Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06866717

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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