NCT07479407

Effect of Pre-operative Exercise Training on Cardiorespiratory Fitness in Patients With Locally Advanced Non-small Cell Lung Cancer Undergoing Induction Chemo-immunotherapy Followed by Surgery - a Randomized Controlled Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: Hôpital du Valais · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The PREHAB study focuses on patients with locally advanced non-small cell lung cancer (NSCLC) undergoing neoadjuvant chemotherapy and/or immunotherapy prior to surgical resection. These systemic treatments frequently impair patients' physiological reserve, reduce physical fitness, and may occasionally lead to cancellation of surgery. Surgery itself carries a substantial risk of cardiorespiratory complications and long-term functional decline. The primary objective of this study is to determine whether a supervised exercise program, initiated concomitantly with systemic therapy and continued until surgery, can improve cardiorespiratory fitness, surgical tolerance, and postoperative outcomes. A total of 74 patients will be randomly assigned to one of two groups: an "intervention" group participating in three weekly sessions of supervised endurance and resistance training for 12 to 16 weeks under the guidance of a physiotherapist, and a "control" group receiving usual care without a structured exercise program. The primary endpoint will be peak oxygen uptake (VO₂peak). Secondary outcomes will include postoperative complication rates, length of hospital stay, pulmonary function, skeletal muscle mass, and quality of life. Intervention-related risks, primarily falls or overexertion, will be mitigated through professional supervision. This multicenter study, with recruitment scheduled to begin in 2026, is expected to provide robust evidence regarding the effectiveness of targeted exercise training in improving preoperative fitness and postoperative recovery in patients with locally advanced NSCLC.

Detailed description

The PREHAB study is a prospective, multicenter, randomized controlled trial designed to evaluate the efficacy of a structured, supervised prehabilitation program in patients with locally advanced non-small cell lung cancer (NSCLC) undergoing neoadjuvant chemotherapy and/or immunotherapy prior to surgical resection. Patients with stage III NSCLC increasingly receive multimodal treatment strategies combining systemic therapy followed by surgery. While neoadjuvant chemotherapy and immunotherapy have improved oncologic outcomes, these treatments frequently induce treatment-related deconditioning, sarcopenia, fatigue, and reduced cardiopulmonary reserve. Consequently, a subset of patients experiences functional decline significant enough to compromise surgical eligibility. Moreover, thoracic surgery itself is associated with substantial postoperative morbidity, particularly cardiorespiratory complications, and long-term impairment in physical performance. The PREHAB trial is based on the hypothesis that early, structured, and supervised exercise training initiated concomitantly with systemic therapy and continued until surgery can mitigate treatment-induced physiological deterioration, preserve or enhance cardiorespiratory fitness, and ultimately improve perioperative and postoperative outcomes. A total of 74 patients will be randomized in a 1:1 ratio to either: * Intervention group: participation in a 12-16 week supervised exercise program consisting of three weekly sessions combining endurance and resistance training, delivered by trained physiotherapists. * Control group: standard oncologic care without a structured exercise intervention. The primary endpoint is change in peak oxygen uptake (VO₂peak), measured by cardiopulmonary exercise testing, as an objective marker of cardiorespiratory fitness and surgical resilience. Secondary endpoints include: * Postoperative complication rates * Length of hospital stay * Pulmonary function parameters * Skeletal muscle mass * Health-related quality of life Safety considerations focus primarily on the risk of falls and overexertion, both minimized through professional supervision and individualized exercise prescription. By targeting the vulnerable neoadjuvant window - when patients are exposed to systemic therapy but have not yet undergone surgery - PREHAB aims to redefine perioperative optimization in locally advanced NSCLC. If positive, this trial could provide high-level evidence supporting the integration of structured exercise prehabilitation into standard multimodal lung cancer care pathways.

Conditions

• Locally Advanced Non-small Cell Lung Cancer (NSCLC)

Interventions

Type	Name	Description
PROCEDURE	Preoperative Exercise Training	The intervention consists of a structured, supervised pre-operative exercise training program initiated concomitantly with induction chemo- and/or immunotherapy and continued until 24-72 hours prior to surgery. The program is delivered in an outpatient setting and supervised by trained physiotherapists following a standardized protocol across study sites. Participants randomized to the intervention group will complete three sessions per week, each lasting 45-60 minutes, for a total duration of 12 to 16 weeks depending on the length of induction therapy. Each session combines aerobic and resistance training components. Aerobic exercise is performed on a cycle ergometer at an initial intensity of approximately 60% of baseline VO₂peak, with progressive increases in duration and intensity aiming for 30-40 minutes at a Borg perceived exertion score of 4-6. Resistance training targets major upper and lower muscle groups using functional exercises.

Timeline

• Start date: 2026-04-01
• Primary completion: 2029-03-01
• Completion: 2029-04-01
• First posted: 2026-03-18
• Last updated: 2026-03-18

Locations

3 sites across 1 country: Switzerland