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

Primary Purpose

Idiopathic Pulmonary Fibrosis, IPF

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Inspiratory Muscle Training (IMT)
Sham IMT
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis focused on measuring idiopathic pulmonary fibrosis, inspiratory muscle training, home-based, rehabilitation

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dokuz Eylul University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Study Group

Sham Group

Arm Description

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

Patients who perform Sham IMT

Outcomes

Primary Outcome Measures

Change in inspiratory muscle strength
MIP/MEP
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.
Change in Functional capacity
Maximal distance in 6 minute walk test

Secondary Outcome Measures

Change in percentages of forced expiratory volume in one second
Lung function tests: Percentages of forced expiratory volume in one second (FEV1).
Change in percentages of forced vital capacity
Lung function tests: Percentages of forced vital capacity (FVC).
Change in diffusing capacity of the lung for carbon monoxide
Lung function tests: Diffusing capacity of the lung for carbon monoxide (DLCO).

Full Information

First Posted
April 25, 2022
Last Updated
May 11, 2023
Sponsor
Dokuz Eylul University
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1. Study Identification

Unique Protocol Identification Number
NCT05353556
Brief Title
Effects of Home-based Inspiratory Muscle Training in Patients With IPF
Official Title
Effects of Home-based Inspiratory Muscle Training in Patients With Idiopathic Pulmonary Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 21, 2022 (Actual)
Primary Completion Date
April 25, 2022 (Actual)
Study Completion Date
May 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis, IPF
Keywords
idiopathic pulmonary fibrosis, inspiratory muscle training, home-based, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Experimental
Arm Description
Patients who perform inspiratory muscle training (IMT) with %50 loading
Arm Title
Sham Group
Arm Type
Sham Comparator
Arm Description
Patients who perform Sham IMT
Intervention Type
Device
Intervention Name(s)
Inspiratory Muscle Training (IMT)
Intervention Description
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
Intervention Name(s)
Sham IMT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in inspiratory muscle strength
Description
MIP/MEP
Time Frame
8 weeks
Title
Change in Dyspnea
Description
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.
Time Frame
8 weeks
Title
Change in Functional capacity
Description
Maximal distance in 6 minute walk test
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change in percentages of forced expiratory volume in one second
Description
Lung function tests: Percentages of forced expiratory volume in one second (FEV1).
Time Frame
8 weeks
Title
Change in percentages of forced vital capacity
Description
Lung function tests: Percentages of forced vital capacity (FVC).
Time Frame
8 weeks
Title
Change in diffusing capacity of the lung for carbon monoxide
Description
Lung function tests: Diffusing capacity of the lung for carbon monoxide (DLCO).
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rıdvan Aktan, PhD
Organizational Affiliation
Izmir University of Economics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dokuz Eylul University
City
Izmir
State/Province
Balcova
ZIP/Postal Code
35330
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
14969575
Citation
Selman M, Thannickal VJ, Pardo A, Zisman DA, Martinez FJ, Lynch JP 3rd. Idiopathic pulmonary fibrosis: pathogenesis and therapeutic approaches. Drugs. 2004;64(4):405-30. doi: 10.2165/00003495-200464040-00005.
Results Reference
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PubMed Identifier
18843927
Citation
Jastrzebski D, Kozielski J, Zebrowska A. [Pulmonary rehabilitation in patients with idiopathic pulmonary fibrosis with inspiratory muscle training]. Pneumonol Alergol Pol. 2008;76(3):131-41. Polish.
Results Reference
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PubMed Identifier
19561392
Citation
Kagaya H, Takahashi H, Sugawara K, Kasai C, Kiyokawa N, Shioya T. Effective home-based pulmonary rehabilitation in patients with restrictive lung diseases. Tohoku J Exp Med. 2009 Jul;218(3):215-9. doi: 10.1620/tjem.218.215.
Results Reference
background
PubMed Identifier
15833676
Citation
Tzanakis N, Samiou M, Lambiri I, Antoniou K, Siafakas N, Bouros D. Evaluation of health-related quality-of-life and dyspnea scales in patients with idiopathic pulmonary fibrosis. Correlation with pulmonary function tests. Eur J Intern Med. 2005 Apr;16(2):105-112. doi: 10.1016/j.ejim.2004.09.013.
Results Reference
background
PubMed Identifier
18811886
Citation
Peng S, Li Z, Kang J, Hou X. Cross-sectional and longitudinal construct validity of the Saint George's Respiratory Questionnaire in patients with IPF. Respirology. 2008 Nov;13(6):871-9. doi: 10.1111/j.1440-1843.2008.01359.x.
Results Reference
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Effects of Home-based Inspiratory Muscle Training in Patients With IPF

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