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Completed

NCT Number: NCT05353556

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

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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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dokuz Eylul University

Izmir, Balcova, 35330, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inspiratory Muscle Training (IMT)

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 IMT

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.

Primary outcomes

  1. Change in inspiratory muscle strength

    Time frame: 8 weeks

    MIP

Secondary outcomes

  1. 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).

  2. Change in percentages of forced vital capacity

    Time frame: 8 weeks

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

  3. 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).

  4. 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.

  5. Change in Functional capacity

    Time frame: 8 weeks

    Maximal distance in 6 minute walk test

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 29, 2022
Registry last updated
Jan 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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