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

NCT07479407 | Not Yet Recruiting DMC

• 1 other identifier: Preoperative exercise training
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Locally Advanced Non-small Cell Lung Cancer (NSCLC)

Keywords

Non-small cell lung cancer; Locally advanced NSCLC; Neoadjuvant therapy; Immunotherapy; Prehabilitation; Exercise training; VO2peak; Cardiopulmonary exercise testing; Thoracic surgery; Postoperative complications

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (7)

• Change in ventilatory efficiency (VE/VCO₂ slope) from baseline to pre-surgery

  From baseline to 24-72 hours prior to surgery at approximately 12-16 weeks.

• Change in 6-minute walk distance from baseline to pre-surgery

  From baseline to 24-72 hours prior to surgery at approximately 12-16 weeks.

• Rate of 30-day postoperative cardiopulmonary complications

  From surgery to 30 days postoperatively.

• Length of postoperative hospital stay

  From surgery until hospital discharge.

• Change in health-related quality of life (EORTC QLQ-C30 global score)

  From baseline to 24-72 hours prior to surgery at approximately 12-16 weeks.

Study Arms (2)

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.

Procedure: Preoperative Exercise Training

Control

NO INTERVENTION

Control group: standard oncologic care without a structured exercise intervention.

Interventions

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• Confirmed diagnosis of stage IIB, IIIA, IIIB or oligo-metastatic stage IV NSCLC.
• Planned induction therapy with either chemotherapy, immunotherapy or a combination of immuno-chemotherapy followed by an anatomical pulmonary resection.
• Absence of musculoskeletal conditions preventing safe physical exercise.
• Absence of any history of uncontrolled or unstable cardiac disease.
• Agreement to participate in the study by signing the study specific informed consent form.

You may not qualify if:

• Pregnancy (confirmed by a test if applicable).
• Induction therapy already initiated.
• Inability to walk independently.
• Lack of decision-making capacity.
• Oxygen-dependency before the initiation of the induction protocol.
• No capacity for discernment.
• Does not speak French.

Sponsors & Collaborators

• Hôpital du Valais: lead
• University Hospital, Geneva: collaborator
• Centre Hospitalier Universitaire Vaudois: collaborator

Study Sites (3)

Hôpitaux Universitaires de Genève

Geneva, Canton of Geneva, 1205, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1005, Switzerland

Location

Hôpital de Sion

Sion, Valais, 1951, Switzerland

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Postoperative Complications

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 18, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

CH (3)