Effect of inspiratory and expiratory muscle training on respiratory function and decannulation outcome in patients with tracheostomy after stroke: a randomized controlled trial

Background: This study aimed to evaluate the clinical efficacy and safety of inspiratory and expiratory muscle training (IEMT) for patients who underwent tracheostomy after stroke. Methods: The study was an investigator-initiated, single-center, two-arm, evaluator-blinded, randomized clinical trial conducted at West China Hospital of Sichuan University, China, from January 2022 to June 2022. The patients were randomly divided into the intervention group and control group. Patients in both groups received conventional clinical, rehabilitation treatment and usual care. The intervention group also received IEMT for three weeks. There were three primary outcomes including maximal inspiratory pressure (MIP, cmH(2)O), maximal expiratory pressure (MEP, cmH(2)O) and decannulation outcome after intervention (n, %). The secondary outcomes were other respiratory function outcomes, motor function, activities of daily living (ADL), quality of life (QoL) and the new pulmonary infection rate after the intervention at three weeks. Results: A total of 50 participants were enrolled [25 in each group; 39 (78%) were men; mean (SD) age, 55.94 (11.97) years]. At three weeks, significant differences were found in the MIP [control vs IEMT: 39.04 (6.21) vs 56.28 (10.41), p < 0.001]; MEP [43.48 (5.36) vs 62.16 (10.18), p < 0.001], and tracheal tube extraction success rate [2 (8%) vs 9 (36%), p = 0.019] between the two groups. In addition, the new pulmonary infection rate in the intervention groups were significantly different (all p < 0.05) from those in the control group. Conclusions: IEMT can improve respiratory function, decannulation outcome, among patients with tracheostomy after stroke.