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

NCT05353556 | Completed

• 1 other identifier: RidvanAktan_2022/04-03
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Pulmonary Fibrosis; IPF

Keywords

idiopathic pulmonary fibrosis; inspiratory muscle training; home-based; rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in inspiratory muscle strength

  MIP

  8 weeks

Secondary Outcomes (5)

• Change in percentages of forced expiratory volume in one second

  8 weeks

• Change in percentages of forced vital capacity

  8 weeks

• Change in diffusing capacity of the lung for carbon monoxide

  8 weeks

• Change in Dyspnea

  8 weeks

• Change in Functional capacity

  8 weeks

Study Arms (2)

Study Group

EXPERIMENTAL

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

Device: Inspiratory Muscle Training (IMT)

Sham Group

SHAM COMPARATOR

Patients who perform Sham IMT

Device: Sham IMT

Interventions

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.

Study Group

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.

Sham Group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dokuz Eylul University

Izmir, Balcova, 35330, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 14969575 BACKGROUND

• 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.

  PMID: 18843927 BACKGROUND

• 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.

  PMID: 19561392 BACKGROUND

• 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.

  PMID: 15833676 BACKGROUND

• 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.

  PMID: 18811886 BACKGROUND

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Rıdvan Aktan, PhD

  Izmir University of Economics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PhD

Model Details: 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.

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: April 29, 2022
• Study Start: February 21, 2022
• Primary Completion: April 25, 2022
• Study Completion: May 30, 2022
• Last Updated: January 10, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)