<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/NCT04485611</url>
  </required_header>
  <id_info>
    <org_study_id>F3468-P</org_study_id>
    <secondary_id>728745</secondary_id>
    <nct_id>NCT04485611</nct_id>
  </id_info>
  <brief_title>Prehabilitation of Venterans With Exercise and Nutrition</brief_title>
  <acronym>PREVENT</acronym>
  <official_title>Prehabilitation of Veterans With Exercise and Nutrition (PREVENT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>VA Office of Research and Development</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of VA's RR&amp;D office is to maximize functional recovery. This proposal will allow the&#xD;
      investigators to test an intervention that combines the fundamentals of Physical Medicine and&#xD;
      Rehabilitation with state-of-the-art nutritional support and innovations in care such as&#xD;
      telehealth and the use of activity trackers to optimize patients before high-risk surgery.&#xD;
      This intervention has the potential to not only reduce complications and hospital&#xD;
      readmissions, but also to maximize functional recovery and quality of life for thousands of&#xD;
      Veterans undergoing high-risk surgery every year. Furthermore, the proposal is the first step&#xD;
      in the design and implementation of prehabilitative services for Veterans living in rural&#xD;
      areas and those with inadequate support or transportation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Approximately half a million operations are performed each year in VA hospitals across the&#xD;
      country. Veterans undergoing high-risk surgery have a 1 in 5 chance of suffering&#xD;
      complications, a 1 in 10 chance of being readmitted to the hospital within 30 days, and a 1&#xD;
      in 50 chance of dying within 30 days. Long-term survival is significantly reduced for those&#xD;
      patients who have perioperative complications, even if they survive to leave the hospital.&#xD;
&#xD;
      Low fitness and poor functional status are among the strongest predictors of postsurgical&#xD;
      complications. Prehabilitation takes advantage of the weeks leading up to surgery in order to&#xD;
      improve fitness, mobility and nutrition in preparation for the upcoming surgical stress.&#xD;
      Indeed, prehabilitation has been shown to improve fitness and reduce complications and&#xD;
      quality of life in high-risk surgical patients. The most effective prehabilitation programs&#xD;
      combine exercise plus nutritional support (are multimodal), and provide exercise that is&#xD;
      supervised and individualized, ensuring the appropriate exercise intensity and increasing it&#xD;
      gradually according to improvements in fitness and strength. Most supervised prehabilitation&#xD;
      programs are facility-based, but travel time, distance, and transportation limit&#xD;
      participation. Unfortunately, home-based prehabilitation programs have shown small effect&#xD;
      sizes and low compliance rates, likely because adequate training intensity is required in&#xD;
      programs of such short duration, which is often not achieved with unsupervised home-based&#xD;
      programs. A prehabilitation program that is delivered using telehealth would be ideal,&#xD;
      because it combines accessibility with supervision, encouraging compliance and ensuring&#xD;
      adequate training intensity, but such programs do not currently exit within the VA.&#xD;
&#xD;
      The investigators aim to determine the feasibility, acceptability, safety, and effect size&#xD;
      estimates for outcomes of interest of a short-term (3-4 week) multimodal prehabilitation&#xD;
      intervention that is supervised and individualized, yet is delivered at home using telehealth&#xD;
      technology. The exercise program will consist of 3 days of supervised telehealth exercise&#xD;
      sessions per week consisting of moderate intensity aerobic training and resistive and&#xD;
      functional training. Nutritional support will consist of tailored nutritional advice, whey&#xD;
      protein supplementation and multivitamin and vitamin D supplementation during prehabilitation&#xD;
      and following hospital discharge for 6 weeks. Compliance with the interventions will be&#xD;
      enhanced by daily automated text messages using the VA Annie App. In addition, participants&#xD;
      will be contacted weekly in order to identify problems with compliance and to provide&#xD;
      counseling. Post-operative exercise sessions will resume as early as 1 week postoperatively&#xD;
      and progressed as allowed according to the type of surgery. Text messages and weekly calls&#xD;
      will also resume postoperatively until the 6-week follow-up visit to encourage progressive&#xD;
      increases in unsupervised physical activity and nutritional support. Objective physical&#xD;
      activity data will be collected using physical activity trackers, which patients will wear&#xD;
      from the time of enrollment until the 6-week postoperative follow-up visit. Follow-up will&#xD;
      continue for a total of 6 months postoperatively.&#xD;
&#xD;
      The main outcomes of interest include feasibility (acceptance rates), acceptability&#xD;
      (compliance rates), and safety (number of adverse events). The investigators will also&#xD;
      measure changes in fitness, nutritional state, anxiety and depression, and health-related&#xD;
      quality of life throughout the study period in order to estimate effect sizes, which will&#xD;
      inform a future randomized trial. The proposed work combines several innovations in the&#xD;
      delivery of exercise and nutrition and applies them to the perioperative high-risk population&#xD;
      for the first time. It constitutes the first step toward the study of a multimodal&#xD;
      &quot;tele-prehabilitation&quot; program on postoperative and long-term outcomes following high-risk&#xD;
      surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 27, 2021</start_date>
  <completion_date type="Anticipated">September 29, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 2, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>The intervention will consist of a period of supervised multimodal prehabilitation prior to high-risk surgery (aerobic and resistance training sessions 3 times/week plus nutritional support) delivered using telehealth technology, and similar sessions resuming after surgery and for up to 6 weeks (rehabilitation).</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility, measured as acceptance rate</measure>
    <time_frame>24 weeks</time_frame>
    <description>Acceptance rate will be calculated as the number of enrolled divided by the number of eligible patients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability, measured as compliance rate</measure>
    <time_frame>24 weeks</time_frame>
    <description>For the exercise intervention, we will measure the percentage of patients completing 75% of sessions divided by the number of enrolled patients. For the nutritional intervention, compliance will be measured by the percentage of patients with 75% adherence to protein intake goal, as assessed using the text message-based nutrition diary, lids returned, and 24-hour recall administered during the weekly telephone call.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety, measured as the number of adverse events during exercise.</measure>
    <time_frame>12 weeks</time_frame>
    <description>A significant injury or medical event is defined as an event that causes the participant to seek attention from a health professional or limits their activities of daily living for at least two days.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reasons for enrollment/non-enrollment</measure>
    <time_frame>24 weeks</time_frame>
    <description>We will evaluate reasons for enrollment/non-enrollment in the program using patient interviews and semi-structured questionnaires.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physical function - Aerobic endurance</measure>
    <time_frame>6 months</time_frame>
    <description>Aerobic endurance will be assessed using the 2-minute step test (2MST). The 2MST requires that tested individuals march in place as fast as possible for 2 minutes while lifting the knees to a height midway between their patella and iliac crest when standing (typically marked on the wall using tape). Scoring involves counting the number of times the right knee reaches the tape level in two minutes and comparing against normative values for age. A higher number denotes better aerobic endurance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>6 months</time_frame>
    <description>Pre to post intervention changes in QOL as measured by the SF-36 questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety and Depression</measure>
    <time_frame>6 months</time_frame>
    <description>Pre to post intervention changes in anxiety and depression as measured by the Hospital Anxiety &amp; Depression Scale (HADS) questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical function - Lower extremity strength and balance</measure>
    <time_frame>3 months</time_frame>
    <description>Lower extremity strength and balance will be assessed using the 5-repetition sit-to-stand test (5XSST). The 5XSST assesses functional lower extremity strength, transitional movements, balance, and fall risk in older adults. The 5XSST scoring is based on the amount of time (to the nearest decimal in seconds) a patient is able to transfer from a seated to a standing position and back to sitting five times. The lower the time to complete the test the better the outcome of the test. The age matched norms score are 11.4 seconds for 60-69 years age groups and 12.6 seconds and 14.8 seconds for 70-79 and 80-89 years of age group ,respectively.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Frailty</condition>
  <arm_group>
    <arm_group_label>Prehabilitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This pilot cohort will undergo an intervention and will be followed for up to 6 months. The study does not include a comparator group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Supervised aerobic + resistance training and nutritional support</intervention_name>
    <description>The intervention will consist of individualized exercise training delivered remotely using VA telehealth technology, combined with nutritional support consisting of tailored nutritional advice, protein supplementation, multivitamin and vitamin D supplements]]. Adherence to the intervention will be enhanced by use of automated text messages and monitored using activity trackers.</description>
    <arm_group_label>Prehabilitation</arm_group_label>
    <other_name>Multimodal prehabilitation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Scheduled for high-risk surgery&#xD;
&#xD;
          -  Time from assessment to surgery 21 days&#xD;
&#xD;
          -  Age 50 years&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  5RSTS time &gt;11 sec and/or TMST score 25% percentile for gender/age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A score of &lt;21 (high school) or &lt;20 (less than high school) on the Montreal Cognitive&#xD;
             Assessment (MoCA)&#xD;
&#xD;
          -  Dementia diagnosis&#xD;
&#xD;
          -  Inability to complete physical function assessment&#xD;
&#xD;
          -  ASA categories 4 and 5&#xD;
&#xD;
          -  Living in skilled nursing facility&#xD;
&#xD;
          -  No access to a telephone&#xD;
&#xD;
          -  Advanced chronic kidney disease (KDIGO stage 4 and 5)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Atilio Barbeito, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Durham VA Medical Center, Durham, NC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Amanda E Wood, PhD</last_name>
    <phone>(253) 583-1652</phone>
    <email>Amanda.Wood@va.gov</email>
  </overall_contact>
  <location>
    <facility>
      <name>Durham VA Medical Center, Durham, NC</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705-3875</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Atilio Barbeito, MD</last_name>
      <email>Atilio.Barbeito@va.gov</email>
    </contact>
    <contact_backup>
      <last_name>Virginia J Rhodes</last_name>
      <phone>(919) 286-0411</phone>
      <phone_ext>177632</phone_ext>
      <email>Virginia.Rhodes@va.gov</email>
    </contact_backup>
    <investigator>
      <last_name>Atilio Barbeito, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>August 17, 2023</last_update_submitted>
  <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>frailty</keyword>
  <keyword>exercise training</keyword>
  <keyword>telemedicine</keyword>
  <keyword>nutritional support</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Frailty</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/NCT04485611
org study id: F3468-P
secondary id: 728745
nct id: NCT04485611
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The goal of VA's RR&D office is to maximize functional recovery. This proposal will allow the
      investigators to test an intervention that combines the fundamentals of Physical Medicine and
      Rehabilitation with state-of-the-art nutritional support and innovations in care such as
      telehealth and the use of activity trackers to optimize patients before high-risk surgery.
      This intervention has the potential to not only reduce complications and hospital
      readmissions, but also to maximize functional recovery and quality of life for thousands of
      Veterans undergoing high-risk surgery every year. Furthermore, the proposal is the first step
      in the design and implementation of prehabilitative services for Veterans living in rural
      areas and those with inadequate support or transportation.
Approximately half a million operations are performed each year in VA hospitals across the
      country. Veterans undergoing high-risk surgery have a 1 in 5 chance of suffering
      complications, a 1 in 10 chance of being readmitted to the hospital within 30 days, and a 1
      in 50 chance of dying within 30 days. Long-term survival is significantly reduced for those
      patients who have perioperative complications, even if they survive to leave the hospital.

      Low fitness and poor functional status are among the strongest predictors of postsurgical
      complications. Prehabilitation takes advantage of the weeks leading up to surgery in order to
      improve fitness, mobility and nutrition in preparation for the upcoming surgical stress.
      Indeed, prehabilitation has been shown to improve fitness and reduce complications and
      quality of life in high-risk surgical patients. The most effective prehabilitation programs
      combine exercise plus nutritional support (are multimodal), and provide exercise that is
      supervised and individualized, ensuring the appropriate exercise intensity and increasing it
      gradually according to improvements in fitness and strength. Most supervised prehabilitation
      programs are facility-based, but travel time, distance, and transportation limit
      participation. Unfortunately, home-based prehabilitation programs have shown small effect
      sizes and low compliance rates, likely because adequate training intensity is required in
      programs of such short duration, which is often not achieved with unsupervised home-based
      programs. A prehabilitation program that is delivered using telehealth would be ideal,
      because it combines accessibility with supervision, encouraging compliance and ensuring
      adequate training intensity, but such programs do not currently exit within the VA.

      The investigators aim to determine the feasibility, acceptability, safety, and effect size
      estimates for outcomes of interest of a short-term (3-4 week) multimodal prehabilitation
      intervention that is supervised and individualized, yet is delivered at home using telehealth
      technology. The exercise program will consist of 3 days of supervised telehealth exercise
      sessions per week consisting of moderate intensity aerobic training and resistive and
      functional training. Nutritional support will consist of tailored nutritional advice, whey
      protein supplementation and multivitamin and vitamin D supplementation during prehabilitation
      and following hospital discharge for 6 weeks. Compliance with the interventions will be
      enhanced by daily automated text messages using the VA Annie App. In addition, participants
      will be contacted weekly in order to identify problems with compliance and to provide
      counseling. Post-operative exercise sessions will resume as early as 1 week postoperatively
      and progressed as allowed according to the type of surgery. Text messages and weekly calls
      will also resume postoperatively until the 6-week follow-up visit to encourage progressive
      increases in unsupervised physical activity and nutritional support. Objective physical
      activity data will be collected using physical activity trackers, which patients will wear
      from the time of enrollment until the 6-week postoperative follow-up visit. Follow-up will
      continue for a total of 6 months postoperatively.

      The main outcomes of interest include feasibility (acceptance rates), acceptability
      (compliance rates), and safety (number of adverse events). The investigators will also
      measure changes in fitness, nutritional state, anxiety and depression, and health-related
      quality of life throughout the study period in order to estimate effect sizes, which will
      inform a future randomized trial. The proposed work combines several innovations in the
      delivery of exercise and nutrition and applies them to the perioperative high-risk population
      for the first time. It constitutes the first step toward the study of a multimodal
      "tele-prehabilitation" program on postoperative and long-term outcomes following high-risk
      surgery.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: The intervention will consist of a period of supervised multimodal prehabilitation prior to high-risk surgery (aerobic and resistance training sessions 3 times/week plus nutritional support) delivered using telehealth technology, and similar sessions resuming after surgery and for up to 6 weeks (rehabilitation).
primary purpose: Prevention
masking: None (Open Label)
measure: Feasibility, measured as acceptance rate
time frame: 24 weeks
description: Acceptance rate will be calculated as the number of enrolled divided by the number of eligible patients.
measure: Acceptability, measured as compliance rate
time frame: 24 weeks
description: For the exercise intervention, we will measure the percentage of patients completing 75% of sessions divided by the number of enrolled patients. For the nutritional intervention, compliance will be measured by the percentage of patients with 75% adherence to protein intake goal, as assessed using the text message-based nutrition diary, lids returned, and 24-hour recall administered during the weekly telephone call.
measure: Safety, measured as the number of adverse events during exercise.
time frame: 12 weeks
description: A significant injury or medical event is defined as an event that causes the participant to seek attention from a health professional or limits their activities of daily living for at least two days.
measure: Reasons for enrollment/non-enrollment
time frame: 24 weeks
description: We will evaluate reasons for enrollment/non-enrollment in the program using patient interviews and semi-structured questionnaires.
measure: Physical function - Aerobic endurance
time frame: 6 months
description: Aerobic endurance will be assessed using the 2-minute step test (2MST). The 2MST requires that tested individuals march in place as fast as possible for 2 minutes while lifting the knees to a height midway between their patella and iliac crest when standing (typically marked on the wall using tape). Scoring involves counting the number of times the right knee reaches the tape level in two minutes and comparing against normative values for age. A higher number denotes better aerobic endurance.
measure: Quality of Life
time frame: 6 months
description: Pre to post intervention changes in QOL as measured by the SF-36 questionnaire
measure: Anxiety and Depression
time frame: 6 months
description: Pre to post intervention changes in anxiety and depression as measured by the Hospital Anxiety & Depression Scale (HADS) questionnaire
measure: Physical function - Lower extremity strength and balance
time frame: 3 months
description: Lower extremity strength and balance will be assessed using the 5-repetition sit-to-stand test (5XSST). The 5XSST assesses functional lower extremity strength, transitional movements, balance, and fall risk in older adults. The 5XSST scoring is based on the amount of time (to the nearest decimal in seconds) a patient is able to transfer from a seated to a standing position and back to sitting five times. The lower the time to complete the test the better the outcome of the test. The age matched norms score are 11.4 seconds for 60-69 years age groups and 12.6 seconds and 14.8 seconds for 70-79 and 80-89 years of age group ,respectively.
arm group label: Prehabilitation
arm group type: Experimental
description: This pilot cohort will undergo an intervention and will be followed for up to 6 months. The study does not include a comparator group.
intervention type: Behavioral
intervention name: Supervised aerobic + resistance training and nutritional support
description: The intervention will consist of individualized exercise training delivered remotely using VA telehealth technology, combined with nutritional support consisting of tailored nutritional advice, protein supplementation, multivitamin and vitamin D supplements]]. Adherence to the intervention will be enhanced by use of automated text messages and monitored using activity trackers.
arm group label: Prehabilitation
other name: Multimodal prehabilitation
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Atilio Barbeito, MD
role: Principal Investigator
affiliation: Durham VA Medical Center, Durham, NC
last name: Amanda E Wood, PhD
phone: (253) 583-1652
email: Amanda.Wood@va.gov
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Frailty
sharing ipd: No