Protocol for Prehabilitation Service Implementation in Catalonia

NCT ID: NCT03767387

Last Updated: 2020-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 750 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2019-10-01

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.

Conditions

Chronic Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Prehabilitation + standard care

Trimodal Prehabilitation consisting on motivation, personalisation and supervision of physical activity before major surgery

Group Type: ACTIVE_COMPARATOR

Trimodal Prehabilitation

Intervention Type: OTHER

Prehabilitation before major surgery consisting of: i) motivational interview to assess patient's adherence profile and to co-design the characteristics of the physical activity program with the patient; ii) personalised program to promote daily physical activity; and iii) supervised high-intensity endurance exercise training program.

Standard care

Standard care before major surgery

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Trimodal Prehabilitation

Prehabilitation before major surgery consisting of: i) motivational interview to assess patient's adherence profile and to co-design the characteristics of the physical activity program with the patient; ii) personalised program to promote daily physical activity; and iii) supervised high-intensity endurance exercise training program.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Non-elective surgery
• Metastatic disease known preoperatively
• Unstable cardiac or respiratory disease
• Locomotor limitations precluding exercise performance
• Cognitive deterioration impeding adherence to the program

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Clinic of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Josep Roca

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Josep Roca, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic

Locations

Hospital Clinic. Prehabilitation Unit D +34932275747 chernan@clinic.ub.es

Barcelona, Catalonia, Spain

Countries

Spain

References

Barberan-Garcia A, Ubre M, Roca J, Lacy AM, Burgos F, Risco R, Momblan D, Balust J, Blanco I, Martinez-Palli G. Personalised Prehabilitation in High-risk Patients Undergoing Elective Major Abdominal Surgery: A Randomized Blinded Controlled Trial. Ann Surg. 2018 Jan;267(1):50-56. doi: 10.1097/SLA.0000000000002293.

Reference Type: BACKGROUND

PMID: 28489682 (View on PubMed)

Other Identifiers

NEXTCARE-PREHAB

Identifier Type: -

Identifier Source: org_study_id