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| Name | Class |
|---|---|
| University Hospital, Geneva | OTHER |
| Centre Hospitalier Universitaire Vaudois | OTHER |
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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.
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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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 | No Intervention | Control group: standard oncologic care without a structured exercise intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative Exercise Training | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in peak oxygen uptake (VO₂peak) from baseline to pre-surgery | The primary endpoint is peak oxygen uptake (VO₂peak), measured by standardized cardiopulmonary exercise testing (CPET). VO₂peak reflects the integrative capacity of the cardiovascular, pulmonary, and muscular systems during maximal exertion and is a validated indicator of surgical fitness and perioperative risk. VO₂peak will be assessed at baseline (before induction therapy) and repeated 24-72 hours prior to surgery. The primary analysis will compare pre-surgery VO₂peak between groups using ANCOVA adjusted for baseline VO₂peak. | From baseline to 24-72 hours prior to surgery at approximately 12-16 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ventilatory efficiency (VE/VCO₂ slope) from baseline to pre-surgery | VE/VCO₂ slope measured during CPET as an index of ventilatory efficiency and ventilation-perfusion matching. Elevated values are associated with increased perioperative risk. The outcome is the between-group difference at pre-surgery adjusted for baseline value. | From baseline to 24-72 hours prior to surgery at approximately 12-16 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpitaux Universitaires de Genève | Geneva | Canton of Geneva | 1205 | Switzerland |
Individual participant data (IPD) underlying the results reported in the publication of the primary and secondary outcomes will be shared. This will include de-identified individual-level data for baseline characteristics, group allocation, primary outcome data (VO₂peak at baseline and pre-surgery), secondary outcome measures (VE/VCO₂ slope, 6-minute walk distance, postoperative complications, length of stay, pulmonary function, skeletal muscle mass, and quality of life scores), and adherence data.
All shared data will be fully de-identified in accordance with applicable data protection regulations. The study protocol, statistical analysis plan, and data dictionary will also be made available.
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|
| Change in 6-minute walk distance from baseline to pre-surgery | Distance walked during the standardized 6-minute walk test (6MWT) performed indoors on a 30-meter corridor according to established guidelines. The outcome is the between-group difference in walking distance at pre-surgery adjusted for baseline. | From baseline to 24-72 hours prior to surgery at approximately 12-16 weeks. |
| Rate of 30-day postoperative cardiopulmonary complications | Proportion of patients experiencing at least one predefined cardiopulmonary complication within 30 days after surgery, including atrial fibrillation, pneumonia, prolonged air leak, pulmonary embolism, ARDS, pneumothorax, or myocardial infarction. Between-group comparison. | From surgery to 30 days postoperatively. |
| Length of postoperative hospital stay | Number of days from the date of surgery to hospital discharge. Comparison of mean length of stay between intervention and control groups. | From surgery until hospital discharge. |
| Change in health-related quality of life (EORTC QLQ-C30 global score) | Health-related quality of life assessed using the EORTC QLQ-C30 questionnaire (version 3.0). The primary QoL endpoint is the global health status/quality of life score. Between-group comparison of change from baseline to pre-surgery. | From baseline to 24-72 hours prior to surgery at approximately 12-16 weeks. |
| Change in skeletal muscle cross-sectional area on CT imaging | Skeletal muscle cross-sectional area and radiodensity measured on CT scans at the L3 vertebral level. Change from baseline to pre-surgery compared between groups as an index of sarcopenia and muscle quality. | From baseline to 4-6 weeks prior to surgery at approximately 12 weeks. |
| Change in pulmonary function (FEV1 and DLCO) from baseline to pre-surgery | Forced expiratory volume in 1 second (FEV1) and diffusing capacity for carbon monoxide (DLCO) measured using standardized pulmonary function testing. Between-group comparison of change from baseline to pre-surgery. | From baseline to 24-72 hours prior to surgery at approximately 12-16 weeks. |
| Centre Hospitalier Universitaire Vaudois | Lausanne | Canton of Vaud | 1005 | Switzerland |
|
| Hôpital de Sion | Sion | Valais | 1951 | Switzerland |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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