Hybrid Prehabilitation Before Thoracic Surgery

Summary

Background and study aims:

Lung cancer is a leading cause of cancer-related deaths worldwide. Patients with non-small cell lung cancer often undergo lung surgery to remove the tumor. Before surgery, patients may participate in prehabilitation programs to improve their physical fitness and overall health, which can lead to better surgical outcomes. Traditionally, these programs are conducted entirely in specialized centers, but places are scarce, limiting access. This study aims to compare the relative effectiveness of a hybrid prehabilitation program, combining home-based and center-based sessions, with the standard center-based program. The primary goal is to assess changes in aerobic capacity, measured by peak oxygen uptake, before and after participation in the prehabilitation program.

Who can participate?

Adults over 18 years old who are scheduled for lung resection surgery to treat diagnosed or suspected non-small cell lung cancer can participate. Participants should be referred for respiratory prehabilitation in a preoperative context and live at home with another adult, present during exercise sessions. The surgery date should be either not yet established at the time of inclusion or scheduled for at least four weeks later. Participants should have a peak oxygen uptake of less than 20 ml/kg/min, be beneficiaries of a social security system, and have read and understood the information letter and signed the consent form.

What does the study involve?

This is a single-center, randomized controlled trial with two groups:

Center-based prehabilitation group: Participants will attend 15 sessions over three weeks (five sessions per week) at the center. The program includes an initial session of therapeutic education and exercise training, followed by 13 prehabilitation sessions, and a final session with educational reinforcement.

Hybrid prehabilitation group: Participants will have three sessions at the center and 13 sessions at home over the same period. They will be provided with equipment such as a cycle ergometer, pulse oximeter, physical activity sensor, and a tablet application (TELEREHAPP) to guide and monitor their home-based exercises. Regular phone contact with healthcare professionals will be maintained for support.

All participants will undergo assessments before and after the program, including an incremental exercise test on a cycle ergometer to measure peak oxygen uptake.

What are the possible benefits and risks of participating?

Participants may experience improved physical fitness, which could lead to better surgical outcomes and reduced postoperative complications. The study will also provide insights into the relative effectiveness of hybrid prehabilitation, potentially offering more flexible options and facilitating access to care for future patients. Risks may include muscle soreness, fatigue, or injury related to exercise, independently of group allocation. All exercise sessions will be supervised or monitored to minimize these risks. Participants will receive instructions on how to perform exercises safely and will be encouraged to report any adverse effects promptly.

Conditions

• Non-Small Cell Lung Cancer

Interventions

OTHER

Hybrid prehabilitation

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 home-based sessions will mirror those in the center-based 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 for guidance throughout the program, remote monitoring and communication (TELEREHAPP). 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 with daily step count objective; * Regular remote monitoring and support via the tablet application, with weekly check-ins from healthcare professionals.

OTHER

Center-based prehabilitation

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), 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.

Sponsors & Collaborators

• Région Normandie

  collaborator OTHER_GOV

• Département de la Seine Maritime

  collaborator UNKNOWN

• European Union

  collaborator OTHER

• French-Speaking Association of Supportive Care in Cancer (AFSOS)

  collaborator UNKNOWN

• MSD France

  collaborator INDUSTRY

• Union des Kinésithérapeutes Respiratoires

  collaborator UNKNOWN

• ADIR Association

  lead OTHER

Principal Investigators

• Tristan Bonnevie, PhD · Association ADIR

• Fairuz Boujibar, PhD · Rouen University Hospital - Thoracic Surgery Department

• Francis-Edouard Gravier, PhD · Association ADIR

• Antoine Cuvelier, Prof · Association ADIR

• Jean-François Muir, Prof · Association ADIR

• David Debeaumont, MD · Rouen University Hospital - Department of Respiratory and Exercise Physiology

• Jean-Marc Baste, Prof · Rouen University Hospital - Thoracic Surgery Department

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-30

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• France

Study Locations