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/NCT06030115</url>
    </required_header>
    <id_info>
      <org_study_id>GoodShepherdIHS</org_study_id>
      <nct_id>NCT06030115</nct_id>
    </id_info>
    <brief_title>Effects of a Hybrid Model of Cardiac Rehabilitation on Patient Outcomes</brief_title>
    <official_title>Effects of a Physical Therapist-driven Individualized Hybrid Model of the Exercise Component of Cardiac Rehabilitation on Patient Outcomes: a Prospective Cohort Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Good Shepherd Integrated Healthcare Systems</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Good Shepherd Integrated Healthcare Systems</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>
        Determine if the standard of care at a cardiac rehabilitation center using what the&#xD;
        investigators term to be &quot;hybrid model&quot; on the exercise component of cardiac rehabilitation&#xD;
        is associated with improved adherence and outcomes. Discuss the hybrid model in comparison to&#xD;
        traditional cardiac rehabilitation and layout a template on how to incorporate this hybrid&#xD;
        model. Discuss factors that may lead to poor adherence and attendance to cardiac&#xD;
        rehabilitation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Purpose: The aim of this prospective cohort study was to determine the effectiveness of an&#xD;
        individualized physical therapist (PT) driven hybrid model of the exercise component of&#xD;
        cardiac rehabilitation (CR) that uses a novel intensity-recovery progression protocol (IRPP)&#xD;
        and cardiac testing template (CTT) to assess achieved heart rate intensity (AHRI%), heart&#xD;
        rate recovery (HRR%), and intensity-recovery total (IR%) as indicators to guide treatment.&#xD;
  &#xD;
        Methods: Assessment of a subjective questionnaire, vital signs, treadmill 6-minute walk&#xD;
        (6MW), 1-minute sit-to-stand (1STS), 1-minute step (1ST), and 1-minute agility square tests&#xD;
        (1AST) were assessed on 100 participants during the 36-visit program. The hybrid model was&#xD;
        led by a PT, was longer in duration, added high intensity interval training (HIIT) to&#xD;
        continuous aerobic exercise training (CAET) and resistance training, and used a 1:1 treatment&#xD;
        ratio. Treatment intensity and progression were measured based on clinical decision making&#xD;
        through the IRPP and CTT.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 1, 2019</start_date>
    <completion_date type="Actual">July 31, 2021</completion_date>
    <primary_completion_date type="Actual">July 31, 2021</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>Six Minute Walk Test</measure>
      <time_frame>Six Minutes</time_frame>
      <description>Treadmill Six Minute Walk Test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Timed Sit To Stand Test</measure>
      <time_frame>One Minute</time_frame>
      <description>A standardized test measuring how many times an individual can stand from a standardized seated position in one minute using hand support to push off.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Timed Step Test</measure>
      <time_frame>One Minute</time_frame>
      <description>A test measuring how many repetitions an individual can go up and down a standardized step while using bilateral arm support on a rail.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Timed Agility Square Test</measure>
      <time_frame>One Minute</time_frame>
      <description>Using agility ladder square to go in and out of designated two boxes</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Achieved Target Heart Rate (AHRI%)</measure>
      <time_frame>One minute</time_frame>
      <description>Heart rate achieved during outcome measurements (six minute walk test, timed sit to stand test, timed step test, timed agility square test). Completed every 5 visits from date of initiation up to 1 year after initiation or until visit 36 achieved (whichever comes first). Participants expected to attend the program at a frequency of 2x a week for 36 total visits.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Heart Rate Recovery (HRR%)</measure>
      <time_frame>One minute</time_frame>
      <description>Heart rate observed one minute after outcome measurements (six minute walk test, timed sit to stand test, timed step test, timed agility square test). Completed every 5 visits from date of initiation up to 1 year after initiation or until visit 36 achieved (whichever comes first).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Intensity Recovery Total Score (IR%)</measure>
      <time_frame>One minute</time_frame>
      <description>The total of the AHRI + HRR during objective measurements (six minute walk test, timed sit to stand test, timed step test, timed agility square test). Completed every 5 visits from date of initiation up to 1 year after initiation or until visit 36 achieved (whichever comes first).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Subjective Questionnaire</measure>
      <time_frame>From date of initiation of study up to 1 year after initiation. Collected on Visit 1, Visit 15, Visit 30 for each participant, who were expected to attend the program at a frequency of 2x a week for 36 total sessions.</time_frame>
      <description>Three questions (where higher scores denote better outcomes) Question 1: Rate your endurance (using a visual analog scale from 0-100% marked every 10%)? Question 2: Estimate how many stairs you could go up using arm support before you would have to take a break? Question 3: Estimate how many hours of exercise you completed in the previous 7 days?</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">100</enrollment>
    <condition>Cardiac Surgery</condition>
    <condition>Coronary Artery Bypass Graft CABG</condition>
    <condition>Stent</condition>
    <condition>Valve Replacement</condition>
    <arm_group>
      <arm_group_label>Cardiac Rehab Patients</arm_group_label>
      <description>All participants referred to the clinic meeting the inclusion and exclusion criteria who wanted to participate in the study.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Exercise Component Of Cardiac Rehabilitation (Hybrid Model) Intensity Recovery Progression Protocol (IRPP)</intervention_name>
      <description>Data collected on participants who completed the intensity recovery progression protocol program</description>
      <arm_group_label>Cardiac Rehab Patients</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The participants analyzed (73 males, 27 females) had an average starting age of 66.1 years&#xD;
          (SD=9.6; range 41-88 years). The admitting diagnoses were 50% stent, 37% CABG, 8% valve&#xD;
          replacement and 5% a combination of the above.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Underwent cardiac surgery (CABG, PCI with stent placement, and valve replacement)&#xD;
  &#xD;
            -  Surgery was within the previous 365 days&#xD;
  &#xD;
            -  Could independently ambulate into the facility.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Implantable cardioverter defibrillator (ICD)&#xD;
  &#xD;
            -  Pacemaker (PPM)&#xD;
  &#xD;
            -  Heart Transplant&#xD;
  &#xD;
            -  Left ventricular assist device (LVAD)&#xD;
  &#xD;
            -  All other cardiac procedures not listed within inclusion criteria&#xD;
  &#xD;
            -  Diagnosed a-fib&#xD;
  &#xD;
            -  Participants who attended cardiac rehabilitation before&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kevin Minchin, DPT</last_name>
      <role>Principal Investigator</role>
      <affiliation>Good Shepherd</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Good Shepherd Integrated Healthcare Systems</name>
        <address>
          <city>Las Vegas</city>
          <state>Nevada</state>
          <zip>89119</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
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    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Good Shepherd Integrated Healthcare Systems</investigator_affiliation>
      <investigator_full_name>Kevin Minchin</investigator_full_name>
      <investigator_title>Physical Therapist, Rehabilitation Director</investigator_title>
    </responsible_party>
    <keyword>Physical Therapy</keyword>
    <keyword>Cardiopulmonary Rehabilitation</keyword>
    <keyword>Cardiac Surgery</keyword>
    <keyword>Exercise</keyword>
    <keyword>Heart Rate</keyword>
    <keyword>Objective Outcome Assessments</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>IPD (decodified) will be stored in a password protected laptop in a locked room in a locked file cabinet at the clinic site. The statistical summarized analysis will be the main focus for the public and other researchers. The cardiac testing template in excel format will be available for other researchers looking to use the hybrid model explained in the study, however, this template will not contain individualized personal data.</ipd_description>
    </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/NCT06030115
  org study id: GoodShepherdIHS
  nct id: NCT06030115
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Determine if the standard of care at a cardiac rehabilitation center using what the
        investigators term to be "hybrid model" on the exercise component of cardiac rehabilitation
        is associated with improved adherence and outcomes. Discuss the hybrid model in comparison to
        traditional cardiac rehabilitation and layout a template on how to incorporate this hybrid
        model. Discuss factors that may lead to poor adherence and attendance to cardiac
        rehabilitation.
  Purpose: The aim of this prospective cohort study was to determine the effectiveness of an
        individualized physical therapist (PT) driven hybrid model of the exercise component of
        cardiac rehabilitation (CR) that uses a novel intensity-recovery progression protocol (IRPP)
        and cardiac testing template (CTT) to assess achieved heart rate intensity (AHRI%), heart
        rate recovery (HRR%), and intensity-recovery total (IR%) as indicators to guide treatment.
  
        Methods: Assessment of a subjective questionnaire, vital signs, treadmill 6-minute walk
        (6MW), 1-minute sit-to-stand (1STS), 1-minute step (1ST), and 1-minute agility square tests
        (1AST) were assessed on 100 participants during the 36-visit program. The hybrid model was
        led by a PT, was longer in duration, added high intensity interval training (HIIT) to
        continuous aerobic exercise training (CAET) and resistance training, and used a 1:1 treatment
        ratio. Treatment intensity and progression were measured based on clinical decision making
        through the IRPP and CTT.
  observational model: Cohort
  time perspective: Prospective
  measure: Six Minute Walk Test
  time frame: Six Minutes
  description: Treadmill Six Minute Walk Test
  measure: Timed Sit To Stand Test
  time frame: One Minute
  description: A standardized test measuring how many times an individual can stand from a standardized seated position in one minute using hand support to push off.
  measure: Timed Step Test
  time frame: One Minute
  description: A test measuring how many repetitions an individual can go up and down a standardized step while using bilateral arm support on a rail.
  measure: Timed Agility Square Test
  time frame: One Minute
  description: Using agility ladder square to go in and out of designated two boxes
  measure: Achieved Target Heart Rate (AHRI%)
  time frame: One minute
  description: Heart rate achieved during outcome measurements (six minute walk test, timed sit to stand test, timed step test, timed agility square test). Completed every 5 visits from date of initiation up to 1 year after initiation or until visit 36 achieved (whichever comes first). Participants expected to attend the program at a frequency of 2x a week for 36 total visits.
  measure: Heart Rate Recovery (HRR%)
  time frame: One minute
  description: Heart rate observed one minute after outcome measurements (six minute walk test, timed sit to stand test, timed step test, timed agility square test). Completed every 5 visits from date of initiation up to 1 year after initiation or until visit 36 achieved (whichever comes first).
  measure: Intensity Recovery Total Score (IR%)
  time frame: One minute
  description: The total of the AHRI + HRR during objective measurements (six minute walk test, timed sit to stand test, timed step test, timed agility square test). Completed every 5 visits from date of initiation up to 1 year after initiation or until visit 36 achieved (whichever comes first).
  measure: Subjective Questionnaire
  time frame: From date of initiation of study up to 1 year after initiation. Collected on Visit 1, Visit 15, Visit 30 for each participant, who were expected to attend the program at a frequency of 2x a week for 36 total sessions.
  description: Three questions (where higher scores denote better outcomes) Question 1: Rate your endurance (using a visual analog scale from 0-100% marked every 10%)? Question 2: Estimate how many stairs you could go up using arm support before you would have to take a break? Question 3: Estimate how many hours of exercise you completed in the previous 7 days?
  arm group label: Cardiac Rehab Patients
  description: All participants referred to the clinic meeting the inclusion and exclusion criteria who wanted to participate in the study.
  intervention type: Other
  intervention name: Exercise Component Of Cardiac Rehabilitation (Hybrid Model) Intensity Recovery Progression Protocol (IRPP)
  description: Data collected on participants who completed the intensity recovery progression protocol program
  arm group label: Cardiac Rehab Patients
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Kevin Minchin, DPT
  role: Principal Investigator
  affiliation: Good Shepherd
  facility: 
  country: United States
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  responsible party type: Principal Investigator
  investigator affiliation: Good Shepherd Integrated Healthcare Systems
  investigator full name: Kevin Minchin
  investigator title: Physical Therapist, Rehabilitation Director
  sharing ipd: No
  ipd description: IPD (decodified) will be stored in a password protected laptop in a locked room in a locked file cabinet at the clinic site. The statistical summarized analysis will be the main focus for the public and other researchers. The cardiac testing template in excel format will be available for other researchers looking to use the hybrid model explained in the study, however, this template will not contain individualized personal data.