Lung cancer is a leading cause of cancer-related mortality worldwide. Surgical resection is the primary curative treatment for early-stage non-small cell lung cancer; however, patients often present with compromised physical fitness, which can adversely affect surgical outcomes and postoperative recovery.
Prehabilitation, the process of enhancing a patient's functional capacity before surgery, has emerged as a promising strategy to improve surgical outcomes. Studies have demonstrated that prehabilitation can lead to reductions in postoperative complications, shorter hospital stays, and improved quality of life.
Prehabilitation programs are typically conducted in specialized clinical settings, which may limit accessibility and adherence. Hybrid models that combine home-based and center-based interventions may offer the opportunity for a more flexible option and may address the limited access to specialized care for many patients.
This study primarily aims to evaluate the relative effectiveness of a hybrid prehabilitation program of 15 sessions (incorporating both home-based and center-based components) compared to a center-based prehabilitation program of 15 sessions in patients undergoing surgery for non-small cell lung cancer on the change in oxygen uptake.
The study also aims to evaluate the relative effectiveness of a hybrid prehabilitation program of 15 sessions (incorporating both home-based and center-based components) compared to a center-based prehabilitation program of 15 sessions in patients undergoing surgery for non-small cell lung cancer on the change in peak power output, ventilatory efficiency, functional capacity, quadriceps muscle maximal isometric strength, respiratory muscle strength, maximal peak expiratory flow and cough expiratory flow, quality of life, psychological status as well as adherence, postoperative complications, clinically relevant postoperative complications, length of hospital stay, and environmental impact.
Study design:
This is a prospective, monocentric, randomized controlled equivalence trial with concealed allocation and a single-blind design (blinded evaluator). Participants will be randomly assigned to one of two groups:
Center-based prehabilitation group (15 sessions in total over 3 weeks): participants will attend 15 sessions in the center, over three weeks, comprising:
1 initiation session (approximately 3 hours) including preoperative patient education, instructions on the use of inspiratory muscle training device, endurance training on a cycle ergometer, strength training, and balance exercises.
13 endurance training sessions (1.5 to 2 hours each) focusing on endurance training (15 to 45 minutes), strength training (30 minutes), balance training, and inspiratory muscle training (10 sets of 10 repetitions at 30% of maximal inspiratory pressure).
1 final session (2 to 2.5 hours) with a review of the program and educational reinforcement.
Hybrid prehabilitation group (15 sessions in total over 3 weeks): participants will complete 3 center-based sessions and 12 home-based sessions over three weeks. The center-based sessions will mirror those in the center-based prehabilitation group (initiation, training session, final session). For the home-based component, participants will receive a cycle ergometer, pulse oximeter, activity tracker, and a tablet application (TELEREHAPP) for guidance throughout the program, remote monitoring, and communication. Home-based sessions include:
Endurance training on the cycle ergometer (15 to 45 minutes per session).
Strength training and balance exercises (30 minutes per session).
Inspiratory muscle training (10 sets of 10 repetitions at 30% of maximal inspiratory pressure).
Physical activity coaching, including a daily step goal.
Regular remote monitoring and support via the tablet application, with weekly check-ins from healthcare professionals.
Sample size calculation for equivalence study:
Assuming a mean change difference in peak oxygen uptake between the two groups of 0 ml/kg/min, a significance level (alpha) of 0.05, a power of 80%, an equivalence margin of 1.75 ml/kg/min, and a standard deviation of 1.8 ml/kg/min for the change in peak oxygen uptake after a condensed rehabilitation program of 5 sessions per week during 3 weeks, we plan to recruit 19 patients per group, totaling 38 patients.
Statistical analysis:
Categorical data will be presented as counts (percentages). Continuous descriptive data will be expressed as means (SD) or medians (IQR), depending on their distribution. The normality of distributions will be assessed using the Kolmogorov-Smirnov test.
Intergroup differences will be reported as mean differences (95% confidence intervals). Non-parametric data will be converted to means (SD) using an appropriate method. Results will be interpreted based on the span of the 95% confidence intervals relative to pre-specified outcomes (see Outcome Measures section).
The relative effect of interventions on categorical data will be examined using relative risk (95% confidence intervals).
Statistical analyses will be conducted on an intention-to-treat basis, using the last available observation for preoperative assessment criteria and considering the absence of complications for postoperative complications (for patients who will not ultimately be operated).
A secondary per-protocol analysis will be performed.
A sensitivity analysis will be conducted by including baseline values as a covariate in the model.
Analyses will be performed using GraphPad 8 and R software.
