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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-21

Study Completion Date

2022-05-30

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.

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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.

Conditions

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Idiopathic Pulmonary Fibrosis IPF

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Study Group

Patients who perform inspiratory muscle training (IMT) with %50 loading

Group Type EXPERIMENTAL

Inspiratory Muscle Training (IMT)

Intervention Type DEVICE

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.

Sham Group

Patients who perform Sham IMT

Group Type SHAM_COMPARATOR

Sham IMT

Intervention Type DEVICE

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.

Interventions

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Inspiratory Muscle Training (IMT)

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.

Intervention Type DEVICE

Sham IMT

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.

Intervention Type DEVICE

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No