Protocol for Prehabilitation Service Implementation in Catalonia
- Conditions
- Chronic Disease
- Interventions
- Other: Trimodal Prehabilitation
- Registration Number
- NCT03767387
- Lead Sponsor
- Hospital Clinic of Barcelona
- Brief Summary
Trimodal prehabilitation consists of a short-term (\~ four to six weeks) preventive intervention to: i) enhance aerobic capacity and daily physical activity; ii) nutritional optimization; and, iii) psychological support before a major surgical procedure. The final aim of prehabilitation is to decrease surgical complications and speed-up postoperative functional recovery.
- Detailed Description
This is a preventive intervention addressed to high risk candidates for major surgical procedures carried out for a period of approximately four weeks before surgery aiming at reducing complications and enhancing post-surgical recovery. It combines: i) high-intensity endurance exercise training and promotion of daily physical activity; ii) nutritional balance; and, iii) psychological support.
The intervention is currently deployed as mainstream service at Hospital Clinic in several types of major surgeries. During fall 2017, three multidisciplinary workshops using a design-thinking approach were carried out to refine the service workflow and to explore the potential for service scalability. The outcomes of the co-design process provided a robust background for the design of a future personalized perioperative care service at regional level covering three phases: prehabilitation, in-patient care, and, post-discharge care.
The current study protocol aims to assess cost-effectiveness of prehabilitation as mainstream service in the ongoing deployment at Hospital Clinic, as well as to generate a roadmap for regional scalability of the service. It is planned as a quasi-experimental case-control study including 500 patients undertaking prehabilitation, as intervention group, and 250 patients following standard conventional care before surgery. The patients will be included from the following type of surgeries (2:1 intervention to control ratio): major digestive surgery (n, 525), lung volume reduction (n, 30), radical cystectomy (n, 30), major cardiovascular surgery (n, 165). Study groups will be made comparable using propensity score matching with the following matching variables: type of surgery, age, sex and adjusted morbidity groups (GMA) scoring.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 750
- Adult patients (>18 years old) candidates to colorectal surgery, esophagectomy, gastrectomy, gastric bypass, major liver resection, pancreas resection, lung volume resection, radical cystectomy, cardiac valve surgery or cardiac revascularization.
- Patients at high-risk for surgical complications defined by age > 70 years old and/or American Society of Anesthesiologists 3-4.
- Non-elective surgery
- Metastatic disease known preoperatively
- Unstable cardiac or respiratory disease
- Locomotor limitations precluding exercise performance
- Cognitive deterioration impeding adherence to the program
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prehabilitation + standard care Trimodal Prehabilitation Trimodal Prehabilitation consisting on motivation, personalisation and supervision of physical activity before major surgery
- Primary Outcome Measures
Name Time Method cost-effectiveness 4 weeks Health care costs
- Secondary Outcome Measures
Name Time Method Meters achieved in the six-minute walk test 4 weeks Aerobic capacity
Yale Physical Activity Survey (YPAS) 4 weeks Physical activity assessed by the YPAS (Range 0-100) Higher values represent better
Number of Emergency room visits 4 weeks 30-day emergency room visits rate
Psychological status assessed by the The Hospital Anxiety And Depression Scale (HAD) 4 weeks Psychological status (Range 0-21) Higher values represent worst
Complications 4 weeks number of complications per patient
Length of stay 4 weeks hospital and intensive care unit length of stay,
Health status assessed by 36-Item Short Form Survey (SF-36) 4 weeks Health status related quality of life (Range 0-100) Higher values represent better
Number of hospital readmissions 4 weeks 30-day hospital readmissions rate
Trial Locations
- Locations (1)
Hospital Clinic. Prehabilitation Unit D +34932275747 chernan@clinic.ub.es
🇪🇸Barcelona, Catalonia, Spain