Effect of preoperative inspiratory muscle training combined with education course on postoperative pulmonary complications in high-risk patients with lung cancer after video-assisted thoracoscopic surgery: a randomized controlled trial.

Aims: Surgery provides the best chance of survival for early-stage non-small cell lung cancer patients, resulting in a large number of patients requiring surgical resection each year. Preoperative inspiratory muscle training (IMT) is recognized as an important component of the preoperative management of lung cancer, although there is limited evidence for the delivery of a home-based IMT combined with preoperative education. We developed a programme combining short-term home-based IMT and preoperative physiotherapy education ("the programme") for lung patients with lung cancer. This study aims to evaluate the effectiveness of the programme in reducing postoperative pulmonary complications (PPCs) after video-assisted thoracoscopic surgery (VATs) compared to standard care. Methods: This randomized controlled clinical trial (RCT) called for 114 participants at a tertiary hospital to be randomized 1:1 to the control group (CG) and the intervention group (IG). All subjects in both groups received routine perioperative rehabilitation intervention and health education manual. Participants in the IG received a detailed education course plus at least seven-day inspiratory muscle training programme before VATs. Outcome assessments were obtained in person at baseline (T0), the day before surgery (T1) and hospital discharge (T2). Primary outcome measure was PPCs using the Melbourne Group Score (MGS) obtained at discharge. Secondary outcomes were health-related quality of life, maximal inspiratory pressure (MIP), Forced expiratory volume in the first second (FEV1), 6-min walk distance (6MWD), length of hospital stay (LOS), anxiety and depression levels, and hospital costs. SPSS 26.0 statistical analysis software was used for analysis, and bilateral tests were used according to statistical tests. When P < 0.05, the difference was considered statistically significant. Results: In accordance with the protocol, we performed interim unblinding after 50 % of the patients had been enrolled. At the interim analysis, the conditional power was calculated as 0.035 (futility index: 0.965; Supplementary 1), indicating this study should be stopped because there is little chance of achieving statistical significance. No safety concerns were identified. A total of 56 cases (27 cases in the IG and 29 cases in the CG) were finally included from March 2023 to March 2024. The incidence of PPCs between the two groups was not statistically significant (CG = 2/29, IG = 3/27, adjust RR was1.90 (0.29-12.82). One-week preoperative training programme increased MIP, but the results were not sufficient to make a significant difference (P = 0.208). Other secondary outcome measures were also assessed, but no significant between-group differences were found. Conclusion: Preoperative education combined with one-week IMT has no significant clinical significance in reducing the incidence of postoperative pulmonary complications in lung cancer patients after VATs. Longer preoperative inspiratory muscle interventions or in combination with other exercise modalities need to be explored. A follow-up randomized controlled trial can be carried out after appropriate adjustments to the existing intervention and evaluation protocols. Trial registration: This trial was registered on the Chinese Clinical Trial Registry website in January 9, 2023 with code ChiCTR2300067464. URL of registry: https://www.chictr.org.cn/.