About this trial
The PROPOSE RCT is a two-arm randomized controlled trial that will be conducted to test the efficacy of a personalized, multidisciplinary pre-operative prehabilitation program (preventive prehabilitation) to reduce serious complications and facilitate recovery after surgery in high-risk patients.
The multimodal prehabilitation program is a preoperative intervention that includes exercise training, nutritional therapy and anxiety reduction techniques, with the aim of preventing or mitigating the functional decline brought about by surgery. 400 patients scheduled for elective major abdominal (including urological), thoracic (including breast) or gynecological cancer surgery will be enrolled. They will be randomized (1:1 ratio) and assigned either to the intervention group (Prehabilitation) or to the control group, which will only be treated according to the usual standard of care within the Enhanced Recovery After Surgery (ERAS) pathways.
Eligibility criteria
Qualifiers
Adult patient (age > 18 years);
Scheduled for elective major abdominal (including urological), thoracic (including breast) or gynecological cancer surgery;
Signed informed consent.
Disqualifiers
Acute or unstable cardio-respiratory conditions (e.g., unstable angina or symptomatic severe aortic stenosis);
Severe/end-stage organ diseases (e.g., cardiac failure NYHA functional classes III-IV, COPD FEV1 <50% pred, end-stage kidney or liver disease);
American Society of Anesthesiologists (ASA) physical status classes 4-5;
Disabling orthopedic and neuromuscular disease;
Trial design
Treatments tested in this trial
- Multimodal prehabilitation Program
Treatment groups
Sponsors and collaborators
Università Vita-Salute San Raffaele
Lead sponsor
Prof. Pasquale Sansone
Collaborator
Prof. Eugenio Garofalo
Collaborator
Prof. Tiziana Bove
Collaborator
Dr. Claudia Brusasco
Collaborator
Prof. Gabriele Baldini
Collaborator
Dr. Nicola Passuello
Collaborator
Dr. Monica Gualtierotti
Collaborator
Prof. Luca Carlo Nespoli
Collaborator