<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/NCT03291795</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00076925</org_study_id>
    <secondary_id>P30AG028716</secondary_id>
    <nct_id>NCT03291795</nct_id>
  </id_info>
  <brief_title>Prehabilitation Exercise Plus Perioperative Optimization of Senior Health</brief_title>
  <official_title>Prehabilitation Exercise Plus Perioperative Optimization of Senior Health</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke 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>
      The purpose of this study is the examine the feasibility of and estimate the efficacy of a&#xD;
      preoperative exercise (i.e. prehabilitation) program in 40 up to sedentary older adults (i.e.&#xD;
      age 60 and over) undergoing abdominal, urologic or gynecologic surgery under the Enhanced&#xD;
      Recovery After Surgery (ERAS) protocol at Duke, using a variety of techniques to measure the&#xD;
      possible effect of this intervention. Study patients will undergo a program of&#xD;
      prehabilitation exercise for 6 days per week prescribed for them by an exercise physiologist,&#xD;
      for up to 4 weeks prior to surgery. Study participants will undergo four types of&#xD;
      assessments: Functional/Cognitive testing; Blood/cerebrospinal fluid (CSF) samples and Muscle&#xD;
      biopsies; Brain Imaging; and Brain Activity Recording. Clinical Outcomes will also be&#xD;
      obtained from the Duke electronic medical record system. The risks of the exercise&#xD;
      intervention are generally mild, since moderate exercise in this patient population generally&#xD;
      results in improved health outcomes. Data from these patients will be analyzed in comparison&#xD;
      to propensity matched patients from the Duke Markers of Alzheimer's Disease and&#xD;
      neurocognitive Outcomes after Perioperative Care (MADCO-PC) study who did not undergo this&#xD;
      prehabilitation exercise intervention. Taken together, the results of this study will allow&#xD;
      the investigators to estimate the possible effect of prehabilitation exercise on multiple&#xD;
      domains of postoperative recovery (cognition, brain connectivity, biomarkers, brain activity,&#xD;
      etc) and will provide important preliminary data.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is the examine the feasibility of and estimate the efficacy of a&#xD;
      preoperative exercise (i.e. prehabilitation) program in 40 up to sedentary older adults (i.e.&#xD;
      age 60 and over) undergoing abdominal, urologic or gynecologic surgery under the Enhanced&#xD;
      Recovery After Surgery (ERAS) protocol at Duke, using a variety of techniques to measure the&#xD;
      possible effect of this intervention. Study patients will undergo a program of&#xD;
      prehabilitation exercise for 6 days per week prescribed for them by an exercise physiologist,&#xD;
      for up to 4 weeks prior to surgery. Study participants will undergo four types of&#xD;
      assessments: Functional/Cognitive testing; Blood/CSF samples and Muscle biopsies; Brain&#xD;
      Imaging; and Brain Activity Recording. Clinical Outcomes will also be obtained from the Duke&#xD;
      electronic medical record system. The risks of the exercise intervention are generally mild,&#xD;
      since moderate exercise in this patient population generally results in improved health&#xD;
      outcomes. Data from these patients will be analyzed in comparison to propensity matched&#xD;
      patients from the Duke Markers of Alzheimer's Disease and neurocognitive Outcomes after&#xD;
      Perioperative Care (MADCO-PC) study who did not undergo this prehabilitation exercise&#xD;
      intervention. Taken together, the results of this study will allow the investigators to&#xD;
      estimate the possible effect of prehabilitation exercise on multiple domains of postoperative&#xD;
      recovery (cognition, brain connectivity, biomarkers, brain activity, etc) and will provide&#xD;
      important preliminary data and will help design future more definitive studies to test these&#xD;
      hypotheses.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    feasibility challenges&#xD;
  </why_stopped>
  <start_date type="Actual">August 20, 2017</start_date>
  <completion_date type="Actual">January 8, 2018</completion_date>
  <primary_completion_date type="Actual">January 8, 2018</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of Preoperative exercise program</measure>
    <time_frame>approximately 18 months</time_frame>
    <description>The number of patients contacted versus the number of patients enrolled will be tracked to determine recruitment feasibility. Reasons for refusal will be assessed.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Cognitive Decline</condition>
  <condition>Age-Related Memory Disorders</condition>
  <condition>Postoperative Complications</condition>
  <condition>Age-Related Atrophy</condition>
  <condition>Postoperative Cognitive Dysfunction</condition>
  <arm_group>
    <arm_group_label>Exercise Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise Intervention</intervention_name>
    <description>Study patients will undergo a program of prehabilitation exercise for 6 days per week prescribed for them by an exercise physiologist, for up to 4 weeks prior to surgery.</description>
    <arm_group_label>Exercise Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 60 and above&#xD;
&#xD;
          -  Able to speak English.&#xD;
&#xD;
          -  seen, scheduled to be seen, or eligible to be seen in Preoperative Optimization of&#xD;
             Senior Health (POSH) clinic prior to surgery&#xD;
&#xD;
          -  scheduled for general, gynecologic or urologic surgery under the Enhanced Recovery&#xD;
             After Surgery (ERAS) protocol, or eligible for ERAS protocol&#xD;
&#xD;
          -  Lives within a ~1 hr drive of Duke&#xD;
&#xD;
          -  Sedentary (not currently following physical activity guidelines)&#xD;
&#xD;
          -  Ambulatory (assistive devices ok)&#xD;
&#xD;
          -  Able to give informed consent&#xD;
&#xD;
          -  Willing to perform prescribed exercises&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inmate of a correctional facility (i.e. prisoners).&#xD;
&#xD;
          -  Documented or suspected family or personal history of malignant hyperthermia.&#xD;
&#xD;
          -  Allergy or other contraindication to receiving isoflurane&#xD;
&#xD;
          -  Receiving systemic chemotherapy after the first cognitive testing session and before&#xD;
             the 6 wk follow up cognitive testing sessions.&#xD;
&#xD;
          -  Major head trauma that occurs after the first cognitive testing session and before the&#xD;
             6 wk follow up cognitive testing sessions.&#xD;
&#xD;
          -  Anginal symptoms, known coronary artery disease (CAD), or high cardiovascular risk per&#xD;
             American College of Cardiology (ACC)/ American Heart Association (AHA) guidelines&#xD;
&#xD;
          -  Taking anticoagulants that would preclude lumbar puncture per the American Society of&#xD;
             Regional Anesthesia guidelines.&#xD;
&#xD;
          -  Diagnosed history of dementia.&#xD;
&#xD;
          -  Inability to ambulate independently.&#xD;
&#xD;
          -  Otherwise not appropriate for study participation in the judgement of the Principal&#xD;
             Investigator, such as (but not limited to) because the patient does not have the&#xD;
             cardiopulmonary capacity to complete the exercise regimen.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Miles Berger, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>July 1, 2019</last_update_submitted>
  <last_update_submitted_qc>July 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Memory Disorders</mesh_term>
    <mesh_term>Postoperative Complications</mesh_term>
    <mesh_term>Postoperative Cognitive Complications</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03291795
org study id: Pro00076925
secondary id: P30AG028716
nct id: NCT03291795
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is the examine the feasibility of and estimate the efficacy of a
      preoperative exercise (i.e. prehabilitation) program in 40 up to sedentary older adults (i.e.
      age 60 and over) undergoing abdominal, urologic or gynecologic surgery under the Enhanced
      Recovery After Surgery (ERAS) protocol at Duke, using a variety of techniques to measure the
      possible effect of this intervention. Study patients will undergo a program of
      prehabilitation exercise for 6 days per week prescribed for them by an exercise physiologist,
      for up to 4 weeks prior to surgery. Study participants will undergo four types of
      assessments: Functional/Cognitive testing; Blood/cerebrospinal fluid (CSF) samples and Muscle
      biopsies; Brain Imaging; and Brain Activity Recording. Clinical Outcomes will also be
      obtained from the Duke electronic medical record system. The risks of the exercise
      intervention are generally mild, since moderate exercise in this patient population generally
      results in improved health outcomes. Data from these patients will be analyzed in comparison
      to propensity matched patients from the Duke Markers of Alzheimer's Disease and
      neurocognitive Outcomes after Perioperative Care (MADCO-PC) study who did not undergo this
      prehabilitation exercise intervention. Taken together, the results of this study will allow
      the investigators to estimate the possible effect of prehabilitation exercise on multiple
      domains of postoperative recovery (cognition, brain connectivity, biomarkers, brain activity,
      etc) and will provide important preliminary data.
The purpose of this study is the examine the feasibility of and estimate the efficacy of a
      preoperative exercise (i.e. prehabilitation) program in 40 up to sedentary older adults (i.e.
      age 60 and over) undergoing abdominal, urologic or gynecologic surgery under the Enhanced
      Recovery After Surgery (ERAS) protocol at Duke, using a variety of techniques to measure the
      possible effect of this intervention. Study patients will undergo a program of
      prehabilitation exercise for 6 days per week prescribed for them by an exercise physiologist,
      for up to 4 weeks prior to surgery. Study participants will undergo four types of
      assessments: Functional/Cognitive testing; Blood/CSF samples and Muscle biopsies; Brain
      Imaging; and Brain Activity Recording. Clinical Outcomes will also be obtained from the Duke
      electronic medical record system. The risks of the exercise intervention are generally mild,
      since moderate exercise in this patient population generally results in improved health
      outcomes. Data from these patients will be analyzed in comparison to propensity matched
      patients from the Duke Markers of Alzheimer's Disease and neurocognitive Outcomes after
      Perioperative Care (MADCO-PC) study who did not undergo this prehabilitation exercise
      intervention. Taken together, the results of this study will allow the investigators to
      estimate the possible effect of prehabilitation exercise on multiple domains of postoperative
      recovery (cognition, brain connectivity, biomarkers, brain activity, etc) and will provide
      important preliminary data and will help design future more definitive studies to test these
      hypotheses.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Feasibility of Preoperative exercise program
time frame: approximately 18 months
description: The number of patients contacted versus the number of patients enrolled will be tracked to determine recruitment feasibility. Reasons for refusal will be assessed.
arm group label: Exercise Intervention
arm group type: Experimental
intervention type: Other
intervention name: Exercise Intervention
description: Study patients will undergo a program of prehabilitation exercise for 6 days per week prescribed for them by an exercise physiologist, for up to 4 weeks prior to surgery.
arm group label: Exercise Intervention
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Miles Berger, MD, PhD
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Memory Disorders
mesh term: Postoperative Complications
mesh term: Postoperative Cognitive Complications
mesh term: Cognitive Dysfunction
sharing ipd: Undecided