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Protocol for Prehabilitation Service Implementation in Catalonia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03767387
Recruitment Status : Active, not recruiting
First Posted : December 6, 2018
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Josep Roca, 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.

Condition or disease Intervention/treatment Phase
Chronic Disease Other: Trimodal Prehabilitation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Protocol for Prehabilitation Service Implementation in Catalonia
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Prehabilitation + standard care
Trimodal Prehabilitation consisting on motivation, personalisation and supervision of physical activity before major surgery
Other: 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.

No Intervention: Standard care
Standard care before major surgery



Primary Outcome Measures :
  1. cost-effectiveness [ Time Frame: 4 weeks ]
    Health care costs


Secondary Outcome Measures :
  1. Complications [ Time Frame: 4 weeks ]
    number of complications per patient

  2. Length of stay [ Time Frame: 4 weeks ]
    hospital and intensive care unit length of stay,

  3. Number of hospital readmissions [ Time Frame: 4 weeks ]
    30-day hospital readmissions rate

  4. Number of Emergency room visits [ Time Frame: 4 weeks ]
    30-day emergency room visits rate

  5. Meters achieved in the six-minute walk test [ Time Frame: 4 weeks ]
    Aerobic capacity

  6. Yale Physical Activity Survey (YPAS) [ Time Frame: 4 weeks ]
    Physical activity assessed by the YPAS

  7. Health status assessed by 36-Item Short Form Survey (SF-36) [ Time Frame: 4 weeks ]
    Health status related quality of life

  8. Psychological status assessed by the The Hospital Anxiety And Depression Scale (HAD) [ Time Frame: 4 weeks ]
    Psychological status



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03767387


Locations
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Spain
Hospital Clinic. Prehabilitation Unit D +34932275747 chernan@clinic.ub.es
Barcelona, Catalonia, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
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Principal Investigator: Josep Roca, MD Hospital Clinic

Publications:
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Responsible Party: Josep Roca, Consultor Senior, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT03767387     History of Changes
Other Study ID Numbers: NEXTCARE-PREHAB
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Josep Roca, Hospital Clinic of Barcelona:
Prehabilitation
Physical Activity
Integrated Care
Collaborative Self-management
Additional relevant MeSH terms:
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Chronic Disease
Disease Attributes
Pathologic Processes