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Completed

NCT Number: NCT03767387

Protocol for Prehabilitation Service Implementation in Catalonia

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clinic. Prehabilitation Unit D +34932275747 [email protected]

Barcelona, Catalonia, 08036, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. cost-effectiveness

    Time frame: 4 weeks

    Health care costs

Secondary outcomes

  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 (Range 0-100) Higher values represent better

  7. Health status assessed by 36-Item Short Form Survey (SF-36)

    Time frame: 4 weeks

    Health status related quality of life (Range 0-100) Higher values represent better

  8. Psychological status assessed by the The Hospital Anxiety And Depression Scale (HAD)

    Time frame: 4 weeks

    Psychological status (Range 0-21) Higher values represent worst

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 6, 2018
Registry last updated
Feb 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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