NCT04415788

Inspiratory Muscle Training and COPD

Completed NA Last updated 5 February 2025

What this trial tests

NA trial testing Test of Incremental Respiratory Endurance - IMT in Chronic Obstructive Pulmonary Disease in 48 participants. Completed in 31 December 2024.

Timeline

1 May 2021

Primary endpoint
1 October 2024

31 December 2024

Quick facts

Lead sponsor	Brno University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	48
Start date	1 May 2021
Primary completion	1 October 2024
Estimated completion	31 December 2024
Sites	1 location across Czechia

Drugs / interventions tested

• Test of Incremental Respiratory Endurance - IMT
• Threshold - IMT
• Sham IMT (Low resistence)

Conditions studied

• Chronic Obstructive Pulmonary Disease — all drugs for Chronic Obstructive Pulmonary Disease →

Sponsor

Brno University Hospital

Who can join

40 and older, any sex, with Chronic Obstructive Pulmonary Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Subjects with chronic obstructive pulmonary disease (COPD) frequently develop considerable deterioration in exercise capacity in association with weakness and deconditioning of the respiratory muscles, which can be corrected with specific therapies. While pulmonary rehabilitation is a central component in the rather complex manangement of COPD, there is currently a lack of centers able to provide appropriate rehabilitation services in the Czech Republic. The main objective of this study will be to fully evaluate the utility of the Test of Incremental Respiratory Endurance (TIRE) as an at-home inspiratory muscle training method in subjects with COPD, while comparing the effectiveness of this novel training approach to the outcomes of more traditional ispiratory muscle training protocols.

This prospective, randomized controlled trial will include 2 treatment groups and 1 sham intervention group in a 1:1:1 ratio. All participants will undergo a certain type of IMT regardless of group assignment, which will be perfomed via two different devices. The trial will comprise of an 8-week at-home training period with remote supervision followed by 4 months of unsupervised, independent inspiratory muscle training. Study outcomes will include measures of inspiratory muscle strength and endurance, pulmonary function, COPD-specific symptomatology, functional exercise capacity, surrogate markers of mortality risk, mental health status and health-related quality of life of participants. While investigators acknowledge the value of standard inspiratory muscle training protocols which use Threshold devices, investigators believe that the TIRE training has the potential to provide additional clinical benefits since it is able to modulate all aspects of muscular performance, including strength, endurance and work capacity. Investigators hypothesize that, as a home-based stand-alone rehabilitative therapy, TIRE will be superior to standard IMT in improving COPD-related measures.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Inspiratory muscle training, with or without concomitant pulmonary rehabilitation, for chronic obstructive pulmonary disease (COPD).
   Ammous O, Feki W, Lotfi T, Khamis AM, et al · · 2023 · cited 72× · PMID 36606682 · DOI 10.1002/14651858.cd013778.pub2
2. Novel versus Traditional Inspiratory Muscle Training Regimens as Home-Based, Stand-Alone Therapies in COPD: Protocol for a Randomized Controlled Trial.
   Formiga MF, Dosbaba F, Hartman M, Batalik L, et al · · 2020 · cited 11× · PMID 32982207 · DOI 10.2147/copd.s266234
3. Long-Term Efficacy of Novel and Traditional Home-Based, Remote Inspiratory Muscle Training in COPD: A Randomized Controlled Trial.
   Dosbaba F, Hartman M, Formiga MF, Vlazna D, et al · · 2025 · PMID 40943858 · DOI 10.3390/jcm14176099