Abstract
BackgroundRespiratory muscle training (RMT) has various clinical benefits in older adults; however, the low adherence to training remains a challenging issue. The present study aimed to confirm the efficacy of a new device that combines inspiratory muscle training and a positive expiratory pressure (IMT/PEP) compared to that of a Threshold IMT device (Philips Respironics Inc), and to determine whether home-based training differed from rehabilitation center training.MethodsThis four-arm, multicenter, parallel, non-inferiority trial randomized 80 active community-dwelling older men (mean age = 72.93 ± 5.02 years) to center-based groups (new IMT/PEP device or Threshold IMT device; 16 supervised sessions) or home-based groups (new IMT/PEP device or Threshold IMT device; 2 supervised sessions and individual sessions). Participants in all groups performed RMT twice a day for 8 weeks. Assessments were performed at baseline and post-training. The primary outcomes were maximum inspiratory pressure and maximal expiratory pressure. The secondary outcomes included forced vital capacity and forced expiratory volume in the first second, peak cough flow, diaphragm thickness, VO2 peak, the International Physical Activity Questionnaire score, electromyographic activities of the sternocleidomastoid muscle, and skeletal muscle mass and phase angle as measured by bioimpedance analysis. In addition, rates of adherence to each protocol were also compared.ResultsAmong all groups, the maximal inspiratory pressure was improved post-training, while the maximal expiratory pressure showed improvement only in the IMT/PEP groups. The overall non-inferiority of the IMT/PEP device was thus validated. A statistically significant improvement in diaphragm thickness was found. However, no consistent improvement was shown in other secondary outcomes. No significant difference in training adherence rate between protocols was observed (mean adherence rate of 91–99%).ConclusionCompared to the Threshold IMT, the new IMT/PEP device did not result in a significant difference in maximal inspiratory pressure but did improve maximal expiratory pressure in older men. The IMT/PEP device’s improved usability, which is associated with exercise adherence, provided distinct advantages in this cohort. If proper education is first provided, home-based RMT alone may provide sufficient effects in older individuals.Trial registrationThis trial was registered in the database cris.nih.go.kr (registration number KCT0003901) on 10/05/2019.
Highlights
Respiratory muscle training (RMT) has various clinical benefits in older adults; the low adher‐ ence to training remains a challenging issue
The effect and adherence to center-based RMT and home-based RMT have not yet been compared. The aim of this present study was to confirm the efficacy of the new inspiratory muscle training (IMT)/positive-expiratory pressure (PEP) device and to determine whether home-based training was better than rehabilitation center-based training in terms of improving the training adherence rate and effect. In this randomized clinical trial, we investigate whether RMT using the new combined IMT/PEP device was non-inferior to that using the existing Threshold IMT (Philips Respironics Inc., Murrysville, PA, USA) device, and whether a home-based RMT program had non-inferior effects compared to center-based RMT
Continuous variables are reported as mean ± standard deviation (95% confidence interval) *Paired t-test. ** Wilcoxon signed-rank test. †Independent t-test. †† Mann–Whitney test Abbreviations: maximum inspiratory pressure (MIP) maximal expiratory pressure, MEP maximal expiratory pressure, ES Effect size
Summary
Respiratory muscle training (RMT) has various clinical benefits in older adults; the low adher‐ ence to training remains a challenging issue. Respiratory muscle strength decreases in older individuals with sarcopenia [4] These physiological changes in older individuals make it difficult to maintain physical activity, which is essential for maintaining a healthy lifestyle [5]. Low adherence to pulmonary rehabilitation exercise, including RMT, remains problematic [12]. For these reasons, we have designed a new device that combines inspiratory muscle training (IMT) and positive-expiratory pressure (PEP) for enhancing exercise adherence and usability. As the era of the COVID-19 pandemic continues, poor access to training centers and decreased completion of exercises are challenges in older individuals as well as in patients with respiratory diseases [13, 14]. The effect and adherence to center-based RMT and home-based RMT have not yet been compared
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