<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/NCT04504266</url>
  </required_header>
  <id_info>
    <org_study_id>51827</org_study_id>
    <nct_id>NCT04504266</nct_id>
  </id_info>
  <brief_title>Perioperative Optimization With Enhanced Recovery</brief_title>
  <acronym>POWER</acronym>
  <official_title>Perioperative Optimization With Enhanced Recovery: The Effect of Health Habits on Surgical Outcomes in Patients Undergoing Major Abdominal Operations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>No</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>
      This is a randomized controlled trial examining the effect of a motivational interview and&#xD;
      perioperative mobile-app based nutrition and exercise intervention on surgical outcomes. The&#xD;
      hypothesis is that such an intervention will improve surgical outcomes. Patients who are&#xD;
      planned to undergo major elective abdominal surgery will be randomized to standard care or&#xD;
      the nutrition/exercise intervention. This intervention consists of a mobile-app based&#xD;
      coaching program to encourage patients to exercise and adopt a Mediterranean diet in the 3+&#xD;
      weeks prior to surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">August 14, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Surgical Complications occurring in the 90 day post-operative period, measured by the comprehensive complication index</measure>
    <time_frame>90 days after surgery</time_frame>
    <description>The comprehensive complication index is an integrated score from 0 to 100 of all complications occurring in a specified time period and their severities as categorized by Clavien-Dindo classification. Calculation of the CCI is via a web-based calculator (www.assessurgery.com).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in 6 minute walk test</measure>
    <time_frame>It will take about 6 minutes to assess, and this will be performed at enrollment, right before surgery, and at 30 and 90 days after surgery</time_frame>
    <description>Participants will be asked to walk as fast they can for 6 minutes using a validated mobile application (Timed Walk) to measure the distance walked.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">368</enrollment>
  <condition>Complication of Surgical Procedure</condition>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Recommendations to follow Mediterranean diet and exercise regularly before surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prehab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This intervention consists of a motivational interview and a mobile-app based coaching program to encourage patients to exercise and adopt a Mediterranean diet in the 3+ weeks prior to surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>POWER</intervention_name>
    <description>This intervention consists of a motivational interview and a mobile-app based coaching program to encourage patients to exercise and adopt a Mediterranean diet in the 3+ weeks prior to surgery.</description>
    <arm_group_label>Prehab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  major abdominal surgery in 3+ weeks&#xD;
&#xD;
          -  English or Spanish speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to use smartphone&#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>Cindy Kin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Brendan Visser, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford Health Care</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>August 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>April 7, 2022</last_update_submitted>
  <last_update_submitted_qc>April 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Cindy Kin</investigator_full_name>
    <investigator_title>Assistant Professor of Surgery</investigator_title>
  </responsible_party>
  <keyword>prehabilitation, exercise, nutrition</keyword>
  <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/NCT04504266
org study id: 51827
nct id: NCT04504266
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a randomized controlled trial examining the effect of a motivational interview and
      perioperative mobile-app based nutrition and exercise intervention on surgical outcomes. The
      hypothesis is that such an intervention will improve surgical outcomes. Patients who are
      planned to undergo major elective abdominal surgery will be randomized to standard care or
      the nutrition/exercise intervention. This intervention consists of a mobile-app based
      coaching program to encourage patients to exercise and adopt a Mediterranean diet in the 3+
      weeks prior to surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Surgical Complications occurring in the 90 day post-operative period, measured by the comprehensive complication index
time frame: 90 days after surgery
description: The comprehensive complication index is an integrated score from 0 to 100 of all complications occurring in a specified time period and their severities as categorized by Clavien-Dindo classification. Calculation of the CCI is via a web-based calculator (www.assessurgery.com).
measure: Change in 6 minute walk test
time frame: It will take about 6 minutes to assess, and this will be performed at enrollment, right before surgery, and at 30 and 90 days after surgery
description: Participants will be asked to walk as fast they can for 6 minutes using a validated mobile application (Timed Walk) to measure the distance walked.
arm group label: Control Arm
arm group type: No Intervention
description: Recommendations to follow Mediterranean diet and exercise regularly before surgery.
arm group label: Prehab
arm group type: Experimental
description: This intervention consists of a motivational interview and a mobile-app based coaching program to encourage patients to exercise and adopt a Mediterranean diet in the 3+ weeks prior to surgery.
intervention type: Behavioral
intervention name: POWER
description: This intervention consists of a motivational interview and a mobile-app based coaching program to encourage patients to exercise and adopt a Mediterranean diet in the 3+ weeks prior to surgery.
arm group label: Prehab
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Cindy Kin, MD
role: Principal Investigator
affiliation: Stanford University
last name: Brendan Visser, MD
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Cindy Kin
investigator title: Assistant Professor of Surgery
sharing ipd: No