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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Change from baseline in peak oxygen uptake.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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.
研究组 & 干预措施
Hybrid prehabilitation
15 prehabilitation sessions divided into 3 center-based sessions and 12 home-based sessions.
干预措施: Hybrid prehabilitation (Other)
Centre-based prehabilitation.
15 center-based prehabilitation sessions.
干预措施: Center-based prehabilitation (Other)
结局指标
主要结局
Change from baseline in peak oxygen uptake.
时间窗: 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.
次要结局
- 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).)
- Change from baseline in expiratory muscle strength.(From enrollment to the end of prehabilitation (15 sessions, 3 weeks).)
- Change from baseline in symptoms of anxiety.(From enrollment to the end of prehabilitation (15sessions, 3weeks).)
- Change from baseline in peak expiratory flow.(From enrollment to the end of prehabilitation (15 sessions, 3 weeks).)
- Change from baseline in peak cough expiratory flow.(From enrollment to the end of prehabilitation (15sessions, 3weeks).)
- Change from baseline in quality of life.(From enrollment to the end of prehabilitation (15sessions, 3weeks).)
- Post-operative complications.(Thirty days following surgery.)
- Change from baseline in symptoms of depression.(From enrollment to the end of prehabilitation (15sessions, 3weeks).)
- Adherence(At the end of prehabilitation (3 weeks).)
- Clinically-relevant post-operative complications.(Thirty days following surgery.)
- Hospital length of stay following surgery(Thirty days following surgery.)
- Environmental impact(At the end of prehabilitation (3 weeks).)