Hybrid Prehabilitation Before Thoracic Surgery

ConditionNon-Small Cell Lung Cancer

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorADIR Association

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 18 years

Patient scheduled to undergo lung resection for the treatment of diagnosed or suspected bronchial cancer

Referred for prehabilitation before lung resection surgery

Patient living at home with another adult present during exercise sessions

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

Hybrid prehabilitation
Other intervention
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.
Center-based prehabilitation
Other intervention
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.

Treatment groups

38 Participants

are divided into 2 treatment groups

Group A: Hybrid prehabilitationExperimental treatment 1 intervention

Group B: Centre-based prehabilitation.Active comparator 1 intervention

Trial outcomes

Primary outcomes

Change from baseline in peak oxygen uptake.

Change in peak oxygen uptake will be assessed during an incremental cardiopulmonary exercise testing on a cycle ergometer before and after the prehabilitation program. The pre-specified minimal clinically important difference is set at 1.75ml/kg/min.

Time frame