Hybrid Prehabilitation Before Thoracic Surgery

NCT06866717 | Recruiting

• 1 other identifier: HYBREATH
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Non-small cell lung cancer; Prehabilitation; Telerehabilitation; Hybrid prehabilitation; Home-base exercise training

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of prehabilitation (15 sessions, 3 weeks).

Secondary Outcomes (16)

• Change from baseline in peak power output.

  From enrollment to the end of prehabilitation (15 sessions, 3 weeks).

• Change from baseline in ventilatory efficiency.

  From enrollment to the end of prehabilitation (15 sessions, 3 weeks).

• Change from baseline in functional capacity.

  From enrollment to the end of prehabilitation (15 sessions, 3 weeks).

• Change from baseline in quadriceps muscle isometric strength.

  From enrollment to the end of prehabilitation (15 sessions, 3 weeks).

• Change from baseline in inspiratory muscle strength.

  From enrollment to the end of prehabilitation (15 sessions, 3 weeks).

Study Arms (2)

Hybrid prehabilitation

EXPERIMENTAL

15 prehabilitation sessions divided into 3 center-based sessions and 12 home-based sessions.

Other: Hybrid prehabilitation

Centre-based prehabilitation.

ACTIVE COMPARATOR

15 center-based prehabilitation sessions.

Other: Center-based prehabilitation

Interventions

Hybrid prehabilitation OTHER

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.

Hybrid prehabilitation

Center-based prehabilitation OTHER

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.

Centre-based prehabilitation.

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
• 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
• Peak oxygen uptake below 20 ml/kg/min
• Affiliated with a health insurance system
• Able to read and understand the information letter and sign the consent form
• Oxygen therapy during exercise
• Cardiological contraindication to exercise training
• Concomitant neoadjuvant chemoradiotherapy
• Refusal to participate in a center-based prehabilitation training program
• Orthopedic, neurological, vascular, or neuromuscular conditions limiting exercise training on a cycle ergometer
• Patient under guardianship or curatorship
• Pregnant or breastfeeding women

You may not qualify if:

• Withdrawal of consent

Sponsors & Collaborators

• ADIR Association: lead
• Région Normandie: collaborator
• Département de la Seine Maritime: collaborator
• European Union: collaborator
• French-Speaking Association of Supportive Care in Cancer (AFSOS): collaborator
• MSD France: collaborator
• Union des Kinésithérapeutes Respiratoires: collaborator

Study Sites (1)

Association ADIR

Rouen, 76000, France

RECRUITING

Related Publications (1)

• Gravier FE, Smondack P, Boujibar F, Prieur G, Medrinal C, Combret Y, Muir JF, Baste JM, Cuvelier A, Debeaumont D, Bonnevie T. Prehabilitation sessions can be provided more frequently in a shortened regimen with similar or better efficacy in people with non-small cell lung cancer: a randomised trial. J Physiother. 2022 Jan;68(1):43-50. doi: 10.1016/j.jphys.2021.12.010. Epub 2021 Dec 21.

  PMID: 34952813 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Tristan Bonnevie, PhD

  Association ADIR

  PRINCIPAL INVESTIGATOR

• Fairuz Boujibar, PhD

  Rouen University Hospital - Thoracic Surgery Department

  STUDY CHAIR

• Francis-Edouard Gravier, PhD

  Association ADIR

  STUDY CHAIR

• Antoine Cuvelier, Prof

  Association ADIR

  STUDY CHAIR

• Jean-François Muir, Prof

  Association ADIR

  STUDY CHAIR

• David Debeaumont, MD

  Rouen University Hospital - Department of Respiratory and Exercise Physiology

  STUDY CHAIR

• Jean-Marc Baste, Prof

  Rouen University Hospital - Thoracic Surgery Department

  STUDY CHAIR

Central Study Contacts

Tristan Bonnevie, PhD

CONTACT

0235592970; t.bonnevie@adir-hautenormandie.com

Study Design

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

Model Details: Single-center, randomized controlled equivalence trial with concealed allocation, a blinded assessor, and an intention-to-treat analysis.

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: March 10, 2025
• Study Start: May 30, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be made available after publication.
• Access Criteria: Data will be made available upon request, for research purpose. Request should be send to t.bonnevie@adir-hautenormandie.com

Locations

FR (1)