Protocol for Prehabilitation Service Implementation in Catalonia

NCT03767387 | Completed DMC

• 1 other identifier: NEXTCARE-PREHAB
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Disease

Keywords

Prehabilitation; Physical Activity; Integrated Care; Collaborative Self-management

Outcome Measures

Primary Outcomes (1)

• cost-effectiveness

  Health care costs

  4 weeks

Secondary Outcomes (8)

• Complications

  4 weeks

• Length of stay

  4 weeks

• Number of hospital readmissions

  4 weeks

• Number of Emergency room visits

  4 weeks

• Meters achieved in the six-minute walk test

  4 weeks

Study Arms (2)

Prehabilitation + standard care

ACTIVE COMPARATOR

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

Other: Trimodal Prehabilitation

Standard care

NO INTERVENTION

Standard care before major surgery

Interventions

Trimodal Prehabilitation 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.

Prehabilitation + standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

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

Barcelona, Catalonia, 08036, Spain

Location

Related Publications (1)

• 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.

  PMID: 28489682 BACKGROUND

MeSH Terms

Conditions

Chronic Disease; Motor Activity

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Josep Roca, MD

  Hospital Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 6, 2018
• Study Start: November 1, 2018
• Primary Completion: August 1, 2019
• Study Completion: October 1, 2019
• Last Updated: February 13, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)