Effects of a new respiratory muscle training device in community-dwelling elderly men: an open-label, randomized, non-inferiority trial

BACKGROUND: Respiratory 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. METHODS: This 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, VO(2) 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. RESULTS: Among 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%). CONCLUSION: Compared 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 REGISTRATION: This trial was registered in the database cris.nih.go.kr (registration number KCT0003901) on 10/05/2019.