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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05353556
Enrollment
28
Registered
2022-04-29
Start date
2022-02-21
Completion date
2022-05-30
Last updated
2024-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Pulmonary Fibrosis, IPF

Keywords

idiopathic pulmonary fibrosis, inspiratory muscle training, home-based, rehabilitation

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.

Interventions

DEVICEInspiratory 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.

DEVICESham 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.

Sponsors

Dokuz Eylul University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in inspiratory muscle strength8 weeksMIP

Secondary

MeasureTime frameDescription
Change in percentages of forced expiratory volume in one second8 weeksLung function tests: Percentages of forced expiratory volume in one second (FEV1).
Change in percentages of forced vital capacity8 weeksLung function tests: Percentages of forced vital capacity (FVC).
Change in diffusing capacity of the lung for carbon monoxide8 weeksLung function tests: Diffusing capacity of the lung for carbon monoxide (DLCO).
Change in Dyspnea8 weeksThe 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 Functional capacity8 weeksMaximal distance in 6 minute walk test

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026