Novel versus Traditional Inspiratory Muscle Training Regimens as Home-Based, Stand-Alone Therapies in COPD: Protocol for a Randomized Controlled Trial

Magno F Formiga, Filip Dosbaba, Martin Hartman, Ladislav Batalik, Marek Plutinsky, Kristian Brat, Ondrej Ludka, Lawrence P Cahalin, Magno F Formiga, Filip Dosbaba, Martin Hartman, Ladislav Batalik, Marek Plutinsky, Kristian Brat, Ondrej Ludka, Lawrence P Cahalin

Abstract

Background: Subjects with COPD frequently develop considerable weakness and deconditioning of the inspiratory musculature, which can be corrected with inspiratory muscle training (IMT). While rehabilitation centers may be able to provide IMT as part of the rather complex management of COPD, there is currently a lack of rehabilitation services in the Czech Republic. Remote IMT may then benefit subjects with COPD who are unable to attend or do not have access to rehabilitation programs. We aim at evaluating the utility of the test of incremental respiratory endurance (TIRE) as an at-home IMT method in subjects with COPD, while comparing the effectiveness of this novel training approach to the outcomes of traditional, threshold loading IMT protocols.

Methods/design: This prospective, randomized controlled trial will comprise 8 weeks of at-home IMT sessions with remote supervision followed by 4 months of unsupervised, independent IMT. Eligible subjects will be randomly assigned to one of the following three distinct home-based IMT protocols: (1) TIRE, (2) Threshold loading, and (3) Sham training. Subjects allocated to the TIRE group will train once daily using an advanced IMT electronic system (PrO2), while the other two groups will receive threshold devices. 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.

Discussion: While we acknowledge the value of threshold loading IMT protocols, we believe that the TIRE training method has the potential to provide additional clinical benefits in COPD given its sophisticated remote tracking system and ability to modulate all aspects of muscular performance, including not only strength but also endurance, power and work capacity, allowing users to achieve considerably higher inspiratory pressures throughout the full range of inspiration when compared to other more traditionally used IMT methods.

Keywords: chronic obstructive pulmonary disease; inspiratory muscle training; pulmonary rehabilitation; quality of life; telemedicine; test of incremental respiratory endurance.

Conflict of interest statement

Marek Plutinsky reports personal fees from Boehringer Ingelheim, Berlin Chemie, and CSL Behring, outside the submitted work. The authors report no other potential conflicts of interest in this work.

© 2020 Formiga et al.

Figures

Figure 1
Figure 1
Comparison of the maximal inspiratory effort slopes obtained via the TIRE method and traditional inspiratory muscle assessment utilizing a threshold device.
Figure 2
Figure 2
Outline of study design. Subjects are assigned to one of three home-based inspiratory muscle training groups and expected to train for 8 weeks.
Figure 3
Figure 3
Graphic presentation of a sustained maximal inspiratory effort performed using the PrO2 device and software. In this example, the user achieved a MIP of 90 cmH2O, a SMIP of 606 PTU reflecting the area under the pressure-time curve. The entire maneuver lasted 15 seconds.

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