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/NCT06023069</url>
    </required_header>
    <id_info>
      <org_study_id>N32276 PMI/Karolinska</org_study_id>
      <nct_id>NCT06023069</nct_id>
    </id_info>
    <brief_title>Preoperative Walking Evaluation and Postoperative Outcome</brief_title>
    <acronym>PREVENT</acronym>
    <official_title>Preoperative Walking Evaluation and Postoperative Outcome in Non-cardiac Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Karolinska Institutet</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Karolinska Institutet</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>
        Our hypothesis is that physical activity is associated with a reduced risk of complications&#xD;
        and death after surgery.&#xD;
  &#xD;
        Self-reporting of physical activity is prone to be unreliable. In order to obtain a better&#xD;
        picture of patients' physical activity, we intend to investigate the association between the&#xD;
        average number of steps and postoperative outcomes. Many other objective measures of physical&#xD;
        activity are costly and time-consuming to perform; for example, exercise tests, extensive&#xD;
        sampling, and longer questionnaires.&#xD;
  &#xD;
        Our primary research question is: Do patients with a higher degree of physical activity,&#xD;
        measured as the average number of steps recorded on the patient's mobile phone, have a&#xD;
        reduced risk of peri/postoperative complications and death, measured as Days At Home alive at&#xD;
        30 days (DAH30)?&#xD;
  &#xD;
        Secondary research questions include:&#xD;
  &#xD;
        Is physical activity, measured as the average number of steps recorded on the patient's&#xD;
        mobile phone, linearly linked to DAH30? Is physical activity, measured as the average number&#xD;
        of steps recorded on the patient's mobile phone, associated with specific peri/postoperative&#xD;
        organ impact, such as lung, heart, cerebral, infection, or kidney complications? Is physical&#xD;
        activity, measured as the average number of steps recorded on the patient's mobile phone,&#xD;
        also linked to long-term outcomes one year after surgery? Is physical activity, measured as&#xD;
        the average number of steps recorded on the patient's mobile phone, solely associated with&#xD;
        DAH30 and organ complications for specific patient groups in terms of age, comorbidities,&#xD;
        and/or type of surgery?&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Project Description Method This is a non-interventional prospective observational multicenter&#xD;
        study of the association between physical activity and peri/postoperative outcomes, planned&#xD;
        to be conducted in two stages. First, as a pilot study involving multiple participating&#xD;
        anesthesia/surgery clinics. Following this, we plan to analyze data from the mentioned pilot&#xD;
        study and then launch a global multicenter study on a more defined patient group.&#xD;
  &#xD;
        Procedures/Data Collection Preoperatively: We will record age, gender, comorbidities, and&#xD;
        ongoing medication, as well as ASA classification, frailty score, and mDASI (modified Duke&#xD;
        Activity Status Index), which is a measure of functional ability. Routine preoperative&#xD;
        laboratory tests will be noted. Furthermore, we intend to record average physical activity,&#xD;
        including daily step count on average at one, six, and twelve months before surgery, based on&#xD;
        data from the patient's mobile phone*. Type of planned surgery will be recorded.&#xD;
  &#xD;
        *The dominant mobile phones on the market (iOS and Android-based) use different types of&#xD;
        systems to count steps. Some mobile phones completely lack such systems. The validation of&#xD;
        how accurately they count steps per day also varies. We will record the model and operating&#xD;
        system, as well as the type of app used. Not all patients carry their phones all the time; we&#xD;
        intend to register their own estimate of how often it is carried. A few patients do not have&#xD;
        a mobile phone and cannot contribute step per day data.&#xD;
  &#xD;
        Intraoperatively: We will record anesthesia method, operation time (incision time and total&#xD;
        operation time), fluid balance, bleeding, and transfusion requirements, as well as adverse&#xD;
        events such as blood pressure drops, hypoxia, tachycardia.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>DAH30 (Days At Home alive at 30 days)</measure>
      <time_frame>30 days after index surgery</time_frame>
      <description>DAH30: Patients who are hospitalized for 14 days postoperatively but are alive on day 30 will have DAH30=16. Patients who are hospitalized for five days, then discharged, but return after 10 days for an additional 11-day stay, will have DAH30=14. Anyone who dies within 30 days will have DAH30=0. This outcome measure is validated in several studies and has a significant advantage in that it correlates well with complications, even better than length of stay (LOS)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Mortality</measure>
      <time_frame>Mortality will be recorded at 30, 60, 90 and 365 days after index surgery</time_frame>
      <description>Death within the time frames described below</description>
    </secondary_outcome>
    <enrollment type="Anticipated">264</enrollment>
    <condition>General Surgery</condition>
    <condition>Perioperative Medicine</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Number of steps recorded by mobile phone as a proxy for physical activity</intervention_name>
      <description>This cohort is likely to have patients with many steps/day (high activity) and few steps/day (low activity)</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adult patients (equal to or over 18 years) undergoing elective non-cardiac surgery&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Adult patients (equal to or over 18 years) undergoing elective non-cardiac surgery&#xD;
          providing informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Patients that can not provide informed consent.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Max Bell</last_name>
      <role>Principal Investigator</role>
      <affiliation>N32276 PMI/Karolinska</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Max Bell, MD, PhD</last_name>
      <phone>+46708278533</phone>
      <email>max.bell@regionstockholm.se</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
      <investigator_full_name>Max Bell</investigator_full_name>
      <investigator_title>MD, PhD</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT06023069
  org study id: N32276 PMI/Karolinska
  nct id: NCT06023069
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Our hypothesis is that physical activity is associated with a reduced risk of complications
        and death after surgery.
  
        Self-reporting of physical activity is prone to be unreliable. In order to obtain a better
        picture of patients' physical activity, we intend to investigate the association between the
        average number of steps and postoperative outcomes. Many other objective measures of physical
        activity are costly and time-consuming to perform; for example, exercise tests, extensive
        sampling, and longer questionnaires.
  
        Our primary research question is: Do patients with a higher degree of physical activity,
        measured as the average number of steps recorded on the patient's mobile phone, have a
        reduced risk of peri/postoperative complications and death, measured as Days At Home alive at
        30 days (DAH30)?
  
        Secondary research questions include:
  
        Is physical activity, measured as the average number of steps recorded on the patient's
        mobile phone, linearly linked to DAH30? Is physical activity, measured as the average number
        of steps recorded on the patient's mobile phone, associated with specific peri/postoperative
        organ impact, such as lung, heart, cerebral, infection, or kidney complications? Is physical
        activity, measured as the average number of steps recorded on the patient's mobile phone,
        also linked to long-term outcomes one year after surgery? Is physical activity, measured as
        the average number of steps recorded on the patient's mobile phone, solely associated with
        DAH30 and organ complications for specific patient groups in terms of age, comorbidities,
        and/or type of surgery?
  Project Description Method This is a non-interventional prospective observational multicenter
        study of the association between physical activity and peri/postoperative outcomes, planned
        to be conducted in two stages. First, as a pilot study involving multiple participating
        anesthesia/surgery clinics. Following this, we plan to analyze data from the mentioned pilot
        study and then launch a global multicenter study on a more defined patient group.
  
        Procedures/Data Collection Preoperatively: We will record age, gender, comorbidities, and
        ongoing medication, as well as ASA classification, frailty score, and mDASI (modified Duke
        Activity Status Index), which is a measure of functional ability. Routine preoperative
        laboratory tests will be noted. Furthermore, we intend to record average physical activity,
        including daily step count on average at one, six, and twelve months before surgery, based on
        data from the patient's mobile phone*. Type of planned surgery will be recorded.
  
        *The dominant mobile phones on the market (iOS and Android-based) use different types of
        systems to count steps. Some mobile phones completely lack such systems. The validation of
        how accurately they count steps per day also varies. We will record the model and operating
        system, as well as the type of app used. Not all patients carry their phones all the time; we
        intend to register their own estimate of how often it is carried. A few patients do not have
        a mobile phone and cannot contribute step per day data.
  
        Intraoperatively: We will record anesthesia method, operation time (incision time and total
        operation time), fluid balance, bleeding, and transfusion requirements, as well as adverse
        events such as blood pressure drops, hypoxia, tachycardia.
  observational model: Cohort
  time perspective: Prospective
  measure: DAH30 (Days At Home alive at 30 days)
  time frame: 30 days after index surgery
  description: DAH30: Patients who are hospitalized for 14 days postoperatively but are alive on day 30 will have DAH30=16. Patients who are hospitalized for five days, then discharged, but return after 10 days for an additional 11-day stay, will have DAH30=14. Anyone who dies within 30 days will have DAH30=0. This outcome measure is validated in several studies and has a significant advantage in that it correlates well with complications, even better than length of stay (LOS)
  measure: Mortality
  time frame: Mortality will be recorded at 30, 60, 90 and 365 days after index surgery
  description: Death within the time frames described below
  intervention type: Other
  intervention name: Number of steps recorded by mobile phone as a proxy for physical activity
  description: This cohort is likely to have patients with many steps/day (high activity) and few steps/day (low activity)
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Max Bell
  role: Principal Investigator
  affiliation: N32276 PMI/Karolinska
  last name: Max Bell, MD, PhD
  phone: +46708278533
  email: max.bell@regionstockholm.se
  responsible party type: Principal Investigator
  investigator affiliation: Karolinska Institutet
  investigator full name: Max Bell
  investigator title: MD, PhD
  sharing ipd: Undecided