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CompletedNCT05353556Updated Jan 10, 2024

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

An interventional study of Inspiratory Muscle Training (IMT) and Sham IMT in Idiopathic Pulmonary Fibrosis and IPF, sponsored by Dokuz Eylul University. Completed at 1 site in Turkey. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-01-10.

Sponsored by Dokuz Eylul University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Idiopathic Pulmonary Fibrosis
  • IPF

Keywords

  • idiopathic pulmonary fibrosis
  • inspiratory muscle training
  • home-based
  • rehabilitation
03

In context

Pulmonary Fibrosis

680 studies on the registry are indexed under Pulmonary Fibrosis; 119 are open to participants now.

This study's enrollment of 28 is below the median of 50 across 419 interventional studies indexed under Pulmonary Fibrosis.

Browse Pulmonary Fibrosis studies →

Lead sponsor

Dokuz Eylul University is the lead sponsor of 252 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    Study Group

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

    Device: Inspiratory Muscle Training (IMT)

  • Sham comparator
    Sham Group

    Patients who perform Sham IMT

    Device: Sham IMT

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.

06

What researchers measure

Primary outcomes

  1. Change in inspiratory muscle strength

    MIP

    Time frame: 8 weeks

Secondary outcomes

  1. Change in percentages of forced expiratory volume in one second

    Lung function tests: Percentages of forced expiratory volume in one second (FEV1).

    Time frame: 8 weeks

  2. Change in percentages of forced vital capacity

    Lung function tests: Percentages of forced vital capacity (FVC).

    Time frame: 8 weeks

  3. Change in diffusing capacity of the lung for carbon monoxide

    Lung function tests: Diffusing capacity of the lung for carbon monoxide (DLCO).

    Time frame: 8 weeks

  4. 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.

    Time frame: 8 weeks

  5. Change in Functional capacity

    Maximal distance in 6 minute walk test

    Time frame: 8 weeks

07

Study locations

1 site
  • Dokuz Eylul University
    Izmir, Balcova 35330, Turkey
08

References and documents

Publications

  • 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. PubMed 14969575 ↗
  • 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. PubMed 18843927 ↗
  • 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. PubMed 19561392 ↗
  • 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. PubMed 15833676 ↗
  • 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. PubMed 18811886 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05353556
Lead sponsor
Dokuz Eylul University
Responsible party
Ridvan Aktan (Principal Investigator, PhD, Izmir University of Economics) — Principal investigator
First posted
Apr 29, 2022
Start date
Feb 21, 2022
Primary completion
Apr 25, 2022
Completion
May 30, 2022
Last update
Jan 10, 2024

Study contacts

Rıdvan Aktan, PhD
principal investigator · Izmir University of Economics

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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