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

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          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.

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          Most cited references 19

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          Pulmonary rehabilitation for chronic obstructive pulmonary disease.

          Widespread application of pulmonary rehabilitation (also known as respiratory rehabilitation) in chronic obstructive pulmonary disease (COPD) should be preceded by demonstrable improvements in function (health-related quality of life, functional and maximal exercise capacity) attributable to the programmes. This review updates the review reported in 2006.
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            Impact of inspiratory muscle training in patients with COPD: what is the evidence?

            A meta-analysis including 32 randomised controlled trials on the effects of inspiratory muscle training (IMT) in chronic obstructive pulmonary disease (COPD) patients was performed. Overall and subgroup analyses with respect to training modality (strength or endurance training, added to general exercise training) and patient characteristics were performed. Significant improvements were found in maximal inspiratory muscle strength (P(I,max); +13 cmH₂O), endurance time (+261 s), 6- or 12-min walking distance (+32 and +85 m respectively) and quality of life (+3.8 units). Dyspnoea was significantly reduced (Borg score -0.9 point; Transitional Dyspnoea Index +2.8 units). Endurance exercise capacity tended to improve, while no effects on maximal exercise capacity were found. Respiratory muscle endurance training revealed no significant effect on P(I,max), functional exercise capacity and dyspnoea. IMT added to a general exercise programme improved P(I,max) significantly, while functional exercise capacity tended to increase in patients with inspiratory muscle weakness (P(I,max) <60 cmH₂O). IMT improves inspiratory muscle strength and endurance, functional exercise capacity, dyspnoea and quality of life. Inspiratory muscle endurance training was shown to be less effective than respiratory muscle strength training. In patients with inspiratory muscle weakness, the addition of IMT to a general exercise training program improved P(I,max) and tended to improve exercise performance.
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              Differences in content and organisational aspects of pulmonary rehabilitation programmes.

              The aim was to study the overall content and organisational aspects of pulmonary rehabilitation programmes from a global perspective in order to get an initial appraisal on the degree of heterogeneity worldwide. A 12-question survey on content and organisational aspects was completed by representatives of pulmonary rehabilitation programmes that had previously participated in the European Respiratory Society (ERS) COPD Audit. Moreover, all ERS members affiliated with the ERS Rehabilitation and Chronic Care and/or Physiotherapists Scientific Groups, all members of the American Association of Cardiovascular and Pulmonary Rehabilitation, and all American Thoracic Society Pulmonary Rehabilitation Assembly members were asked to complete the survey via multiple e-mailings. The survey has been completed by representatives of 430 centres from 40 countries. The findings demonstrate large differences among pulmonary rehabilitation programmes across continents for all aspects that were surveyed, including the setting, the case mix of individuals with a chronic respiratory disease, composition of the pulmonary rehabilitation team, completion rates, methods of referral and types of reimbursement. The current findings stress the importance of future development of processes and performance metrics to monitor pulmonary rehabilitation programmes, to be able to start international benchmarking, and to provide recommendations for international standards based on evidence and best practice.
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                Author and article information

                Journal
                Int J Chron Obstruct Pulmon Dis
                Int J Chron Obstruct Pulmon Dis
                copd
                copd
                International Journal of Chronic Obstructive Pulmonary Disease
                Dove
                1176-9106
                1178-2005
                11 September 2020
                2020
                : 15
                : 2147-2155
                Affiliations
                [1 ]Departamento de Fisioterapia, Universidade Estadual da Paraíba , Campina Grande, PB, Brazil
                [2 ]Department of Rehabilitation, University Hospital Brno , Brno, Czech Republic
                [3 ]Department of Respiratory Diseases, University Hospital Brno , Brno, Czech Republic
                [4 ]Faculty of Medicine, Masaryk University , Brno, Czech Republic
                [5 ]Department of Physical Therapy, University of Miami – Miller School of Medicine , Coral Gables, FL, USA
                Author notes
                Correspondence: Filip Dosbaba; Ladislav Batalik Department of Rehabilitation, University Hospital Brno , Jihlavska 20, Brno62500, Czech Republic Email dosbaba.filip@fnbrno.cz; batalik.ladislav@fnbrno.cz
                Article
                266234
                10.2147/COPD.S266234
                7494397
                © 2020 Formiga et al.

                This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

                Page count
                Figures: 3, Tables: 2, References: 34, Pages: 9
                Funding
                Funded by: the Ministry of Health, Czech Republic – conceptual development of research organization;
                This study is supported by the Ministry of Health, Czech Republic – conceptual development of research organization (FNBr, 65269705).
                Categories
                Study Protocol

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