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

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.