Non-Small Cell Lung CancerHYBREATHNCT06866717
Hybrid Prehabilitation Before Thoracic Surgery
A study testing Hybrid prehabilitation and Center-based prehabilitation in people with Non-Small Cell Lung Cancer, run by ADIR Association at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Hybrid prehabilitation and Center-based prehabilitation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- 30 May 2025to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Surgery date not established at the time of inclusion in the program, or at least 4 weeks away
- Peak oxygen uptake below 20 ml/kg/min
Show all 15Show fewer
- Affiliated with a health insurance system
- Able to read and understand the information letter and sign the consent form
- Non-Inclusion Criteria:
- Oxygen therapy during exercise
- Cardiological contraindication to exercise training
- 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
Who cannot join
- -Withdrawal of consent
- The eligibility criteria were revised in May 2026 following approval of a protocol amendment by the French Ethics Committee (CPP Île-de-France IV). The former non-inclusion criterion of patients receiving concomitant neoadjuvant chemoradiotherapy was removed to better reflect the study population to current clinical practice, as neoadjuvant treatments are increasingly integrated into the care pathway of patients undergoing thoracic surgery for non-small cell lung cancer and referred for pulmonary prehabilitation. The previous restriction had been too limiting and had slowed recruitment. This amendment was proposed to improve the feasibility of recruitment and to increase the representativeness of the study population, while ensuring the safety of the participants as no additional safety concerns were identified and all other exclusion criteria related to safety were unchanged.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Association ADIR
Rouen, 76000
Tristan Bonnevie, PhD, 0235592970 ext. +33, t.bonnevie@adir-hautenormandie.com
About this study
Official title: Relative Effectiveness of a Hybrid Prehabilitation Program (Home-based and Center-based) Compared to a Center-based Prehabilitation Program Before Non-small Cell Lung Cancer Surgery: A Randomized Controlled Equivalence Study
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.
Read more
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.
Read the detailed description
Lung cancer is a leading cause of cancer-related mortality worldwide. Surgical resection is the primary curative treatment for early-stage non-small cell lung cancer; however, patients often present with compromised physical fitness, which can adversely affect surgical outcomes and postoperative recovery.
Prehabilitation, the process of enhancing a patient's functional capacity before surgery, has emerged as a promising strategy to improve surgical outcomes. Studies have demonstrated that prehabilitation can lead to reductions in postoperative complications, shorter hospital stays, and improved quality of life.
Prehabilitation programs are typically conducted in specialized clinical settings, which may limit accessibility and adherence. Hybrid models that combine home-based and center-based interventions may offer the opportunity for a more flexible option and may address the limited access to specialized care for many patients.
This study primarily aims to evaluate the relative effectiveness of a hybrid prehabilitation program of 15 sessions (incorporating both home-based and center-based components) compared to a center-based prehabilitation program of 15 sessions in patients undergoing surgery for non-small cell lung cancer on the change in oxygen uptake.
The study also aims to evaluate the relative effectiveness of a hybrid prehabilitation program of 15 sessions (incorporating both home-based and center-based components) compared to a center-based prehabilitation program of 15 sessions in patients undergoing surgery for non-small cell lung cancer on the change in peak power output, ventilatory efficiency, functional capacity, quadriceps muscle maximal isometric strength, respiratory muscle strength, maximal peak expiratory flow and cough expiratory flow, quality of life, psychological status as well as adherence, postoperative complications, clinically relevant postoperative complications, length of hospital stay, and environmental impact.
Study design:
This is a prospective, monocentric, randomized controlled equivalence trial with concealed allocation and a single-blind design (blinded evaluator). Participants will be randomly assigned to one of two groups:
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), balance training, 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.
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 center-based sessions will mirror those in the center-based prehabilitation 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 (TELEREHAPP) for guidance throughout the program, remote monitoring, and communication. 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, including a daily step goal.
Regular remote monitoring and support via the tablet application, with weekly check-ins from healthcare professionals.
Sample size calculation for equivalence study:
Assuming a mean change difference in peak oxygen uptake between the two groups of 0 ml/kg/min, a significance level (alpha) of 0.05, a power of 80%, an equivalence margin of 1.75 ml/kg/min, and a standard deviation of 1.8 ml/kg/min for the change in peak oxygen uptake after a condensed rehabilitation program of 5 sessions per week during 3 weeks, we plan to recruit 19 patients per group, totaling 38 patients.
Statistical analysis:
Categorical data will be presented as counts (percentages). Continuous descriptive data will be expressed as means (SD) or medians (IQR), depending on their distribution. The normality of distributions will be assessed using the Kolmogorov-Smirnov test.
Intergroup differences will be reported as mean differences (95% confidence intervals). Non-parametric data will be converted to means (SD) using an appropriate method. Results will be interpreted based on the span of the 95% confidence intervals relative to pre-specified outcomes (see Outcome Measures section).
The relative effect of interventions on categorical data will be examined using relative risk (95% confidence intervals).
Statistical analyses will be conducted on an intention-to-treat basis, using the last available observation for preoperative assessment criteria and considering the absence of complications for postoperative complications (for patients who will not ultimately be operated).
A secondary per-protocol analysis will be performed.
A sensitivity analysis will be conducted by including baseline values as a covariate in the model.
Analyses will be performed using GraphPad 8 and R software.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Hybrid prehabilitation, Center-based prehabilitation
- Keywords
- Non-small cell lung cancer, Prehabilitation, Telerehabilitation, Hybrid prehabilitation, Home-base exercise training
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid prehabilitationOther
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 prehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Hybrid prehabilitation | Experimental | 15 prehabilitation sessions divided into 3 center-based sessions and 12 home-based sessions. Receives: Other: Hybrid prehabilitation |
| Centre-based prehabilitation. | Active comparator | 15 center-based prehabilitation sessions. Receives: Other: Center-based prehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of prehabilitation (15 sessions, 3 weeks).
Secondary outcomes (16)
Change from baseline in peak power output.
Change in peak power output 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 4 watts.
Measured: From enrollment to the end of prehabilitation (15 sessions, 3 weeks).
Change from baseline in ventilatory efficiency.
Change in ventilatory efficiency will be assessed during an incremental cardiopulmonary exercise testing on a cycle ergometer before and after the prehabilitation program.Ventilatory efficiency will be calculated as the ratio of minute ventilation to carbon dioxide production.
Measured: From enrollment to the end of prehabilitation (15 sessions, 3 weeks).
Change from baseline in functional capacity.
Change in functional capacity will be assessed using the one-minute-sit-to-stand test before and after the prehabilitation program. Performance during the one-minute-sit-to-stand test will be reported as the number of lifts during the test. The pre-specified minimal clinically important difference is set at 3 lifts.
Measured: From enrollment to the end of prehabilitation (15 sessions, 3 weeks).
Change from baseline in quadriceps muscle isometric strength.
Change in maximum voluntary quadriceps muscle isometric strength will be assessed by dynamometry before and after the prehabilitation program. The pre-specified minimal clinically important difference is set at 7.5 Nm.
Measured: From enrollment to the end of prehabilitation (15 sessions, 3 weeks).
Change from baseline in inspiratory muscle strength.
Change in inspiratory muscle strength will be assessed as maximal inspiratory pressure using manometry before and after the prehabilitation program. The pre-specified minimal clinically important difference is set at 13.5 cm H2O.
Measured: From enrollment to the end of prehabilitation (15 sessions, 3 weeks).
Change from baseline in expiratory muscle strength.
Change in expiratory muscle strength will be assessed as maximal expiratory pressure using manometry before and after the prehabilitation program.
Measured: From enrollment to the end of prehabilitation (15 sessions, 3 weeks).
Change from baseline in peak expiratory flow.
Change in peak expiratory flow will be assessed by flow meter during maximal expiratory effort before and after the prehabilitation program.
Measured: From enrollment to the end of prehabilitation (15 sessions, 3 weeks).
Change from baseline in peak cough expiratory flow.
Change in peak cough expiratory flow will be assessed by flow meter during maximal cough effort before and after the prehabilitation program.
Measured: From enrollment to the end of prehabilitation (15sessions, 3weeks).
Change from baseline in quality of life.
Change in quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30) and its Lung Cancer module (LC 13) before and after the prehabilitation program. Scores range from 0 to 100 with a higher score reflecting either better function or milder symptoms. The pre-specified minimal clinically important difference is set at +3 points for improvement and -6 points for deterioration.
Measured: From enrollment to the end of prehabilitation (15sessions, 3weeks).
Change from baseline in symptoms of anxiety.
Change in symptoms of anxiety will be assessed using the Hospital Anxiety and Depression questionnaire, anxiety subscore, before and after the prehabilitation program. The score ranges from 0 (best) to 21 (worst). The pre-specified minimal clinically important difference is set at -1.5 point.
Measured: From enrollment to the end of prehabilitation (15sessions, 3weeks).
Change from baseline in symptoms of depression.
Change in symptoms of depression will be assessed using the Hospital Anxiety and Depression questionnaire, depression subscore, before and after the prehabilitation program. The score ranges from 0 (best) to 21 (worst). The pre-specified minimal clinically important difference is set at -1.5 point.
Measured: From enrollment to the end of prehabilitation (15sessions, 3weeks).
Adherence
Adherence will be assessed as the ratio of completed sessions to prescribed sessions (15 sessions).
Measured: At the end of prehabilitation (3 weeks).
Post-operative complications.
Post-operative complications at 30 days following surgery will be assessed using the Clavien-Dindo classification. The pre-specified minimal clinically important difference between groups is set at 30%.
Measured: Thirty days following surgery.
Clinically-relevant post-operative complications.
Post-operative complications at 30 days following surgery will be assessed using the Clavien-Dindo classification. Complications with a score equal or superior to two on this classification will be considered as clinically-relevant. The pre-specified minimal clinically important difference between groups is set at 30%.
Measured: Thirty days following surgery.
Hospital length of stay following surgery
Hospital length of stay following surgery will be assessed as the number of days between surgery and discharge.
Patient discharge is confirmed after validation of all the following items:
Patient discharge is confirmed after validation of all the following items:
- Patient is autonomous in eating, dressing, and toileting.
- Autonomous in getting out of bed.
- Autonomous in personal hygiene.
- Autonomous in using the toilet.
- Patient is able to walk 50 meters without desaturation below 90% (or return to -preoperative state).
- Patient is able to climb and descend one flight of stairs without desaturation below 90% (or return to preoperative state).
- Satisfactory wound healing.
The pre-specified minimal clinically important difference is set at 1 day.
Measured: Thirty days following surgery.
Environmental impact
The environmental impact will be assessed using the Climate Partner Hub software (Climate Partner®, Munich, Germany). The assessment will include a Life Cycle Assessment for each device used in both groups, data transmission and storage on cloud servers for hybrid prehabilitation, and transportation for both groups.
Measured: At the end of prehabilitation (3 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start30 May 2025
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, randomized controlled equivalence trial with concealed allocation, a blinded assessor, and an intention-to-treat analysis.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ADIR Association
- Sponsor type
- University, hospital or other
- Collaborators
- Région Normandie, Département de la Seine Maritime, European Union, French-Speaking Association of Supportive Care in Cancer (AFSOS), MSD France, Union des Kinésithérapeutes Respiratoires
- Responsible party
- Sponsor
- Investigators
- Tristan Bonnevie, PhD, Principal investigator, Association ADIRFairuz Boujibar, PhD, Study chair, Rouen University Hospital - Thoracic Surgery DepartmentFrancis-Edouard Gravier, PhD, Study chair, Association ADIRAntoine Cuvelier, Prof, Study chair, Association ADIRJean-François Muir, Prof, Study chair, Association ADIRDavid Debeaumont, MD, Study chair, Rouen University Hospital - Department of Respiratory and Exercise PhysiologyJean-Marc Baste, Prof, Study chair, Rouen University Hospital - Thoracic Surgery Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06866717
- Sponsor's protocol ID
- HYBREATH
- Acronym
- HYBREATH
- Status last verified
- May 2026
- First submitted
- 19 Feb 2025
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available upon reasonable request for research purposes after publication. This includes de-identified data related to demographic characteristics, as well as endpoints published either in the main manuscript or any supplemental data. Requests should be sent to t.bonnevie@adir-hautenormandie.com
Publications
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.
PubMed 34952813
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Effectiveness of a Hybrid Prehabilitation Program (Home-based and Center-based) Compared to a Center-based Prehabilitation Program Before Non-small Cell Lung Cancer Surgery: A Randomized Controlled Equivalence Study
- ClinicalTrials.gov ID
- NCT06866717
- Acronym / sponsor ID
- HYBREATH / HYBREATH
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Non-small cell lung cancer, Prehabilitation, Telerehabilitation, Hybrid prehabilitation, Home-base exercise training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- ADIR AssociationUniversity, hospital or other
- Collaborators
- Région Normandie, Département de la Seine Maritime, European Union, French-Speaking Association of Supportive Care in Cancer (AFSOS), MSD France, Union des Kinésithérapeutes Respiratoires
- Study start
- 30 May 2025 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Lung cancer is a leading cause of cancer-related mortality worldwide. Surgical resection is the primary curative treatment for early-stage non-small cell lung cancer; however, patients often present with compromised physical fitness, which can adversely affect surgical outcomes and postoperative recovery.
Prehabilitation, the process of enhancing a patient's functional capacity before surgery, has emerged as a promising strategy to improve surgical outcomes. Studies have demonstrated that prehabilitation can lead to reductions in postoperative complications, shorter hospital stays, and improved quality of life.
Prehabilitation programs are typically conducted in specialized clinical settings, which may limit accessibility and adherence. Hybrid models that combine home-based and center-based interventions may offer the opportunity for a more flexible option and may address the limited access to specialized care for many patients.
This study primarily aims to evaluate the relative effectiveness of a hybrid prehabilitation program of 15 sessions (incorporating both home-based and center-based components) compared to a center-based prehabilitation program of 15 sessions in patients undergoing surgery for non-small cell lung cancer on the change in oxygen uptake.
The study also aims to evaluate the relative effectiveness of a hybrid prehabilitation program of 15 sessions (incorporating both home-based and center-based components) compared to a center-based prehabilitation program of 15 sessions in patients undergoing surgery for non-small cell lung cancer on the change in peak power output, ventilatory efficiency, functional capacity, quadriceps muscle maximal isometric strength, respiratory muscle strength, maximal peak expiratory flow and cough expiratory flow, quality of life, psychological status as well as adherence, postoperative complications, clinically relevant postoperative complications, length of hospital stay, and environmental impact.
Study design:
This is a prospective, monocentric, randomized controlled equivalence trial with concealed allocation and a single-blind design (blinded evaluator). Participants will be randomly assigned to one of two groups:
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), balance training, 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.
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 center-based sessions will mirror those in the center-based prehabilitation 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 (TELEREHAPP) for guidance throughout the program, remote monitoring, and communication. 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, including a daily step goal.
Regular remote monitoring and support via the tablet application, with weekly check-ins from healthcare professionals.
Sample size calculation for equivalence study:
Assuming a mean change difference in peak oxygen uptake between the two groups of 0 ml/kg/min, a significance level (alpha) of 0.05, a power of 80%, an equivalence margin of 1.75 ml/kg/min, and a standard deviation of 1.8 ml/kg/min for the change in peak oxygen uptake after a condensed rehabilitation program of 5 sessions per week during 3 weeks, we plan to recruit 19 patients per group, totaling 38 patients.
Statistical analysis:
Categorical data will be presented as counts (percentages). Continuous descriptive data will be expressed as means (SD) or medians (IQR), depending on their distribution. The normality of distributions will be assessed using the Kolmogorov-Smirnov test.
Intergroup differences will be reported as mean differences (95% confidence intervals). Non-parametric data will be converted to means (SD) using an appropriate method. Results will be interpreted based on the span of the 95% confidence intervals relative to pre-specified outcomes (see Outcome Measures section).
The relative effect of interventions on categorical data will be examined using relative risk (95% confidence intervals).
Statistical analyses will be conducted on an intention-to-treat basis, using the last available observation for preoperative assessment criteria and considering the absence of complications for postoperative complications (for patients who will not ultimately be operated).
A secondary per-protocol analysis will be performed.
A sensitivity analysis will be conducted by including baseline values as a covariate in the model.
Analyses will be performed using GraphPad 8 and R software.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single-center, randomized controlled equivalence trial with concealed allocation, a blinded assessor, and an intention-to-treat analysis.
| Arm | Type | Receives |
|---|---|---|
| Hybrid prehabilitation | Experimental | Other: Hybrid prehabilitation15 prehabilitation sessions divided into 3 center-based sessions and 12 home-based sessions. |
| Centre-based prehabilitation. | Active comparator | Other: Center-based prehabilitation15 center-based prehabilitation sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
- Surgery date not established at the time of inclusion in the program, or at least 4 weeks away
Key exclusion criteria (2 listed)
- -Withdrawal of consent
- The eligibility criteria were revised in May 2026 following approval of a protocol amendment by the French Ethics Committee (CPP Île-de-France IV). The former non-inclusion criterion of patients receiving concomitant neoadjuvant chemoradiotherapy was removed to better reflect the study population to current clinical practice, as neoadjuvant treatments are increasingly integrated into the care pathway of patients undergoing thoracic surgery for non-small cell lung cancer and referred for pulmonary prehabilitation. The previous restriction had been too limiting and had slowed recruitment. This amendment was proposed to improve the feasibility of recruitment and to increase the representativeness of the study population, while ensuring the safety of the participants as no additional safety concerns were identified and all other exclusion criteria related to safety were unchanged.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hybrid prehabilitationHybrid 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 | Hybrid prehabilitation |
| Center-based prehabilitationCenter-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. | Other | Centre-based prehabilitation. |
Primary outcome
Change from baseline in peak oxygen uptake.
Time frame: From enrollment to the end of prehabilitation (15 sessions, 3 weeks).
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.
16 secondary outcomes
Change from baseline in peak power output.
Time frame: From enrollment to the end of prehabilitation (15 sessions, 3 weeks).
Change from baseline in ventilatory efficiency.
Time frame: From enrollment to the end of prehabilitation (15 sessions, 3 weeks).
Change from baseline in functional capacity.
Time frame: From enrollment to the end of prehabilitation (15 sessions, 3 weeks).
Change from baseline in quadriceps muscle isometric strength.
Time frame: From enrollment to the end of prehabilitation (15 sessions, 3 weeks).
Change from baseline in inspiratory muscle strength.
Time frame: From enrollment to the end of prehabilitation (15 sessions, 3 weeks).
Change from baseline in expiratory muscle strength.
Time frame: From enrollment to the end of prehabilitation (15 sessions, 3 weeks).
Change from baseline in peak expiratory flow.
Time frame: From enrollment to the end of prehabilitation (15 sessions, 3 weeks).
Change from baseline in peak cough expiratory flow.
Time frame: From enrollment to the end of prehabilitation (15sessions, 3weeks).
Change from baseline in quality of life.
Time frame: From enrollment to the end of prehabilitation (15sessions, 3weeks).
Change from baseline in symptoms of anxiety.
Time frame: From enrollment to the end of prehabilitation (15sessions, 3weeks).
Change from baseline in symptoms of depression.
Time frame: From enrollment to the end of prehabilitation (15sessions, 3weeks).
Adherence
Time frame: At the end of prehabilitation (3 weeks).
Post-operative complications.
Time frame: Thirty days following surgery.
Clinically-relevant post-operative complications.
Time frame: Thirty days following surgery.
Hospital length of stay following surgery
Time frame: Thirty days following surgery.
Environmental impact
Time frame: At the end of prehabilitation (3 weeks).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Results publication: PubMed 34952813Gravier 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.
- Individual participant dataSharing planned: Yes. Data will be made available upon reasonable request for research purposes after publication. This includes de-identified data related to demographic characteristics, as well as endpoints published either in the main manuscript or any supplemental data. Requests should be sent to t.bonnevie@adir-hautenormandie.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tristan Bonnevie, PhD principal investigator
Association ADIR
Fairuz Boujibar, PhD study chair
Rouen University Hospital - Thoracic Surgery Department
Francis-Edouard Gravier, PhD study chair
Association ADIR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid prehabilitation and Center-based prehabilitation in people with Non-Small Cell Lung Cancer, run by ADIR Association at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tristan Bonnevie, PhD (0235592970 ext. +33, t.bonnevie@adir-hautenormandie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in peak oxygen uptake. (time frame: From enrollment to the end of prehabilitation (15 sessions, 3 weeks).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06866717, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026; AzTrials last refreshed its copy on 30 Oct 2026.