Actively Recruiting
Hybrid Prehabilitation Before Thoracic Surgery
Led by ADIR Association · Updated on 2025-06-15
38
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
Sponsors
A
ADIR Association
Lead Sponsor
R
Région Normandie
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Hybrid Prehabilitation Before Thoracic Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Scheduled for lung resection to treat diagnosed or suspected bronchial cancer
- Referred for prehabilitation before lung surgery
- Living at home with another adult present during exercises
- Surgery date not yet set or at least 4 weeks away
- Peak oxygen uptake below 20 ml/kg/min
- Covered by a health insurance system
- Able to read, understand information, and sign consent form
You will not qualify if you...
- Receiving oxygen therapy during exercise
- Cardiological contraindication to exercise training
- Undergoing neoadjuvant chemoradiotherapy
- Refusing participation in center-based prehabilitation
- Having orthopedic, neurological, vascular, or neuromuscular conditions limiting cycle ergometer exercise
- Under guardianship or curatorship
- Pregnant or breastfeeding
- Withdrawal of consent
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Trial Site Locations
Total: 1 location
1
Association ADIR
Rouen, France, 76000
Actively Recruiting
Research Team
T
Tristan Bonnevie, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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