Clinical trial NCT05353556: 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
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Pulmonary Fibrosis
IPF
Keywords: idiopathic pulmonary fibrosis
inspiratory muscle training
home-based
rehabilitation
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2022-04-29
Enrollment: 28
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in inspiratory muscle strength
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in percentages of forced expiratory volume in one second
timeFrame: 8 weeks
measure: Change in percentages of forced vital capacity
timeFrame: 8 weeks
measure: Change in diffusing capacity of the lung for carbon monoxide
timeFrame: 8 weeks
measure: Change in Dyspnea
timeFrame: 8 weeks
measure: Change in Functional capacity
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Dokuz Eylul University
state: Balcova
Study officials:
affiliation: Izmir University of Economics
name: Rıdvan Aktan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.