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

Not Applicable

Completed

• Conditions: Idiopathic Pulmonary Fibrosis; IPF
• Interventions: Device: Inspiratory Muscle Training (IMT); Device: Sham IMT

• Registration Number: NCT05353556
• Lead Sponsor: Dokuz Eylul University

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-02-21
• Primary Completion: 2022-04-25
• Study First Submitted: 2022-04-25
• Study First Submitted QC: 2022-04-28
• Study First Posted: 2022-04-29
• Study Completion: 2022-05-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-08
• Last Update Posted: 2024-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group	Inspiratory Muscle Training (IMT)	Patients who perform inspiratory muscle training (IMT) with %50 loading
Sham Group	Sham IMT	Patients who perform Sham IMT

Primary Outcome Measures

Name	Time	Method
Change in inspiratory muscle strength	8 weeks	MIP

Secondary Outcome Measures

Name	Time	Method
Change in Dyspnea	8 weeks	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.
Change in percentages of forced vital capacity	8 weeks	Lung function tests: Percentages of forced vital capacity (FVC).
Change in diffusing capacity of the lung for carbon monoxide	8 weeks	Lung function tests: Diffusing capacity of the lung for carbon monoxide (DLCO).
Change in Functional capacity	8 weeks	Maximal distance in 6 minute walk test
Change in percentages of forced expiratory volume in one second	8 weeks	Lung function tests: Percentages of forced expiratory volume in one second (FEV1).

Trial Locations

Locations (1)

Dokuz Eylul University; 🇹🇷 Izmir, Balcova, Turkey