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

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05353556
• Other study ID #: RidvanAktan_2022/04-03
• Status: Completed
• Phase: N/A
• Start date: February 21, 2022
• Est. completion date: May 30, 2022

Study information

• Verified date: January 2024
• Source: Dokuz Eylul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: May 30, 2022
• Est. primary completion date: April 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• IPF
• Pulmonary Fibrosis
• Respiratory Aspiration

Intervention

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 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.

Locations

Country	Name	City	State
Turkey	Dokuz Eylul University	Izmir	Balcova

Sponsors (1)

Lead Sponsor	Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in inspiratory muscle strength	MIP	8 weeks
Secondary	Change in percentages of forced expiratory volume in one second	Lung function tests: Percentages of forced expiratory volume in one second (FEV1).	8 weeks
Secondary	Change in percentages of forced vital capacity	Lung function tests: Percentages of forced vital capacity (FVC).	8 weeks
Secondary	Change in diffusing capacity of the lung for carbon monoxide	Lung function tests: Diffusing capacity of the lung for carbon monoxide (DLCO).	8 weeks
Secondary	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.	8 weeks
Secondary	Change in Functional capacity	Maximal distance in 6 minute walk test	8 weeks