Effectiveness of preoperative pulmonary rehabilitation in patients with lung cancer combined with moderate to severe COPD: study protocol for a randomized controlled trial

Background: Lung cancer surgery is associated with a high incidence of postoperative pulmonary complications (PPCs), especially in high-risk patients, such as moderate to severe COPD, long-term smoking, and low cardiorespiratory endurance. Preliminary evidence suggests that pulmonary rehabilitation can reduces the incidence of PPCs, However, there is still no consensus on the specific methods of pulmonary rehabilitation. The aim of the present study is to evaluate the effectiveness of preoperative pulmonary rehabilitation in patients with lung cancer combined with moderate to severe COPD through the improved pulmonary rehabilitation program,and to explore the influence of preoperative pulmonary rehabilitation on the surgical outcome of high-risk patients . Methods: A randomized, prospective, single-blind (evaluator) clinical trial. Participants（n=70）will be randomly divided into two groups. The intervention group will receive 2 weeks preoperative pulmonary rehabilitation (inspiratory muscle training + aerobic exercise + preoperative rehabilitation education), the control group will only receive preoperative rehabilitation education. Both groups will routinely receive the guidance training (contains breathing exercises and early ambulation) after surgery. The primary outcome is incidence of PPCs defined with the Melbourne Group Scale diagnostic scoring tool. Secondary outcomes include pre- and post-operative hospital length of stay (LOS), pulmonary function, inspiratory muscle strength, exercise capacity ,cardiopulmonary endurance, grip strength, health-related quality of life (HRQoL), fatigue, the sleep quality ,anxiety and depression. Discussion: This trial was designed to test the hypothesis that preoperative pulmonary rehabilitation can improve preoperative cardiopulmonary function of patients with lung cancer complicated with moderate and severe COPD, reduce the incidence of PPCs, shorten the length of hospitalization, Improve fatigue, quality of life and more. Trial registration: ChiCTR,ChiCTR2400093829.Registered 12 December 2024,https://www.chictr.o rg.cn/