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

January 8, 2024 updated by: Ridvan Aktan, Dokuz Eylul University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Balcova
      • Izmir, Balcova, Turkey, 35330
        • Dokuz Eylül University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Group
Patients who perform inspiratory muscle training (IMT) with %50 loading
Device: 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.
Sham Comparator: Sham Group
Patients who perform Sham IMT
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in inspiratory muscle strength
Time Frame: 8 weeks
MIP
8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dokuz Eylul University

Investigators

  • Principal Investigator: Rıdvan Aktan, PhD, Izmir University of Economics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2022

Primary Completion (Actual)

April 25, 2022

Study Completion (Actual)

May 30, 2022

Study Registration Dates

First Submitted

April 25, 2022

First Submitted That Met QC Criteria

April 28, 2022

First Posted (Actual)

April 29, 2022

Study Record Updates

Last Update Posted (Actual)

January 10, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RidvanAktan_2022/04-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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