xml: <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/NCT05977556</url>
    </required_header>
    <id_info>
      <org_study_id>Pro00122843</org_study_id>
      <nct_id>NCT05977556</nct_id>
    </id_info>
    <brief_title>Perioperative Prehabilitation on Markers of Fitness and Frailty in Patients Undergoing Elective Surgery</brief_title>
    <official_title>The Effect of Perioperative Prehabilitation on Markers of Fitness and Frailty in Patients Undergoing Elective Surgery: a Pilot, Pragmatic, Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Victor Ezeugwu</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Royal Alexandra Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Alberta</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>
        A growing body of evidence suggests that patients who receive good perioperative care (i.e.&#xD;
        care prior to surgery, during surgery, and after surgery) tend to have fewer complications,&#xD;
        quicker recovery times, and shorter hospital stays. A key component of good perioperative&#xD;
        care is recognizing individuals who have diminished physiological reserves (i.e. those who&#xD;
        are vulnerable or frail). The stress of an invasive procedure can exhaust the diminished&#xD;
        reserves of patients who are frail, which can in turn lead to perioperative complications,&#xD;
        mortality and an increase burden to the healthcare system.&#xD;
  &#xD;
        Early interventions in patients with diminished reserves can be applied to reduce the risk of&#xD;
        complications and poor outcomes. There are emerging studies that show promising benefits of&#xD;
        perioperative interventions, such as prehabilitation, though with some mixed findings.&#xD;
        Exercise has been shown to reverse or modify the molecular driving factors of frailty, which&#xD;
        involve dysregulation of cytokine and endocrine pathways.&#xD;
  &#xD;
        Physical inactivity and prolonged sedentary behaviors are also emerging concerns in frailty&#xD;
        because of the implicated deleterious health effects. Sedentary behaviors are associated with&#xD;
        prevalence and severity of frailty. Among pre-frail and frail inactive adults, sedentary time&#xD;
        is associated with higher mortality. Increasing physical activity is recommended as the most&#xD;
        feasible approach to prevent and treat frailty. The aim of this study is to determine if a&#xD;
        prehabilitation intervention that combines neuromuscular strength training and intervention&#xD;
        to reduce sedentary behavior reduces complications, length of stay, and patient recovery,&#xD;
        thereby also reducing the burden on the healthcare system.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Frailty is a complex syndrome associated with poor health outcomes in adults, independent of&#xD;
        chronological age. Early identification and management of frailty can help improve outcomes&#xD;
        and quality of life. Physical activity and exercise interventions, including strength&#xD;
        training, have been recommended to manage frailty. Prehabilitation, a preventive intervention&#xD;
        before a process of care, has shown promise but with mixed findings.&#xD;
        Weight/resistance/strength training and reducing sedentary behavior are important components&#xD;
        in frailty management. Sedentary behavior is associated with higher mortality in frail&#xD;
        adults. Increasing physical activity may be helpful in preventing and treating frailty. We&#xD;
        aim to test a prehabilitation program combining neuromuscular exercise and sedentary behavior&#xD;
        intervention in frail adults undergoing elective surgery.&#xD;
  &#xD;
        Objective: To evaluate the effect of a 12-week prehabilitation program that combines muscular&#xD;
        strengthening exercise with reducing sedentary behaviour for patients 50 years of age or&#xD;
        older with frailty undergoing elective surgery.&#xD;
  &#xD;
        Hypothesis: The main hypothesis is that the combined prehabilitation program will improve&#xD;
        postoperative recovery and reduce the risk of adverse outcomes following elective surgery by&#xD;
        improving frailty levels.&#xD;
  &#xD;
        Methods: Fifty adults who are vulnerable, mildly, or moderately frail score of 4-6 on the&#xD;
        Clinical Frailty Scale (CFS) will be randomly assigned to either the experimental (n=25) or&#xD;
        control (n=25) group. The experimental group will receive up to 24 sessions of neuromuscular&#xD;
        strength training delivered twice a week over a 12-week period combined with an intervention&#xD;
        to reduce and frequently interrupt sedentary behavior. The control group will receive&#xD;
        standard of care that is provided as part of the perioperative surgical procedure and&#xD;
        subsequent rehabilitation. The &quot;usual care&quot; comparator arm appears to be an appropriate&#xD;
        option for a pilot pragmatic study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">March 2025</completion_date>
    <primary_completion_date type="Anticipated">March 2025</primary_completion_date>
    <phase>Phase 1</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>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change from baseline gait speed at 12 and 24 weeks</measure>
      <time_frame>12 and 24 weeks</time_frame>
      <description>Comfortable walking speed will be assessed over a 5-meter walkway</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change from baseline physical activity at 12 and 24 weeks</measure>
      <time_frame>12 and 24 weeks</time_frame>
      <description>Activpal-derived time spent per day in physical activity</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline sedentary behavior at 12 and 24 weeks</measure>
      <time_frame>12 and 24 weeks</time_frame>
      <description>Activpal-derived time spent per day in sedentary behavior</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline sleep at 12 and 24 weeks</measure>
      <time_frame>12 and 24 weeks</time_frame>
      <description>Activpal-derived time spent per day in sleep</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline Timed-Up and Go (TUG) test at 12 and 24 weeks</measure>
      <time_frame>12 and 24 weeks</time_frame>
      <description>Functional mobility will be assessed using the TUG test</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline functional lower extremity strength at 12 and 24 weeks</measure>
      <time_frame>12 and 24 weeks</time_frame>
      <description>Lower extremity strength will be measured using the 30 seconds sit-stand test</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline hand grip strength at 12 and 24 weeks</measure>
      <time_frame>12 and 24 weeks</time_frame>
      <description>Grip strength will be assessed using a dynamometer</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline Barthel Index at 12 and 24 weeks</measure>
      <time_frame>12 and 24 weeks</time_frame>
      <description>Level of independence in activities of daily living (ADL) will be assessed using Barthel Index</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of hospital stay after surgery to be determined at 12 and 24 weeks</measure>
      <time_frame>12 and 24 weeks</time_frame>
      <description>We will determine the length of stay in the hospital</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Readmission rate to hospital after discharge to be determined at 12 and 24 weeks</measure>
      <time_frame>12 and 24 weeks</time_frame>
      <description>We will determine the hospital readmissions rate within 30 days of discharge.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline Saint Louis University mental status (SLUMS) test</measure>
      <time_frame>12 and 24 weeks</time_frame>
      <description>Cognitive assessment will be completed using the SLUMS test</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with reported postoperative complications</measure>
      <time_frame>12 and 24 weeks</time_frame>
      <description>We will determine the number of participants with postoperative complications</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Frailty</condition>
    <arm_group>
      <arm_group_label>Experimental</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Neuromuscular strength training: The experimental group will receive up to 24 sessions of neuromuscular strength training led by a physical therapist with expertise in geriatrics and movement behaviors. The program includes exercises such as pelvic lifts, lunges, step-ups, squats, and sit-stands. The difficulty level will progressively increase using techniques like manual resistance, dumbbells, and unstable surfaces.&#xD;
  Sedentary behavior intervention: The experimental group will also undergo a sedentary behavior intervention based on social cognitive theory. It involves weekly coaching sessions to enhance self-efficacy in reducing sedentary time and increasing light-intensity activity throughout the day. Participants will be provided with a wrist-worn Fitbit activity monitor for daily feedback and to track adherence to the intervention. The aim is to encourage participants to &quot;sit less and move more&quot; throughout their waking hours.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard of care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The control group will receive standard of care that is provided as part of the perioperative surgical procedure and subsequent rehabilitation.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Combined neuromuscular exercise training and 'sit less, move more' program</intervention_name>
      <description>Neuromuscular strength training: The experimental group will receive up to 24 sessions of neuromuscular strength training led by a physical therapist with expertise in geriatrics and movement behaviors. The program includes exercises such as pelvic lifts, lunges, step-ups, squats, and sit-stands. The difficulty level will progressively increase using techniques like manual resistance, dumbbells, and unstable surfaces.&#xD;
  Sedentary behavior intervention: The experimental group will also undergo a sedentary behavior intervention based on social cognitive theory. It involves weekly coaching sessions to enhance self-efficacy in reducing sedentary time and increasing light-intensity activity throughout the day. Participants will be provided with a wrist-worn Fitbit activity monitor for daily feedback and to track adherence to the intervention. The aim is to encourage participants to &quot;sit less and move more&quot; throughout their waking hours.</description>
      <arm_group_label>Experimental</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  50 years of age or older&#xD;
  &#xD;
            -  score of 4-6 (vulnerable, mildly or moderately frail) on the clinical frailty scale&#xD;
               (CFS)&#xD;
  &#xD;
            -  scheduled for elective surgery&#xD;
  &#xD;
            -  ambulatory (indoor and/or outdoor) with or without gait aids&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Unstable medical conditions that limit exercise tolerance such as ME/CFS&#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>Naheed Rajabali, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Alberta Health services</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Victor Ezeugwu, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Alberta</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Victor E. Ezeugwu, PhD</last_name>
      <phone>7804925108</phone>
      <email>ezeugwu@ualberta.ca</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ritika Sharma</last_name>
      <email>ritika8@ualberta.ca</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Royal Alexandra Hospital</name>
        <address>
          <city>Edmonton</city>
          <country>Canada</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>University of Alberta</investigator_affiliation>
      <investigator_full_name>Victor Ezeugwu</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <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>
  
  
text: 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/NCT05977556
  org study id: Pro00122843
  nct id: NCT05977556
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  A growing body of evidence suggests that patients who receive good perioperative care (i.e.
        care prior to surgery, during surgery, and after surgery) tend to have fewer complications,
        quicker recovery times, and shorter hospital stays. A key component of good perioperative
        care is recognizing individuals who have diminished physiological reserves (i.e. those who
        are vulnerable or frail). The stress of an invasive procedure can exhaust the diminished
        reserves of patients who are frail, which can in turn lead to perioperative complications,
        mortality and an increase burden to the healthcare system.
  
        Early interventions in patients with diminished reserves can be applied to reduce the risk of
        complications and poor outcomes. There are emerging studies that show promising benefits of
        perioperative interventions, such as prehabilitation, though with some mixed findings.
        Exercise has been shown to reverse or modify the molecular driving factors of frailty, which
        involve dysregulation of cytokine and endocrine pathways.
  
        Physical inactivity and prolonged sedentary behaviors are also emerging concerns in frailty
        because of the implicated deleterious health effects. Sedentary behaviors are associated with
        prevalence and severity of frailty. Among pre-frail and frail inactive adults, sedentary time
        is associated with higher mortality. Increasing physical activity is recommended as the most
        feasible approach to prevent and treat frailty. The aim of this study is to determine if a
        prehabilitation intervention that combines neuromuscular strength training and intervention
        to reduce sedentary behavior reduces complications, length of stay, and patient recovery,
        thereby also reducing the burden on the healthcare system.
  Frailty is a complex syndrome associated with poor health outcomes in adults, independent of
        chronological age. Early identification and management of frailty can help improve outcomes
        and quality of life. Physical activity and exercise interventions, including strength
        training, have been recommended to manage frailty. Prehabilitation, a preventive intervention
        before a process of care, has shown promise but with mixed findings.
        Weight/resistance/strength training and reducing sedentary behavior are important components
        in frailty management. Sedentary behavior is associated with higher mortality in frail
        adults. Increasing physical activity may be helpful in preventing and treating frailty. We
        aim to test a prehabilitation program combining neuromuscular exercise and sedentary behavior
        intervention in frail adults undergoing elective surgery.
  
        Objective: To evaluate the effect of a 12-week prehabilitation program that combines muscular
        strengthening exercise with reducing sedentary behaviour for patients 50 years of age or
        older with frailty undergoing elective surgery.
  
        Hypothesis: The main hypothesis is that the combined prehabilitation program will improve
        postoperative recovery and reduce the risk of adverse outcomes following elective surgery by
        improving frailty levels.
  
        Methods: Fifty adults who are vulnerable, mildly, or moderately frail score of 4-6 on the
        Clinical Frailty Scale (CFS) will be randomly assigned to either the experimental (n=25) or
        control (n=25) group. The experimental group will receive up to 24 sessions of neuromuscular
        strength training delivered twice a week over a 12-week period combined with an intervention
        to reduce and frequently interrupt sedentary behavior. The control group will receive
        standard of care that is provided as part of the perioperative surgical procedure and
        subsequent rehabilitation. The "usual care" comparator arm appears to be an appropriate
        option for a pilot pragmatic study.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  measure: Change from baseline gait speed at 12 and 24 weeks
  time frame: 12 and 24 weeks
  description: Comfortable walking speed will be assessed over a 5-meter walkway
  measure: Change from baseline physical activity at 12 and 24 weeks
  time frame: 12 and 24 weeks
  description: Activpal-derived time spent per day in physical activity
  measure: Change from baseline sedentary behavior at 12 and 24 weeks
  time frame: 12 and 24 weeks
  description: Activpal-derived time spent per day in sedentary behavior
  measure: Change from baseline sleep at 12 and 24 weeks
  time frame: 12 and 24 weeks
  description: Activpal-derived time spent per day in sleep
  measure: Change from baseline Timed-Up and Go (TUG) test at 12 and 24 weeks
  time frame: 12 and 24 weeks
  description: Functional mobility will be assessed using the TUG test
  measure: Change from baseline functional lower extremity strength at 12 and 24 weeks
  time frame: 12 and 24 weeks
  description: Lower extremity strength will be measured using the 30 seconds sit-stand test
  measure: Change from baseline hand grip strength at 12 and 24 weeks
  time frame: 12 and 24 weeks
  description: Grip strength will be assessed using a dynamometer
  measure: Change from baseline Barthel Index at 12 and 24 weeks
  time frame: 12 and 24 weeks
  description: Level of independence in activities of daily living (ADL) will be assessed using Barthel Index
  measure: Length of hospital stay after surgery to be determined at 12 and 24 weeks
  time frame: 12 and 24 weeks
  description: We will determine the length of stay in the hospital
  measure: Readmission rate to hospital after discharge to be determined at 12 and 24 weeks
  time frame: 12 and 24 weeks
  description: We will determine the hospital readmissions rate within 30 days of discharge.
  measure: Change from baseline Saint Louis University mental status (SLUMS) test
  time frame: 12 and 24 weeks
  description: Cognitive assessment will be completed using the SLUMS test
  measure: Number of participants with reported postoperative complications
  time frame: 12 and 24 weeks
  description: We will determine the number of participants with postoperative complications
  arm group label: Experimental
  arm group type: Experimental
  description: Neuromuscular strength training: The experimental group will receive up to 24 sessions of neuromuscular strength training led by a physical therapist with expertise in geriatrics and movement behaviors. The program includes exercises such as pelvic lifts, lunges, step-ups, squats, and sit-stands. The difficulty level will progressively increase using techniques like manual resistance, dumbbells, and unstable surfaces.
  Sedentary behavior intervention: The experimental group will also undergo a sedentary behavior intervention based on social cognitive theory. It involves weekly coaching sessions to enhance self-efficacy in reducing sedentary time and increasing light-intensity activity throughout the day. Participants will be provided with a wrist-worn Fitbit activity monitor for daily feedback and to track adherence to the intervention. The aim is to encourage participants to "sit less and move more" throughout their waking hours.
  arm group label: Standard of care
  arm group type: No Intervention
  description: The control group will receive standard of care that is provided as part of the perioperative surgical procedure and subsequent rehabilitation.
  intervention type: Behavioral
  intervention name: Combined neuromuscular exercise training and 'sit less, move more' program
  description: Neuromuscular strength training: The experimental group will receive up to 24 sessions of neuromuscular strength training led by a physical therapist with expertise in geriatrics and movement behaviors. The program includes exercises such as pelvic lifts, lunges, step-ups, squats, and sit-stands. The difficulty level will progressively increase using techniques like manual resistance, dumbbells, and unstable surfaces.
  Sedentary behavior intervention: The experimental group will also undergo a sedentary behavior intervention based on social cognitive theory. It involves weekly coaching sessions to enhance self-efficacy in reducing sedentary time and increasing light-intensity activity throughout the day. Participants will be provided with a wrist-worn Fitbit activity monitor for daily feedback and to track adherence to the intervention. The aim is to encourage participants to "sit less and move more" throughout their waking hours.
  arm group label: Experimental
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Naheed Rajabali, MD
  role: Principal Investigator
  affiliation: Alberta Health services
  last name: Victor Ezeugwu, PhD
  role: Principal Investigator
  affiliation: University of Alberta
  last name: Victor E. Ezeugwu, PhD
  phone: 7804925108
  email: ezeugwu@ualberta.ca
  last name: Ritika Sharma
  email: ritika8@ualberta.ca
  facility: 
  country: Canada
  responsible party type: Sponsor-Investigator
  investigator affiliation: University of Alberta
  investigator full name: Victor Ezeugwu
  investigator title: Principal Investigator
  mesh term: Frailty
  sharing ipd: No