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

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.

Adherence to and impact of home-based high-intensity IMT in people with spinal cord injury: a pilot study

“…IMT training sessions throughout the trial were performed in the home environment and consisted of 42 breaths, completed in 7 sets of 6 breaths, at 80% of the subjects’ maximal baseline effort for the day. Rest time decreased after each set, starting at 40 s and ending with 5 s. The protocol, modeled after one used by Formiga et al [ 46 ], had a similar number of target breaths per week as a successful SCI clinical trial [ 15 ].…”

Inspiratory Muscle Training in Patients with Chronic Obstructive Pulmonary Disease (COPD) as Part of a Respiratory Rehabilitation Program Implementation of Mechanical Devices: A Systematic Review

“…The protocol of a randomized clinical trial comparing a home training program based on an incremental breathing endurance test (TIRE), using the PrO2 device, versus a traditional inspiratory muscle training program using the Threshold IMTR has recently been carried out. The results of this study are not yet published [50].…”

The use of respiratory muscle training in patients with pulmonary dysfunction, internal diseases or central nervous system disorders: a systematic review with meta-analysis

“…Although the role of RMT in mitigating the respiratory complications of viral infection has not yet been confirmed, the available evidence seems to suggest that this training may help reduce the risk of serious complications during viral infection [ 68 ]. It is also worth noting that RMT can be performed independently by the patient at home [ 69 ]. This opens many possibilities for the implementation of telerehabilitation or using new technologies [ 70 ].…”