<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03767387</url>
  </required_header>
  <id_info>
    <org_study_id>NEXTCARE-PREHAB</org_study_id>
    <nct_id>NCT03767387</nct_id>
  </id_info>
  <brief_title>Protocol for Prehabilitation Service Implementation in Catalonia</brief_title>
  <official_title>Protocol for Prehabilitation Service Implementation in Catalonia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Clinic of Barcelona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Clinic of Barcelona</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Trimodal prehabilitation consists of a short-term (~ four to six weeks) preventive&#xD;
      intervention to: i) enhance aerobic capacity and daily physical activity; ii) nutritional&#xD;
      optimization; and, iii) psychological support before a major surgical procedure. The final&#xD;
      aim of prehabilitation is to decrease surgical complications and speed-up postoperative&#xD;
      functional recovery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a preventive intervention addressed to high risk candidates for major surgical&#xD;
      procedures carried out for a period of approximately four weeks before surgery aiming at&#xD;
      reducing complications and enhancing post-surgical recovery. It combines: i) high-intensity&#xD;
      endurance exercise training and promotion of daily physical activity; ii) nutritional&#xD;
      balance; and, iii) psychological support.&#xD;
&#xD;
      The intervention is currently deployed as mainstream service at Hospital Clinic in several&#xD;
      types of major surgeries. During fall 2017, three multidisciplinary workshops using a&#xD;
      design-thinking approach were carried out to refine the service workflow and to explore the&#xD;
      potential for service scalability. The outcomes of the co-design process provided a robust&#xD;
      background for the design of a future personalized perioperative care service at regional&#xD;
      level covering three phases: prehabilitation, in-patient care, and, post-discharge care.&#xD;
&#xD;
      The current study protocol aims to assess cost-effectiveness of prehabilitation as mainstream&#xD;
      service in the ongoing deployment at Hospital Clinic, as well as to generate a roadmap for&#xD;
      regional scalability of the service. It is planned as a quasi-experimental case-control study&#xD;
      including 500 patients undertaking prehabilitation, as intervention group, and 250 patients&#xD;
      following standard conventional care before surgery. The patients will be included from the&#xD;
      following type of surgeries (2:1 intervention to control ratio): major digestive surgery (n,&#xD;
      525), lung volume reduction (n, 30), radical cystectomy (n, 30), major cardiovascular surgery&#xD;
      (n, 165). Study groups will be made comparable using propensity score matching with the&#xD;
      following matching variables: type of surgery, age, sex and adjusted morbidity groups (GMA)&#xD;
      scoring.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Actual">October 1, 2019</completion_date>
  <primary_completion_date type="Actual">August 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>cost-effectiveness</measure>
    <time_frame>4 weeks</time_frame>
    <description>Health care costs</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>4 weeks</time_frame>
    <description>number of complications per patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay</measure>
    <time_frame>4 weeks</time_frame>
    <description>hospital and intensive care unit length of stay,</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of hospital readmissions</measure>
    <time_frame>4 weeks</time_frame>
    <description>30-day hospital readmissions rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Emergency room visits</measure>
    <time_frame>4 weeks</time_frame>
    <description>30-day emergency room visits rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Meters achieved in the six-minute walk test</measure>
    <time_frame>4 weeks</time_frame>
    <description>Aerobic capacity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Yale Physical Activity Survey (YPAS)</measure>
    <time_frame>4 weeks</time_frame>
    <description>Physical activity assessed by the YPAS (Range 0-100) Higher values represent better</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health status assessed by 36-Item Short Form Survey (SF-36)</measure>
    <time_frame>4 weeks</time_frame>
    <description>Health status related quality of life (Range 0-100) Higher values represent better</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological status assessed by the The Hospital Anxiety And Depression Scale (HAD)</measure>
    <time_frame>4 weeks</time_frame>
    <description>Psychological status (Range 0-21) Higher values represent worst</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">750</enrollment>
  <condition>Chronic Disease</condition>
  <arm_group>
    <arm_group_label>Prehabilitation + standard care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Trimodal Prehabilitation consisting on motivation, personalisation and supervision of physical activity before major surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard care before major surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Trimodal Prehabilitation</intervention_name>
    <description>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.</description>
    <arm_group_label>Prehabilitation + standard care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (&gt;18 years old) candidates to colorectal surgery, esophagectomy,&#xD;
             gastrectomy, gastric bypass, major liver resection, pancreas resection, lung volume&#xD;
             resection, radical cystectomy, cardiac valve surgery or cardiac revascularization.&#xD;
&#xD;
          -  Patients at high-risk for surgical complications defined by age &gt; 70 years old and/or&#xD;
             American Society of Anesthesiologists 3-4.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-elective surgery&#xD;
&#xD;
          -  Metastatic disease known preoperatively&#xD;
&#xD;
          -  Unstable cardiac or respiratory disease&#xD;
&#xD;
          -  Locomotor limitations precluding exercise performance&#xD;
&#xD;
          -  Cognitive deterioration impeding adherence to the program&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Josep Roca, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Clinic. Prehabilitation Unit D +34932275747 chernan@clinic.ub.es</name>
      <address>
        <city>Barcelona</city>
        <state>Catalonia</state>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>28489682</PMID>
  </reference>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>February 11, 2020</last_update_submitted>
  <last_update_submitted_qc>February 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Clinic of Barcelona</investigator_affiliation>
    <investigator_full_name>Josep Roca</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Prehabilitation</keyword>
  <keyword>Physical Activity</keyword>
  <keyword>Integrated Care</keyword>
  <keyword>Collaborative Self-management</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03767387
org study id: NEXTCARE-PREHAB
nct id: NCT03767387
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: cost-effectiveness
time frame: 4 weeks
description: Health care costs
measure: Complications
time frame: 4 weeks
description: number of complications per patient
measure: Length of stay
time frame: 4 weeks
description: hospital and intensive care unit length of stay,
measure: Number of hospital readmissions
time frame: 4 weeks
description: 30-day hospital readmissions rate
measure: Number of Emergency room visits
time frame: 4 weeks
description: 30-day emergency room visits rate
measure: Meters achieved in the six-minute walk test
time frame: 4 weeks
description: Aerobic capacity
measure: Yale Physical Activity Survey (YPAS)
time frame: 4 weeks
description: Physical activity assessed by the YPAS (Range 0-100) Higher values represent better
measure: Health status assessed by 36-Item Short Form Survey (SF-36)
time frame: 4 weeks
description: Health status related quality of life (Range 0-100) Higher values represent better
measure: Psychological status assessed by the The Hospital Anxiety And Depression Scale (HAD)
time frame: 4 weeks
description: Psychological status (Range 0-21) Higher values represent worst
arm group label: Prehabilitation + standard care
arm group type: Active Comparator
description: Trimodal Prehabilitation consisting on motivation, personalisation and supervision of physical activity before major surgery
arm group label: Standard care
arm group type: No Intervention
description: Standard care before major surgery
intervention type: Other
intervention name: Trimodal Prehabilitation
description: 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.
arm group label: Prehabilitation + standard care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Josep Roca, MD
role: Principal Investigator
affiliation: Hospital Clinic
facility: 
country: Spain
citation: 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
responsible party type: Principal Investigator
investigator affiliation: Hospital Clinic of Barcelona
investigator full name: Josep Roca
investigator title: Clinical Professor
mesh term: Chronic Disease
sharing ipd: No