training and after 8 weeks of training.

Official Title
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Effects of Home-based Inspiratory Muscle Training in Patients With Idiopathic Pulmonary Fibrosis

Conditions
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Idiopathic Pulmonary Fibrosis, IPF

Intervention / Treatment
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* Device: Inspiratory Muscle Training (IMT)
* Device: Sham IMT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosing Idiopathic Pulmonary Fibrosis by a pulmonologist; Aged between 40 and 75 years; Volunteering to research; Stable clinical condition (same medication routine and/or no acute exacerbation in the last for the last 4 weeks). Exclusion Criteria: Inability of the participant to understand or perform the procedures proposed during the evaluations or training program. Participating in any pulmonary rehabilitation programs; A previous pneumonectomy or lobectomy operation; Pneumonia in the last 4 weeks; Any pulmonary infection during the study; Requirement for supplemental oxygen therapy while resting. Having Covid-19 disease (during the study or in the past) Orthopaedic or neurological conditions affecting the ability to independent walking

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study was designed as a prospective and experimental study. Participants were randomly divided into two groups; a study group and a control group. The study group will perform inspiratory muscle training at 50% of maximal inspiratory pressure (MIP), and the control group received sham training for 8 weeks.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br>Patients who perform inspiratory muscle training (IMT) with %50 loading | Device: Inspiratory Muscle Training (IMT)<br>* The IMT protocol will consist of home-based high-intensity daily training - two cycles of 30 breaths with a 1-min rest between sets, twice a day for 8 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The intensity of the training will be set to 50% of each patient's maximal inspiratory pressure measured every week and was adjusted weekly based on the modified Borg scale from 4 to 6 regarding respiratory effort performed during the session.<br>|
| Sham Comparator: Sham Group<br>Patients who perform Sham IMT | Device: Sham IMT<br>* The IMT protocol will consist of home-based daily training - two cycles of 30 breaths with a 1-min rest between sets, twice a day for 8 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The intensity of the training will be set to the lowest intensity of the IMT Threshold device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in inspiratory muscle strength | MIP/MEP | 8 weeks | 
| Change in Dyspnea | The modified Medical Research Council (mMRC) Dyspnea Scale was used to evaluate the severity of dyspnea. Commonly used in the assessment of dyspnea in COPD, mMRC has a five-level scoring system ranging from 0 to 4. A high score indicates an increased sense of dyspnea. | 8 weeks | 
| Change in Functional capacity | Maximal distance in 6 minute walk test | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in percentages of forced expiratory volume in one second | Lung function tests: Percentages of forced expiratory volume in one second (FEV1). | 8 weeks | 
| Change in percentages of forced vital capacity | Lung function tests: Percentages of forced vital capacity (FVC). | 8 weeks | 
| Change in diffusing capacity of the lung for carbon monoxide | Lung function tests: Diffusing capacity of the lung for carbon monoxide (DLCO). | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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idiopathic pulmonary fibrosis, inspiratory muscle training, home-based, rehabilitation