<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/NCT04501432</url>
  </required_header>
  <id_info>
    <org_study_id>23_CODIS</org_study_id>
    <nct_id>NCT04501432</nct_id>
  </id_info>
  <brief_title>Cardiac Rehabilitation and Ongoing Physical Activity During COVID-19</brief_title>
  <acronym>CODIS</acronym>
  <official_title>Cardiac Rehabilitation and Ongoing Physical Activity During the Coronavirus Disease (COVID-19) Pandemic: An Exploratory Mixed-Methods Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ludwig Boltzmann Institute for Digital Health and Prevention</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institute of Sports Medicine, Prevention and Rehabilitation, Salzburg, Austria</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ludwig Boltzmann Institute for Digital Health and Prevention</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 current Coronavirus Disease 2019 (COVID-19) pandemic has resulted in extraordinary public&#xD;
      health orders of social distancing and self-isolation, leading to widespread disruption and&#xD;
      discontinuation of cardiac rehabilitation programmes and other social opportunities for&#xD;
      cardiovascular disease (CVD) patients to exercise. In Austria, the government initiated&#xD;
      drastic public health measures (national lockdown) on March 16, 2020, leading to closure of&#xD;
      all outpatient cardiac rehabilitation facilities and restriction of inpatient rehabilitation&#xD;
      to patients with urgent medical indications only.&#xD;
&#xD;
      This study aims to explore the impact of COVID-19-related national lockdown and public health&#xD;
      restrictions on cardiac rehabilitation patients, with respect to maintenance of physical&#xD;
      activity for secondary CVD prevention.&#xD;
&#xD;
      The study poses three research questions, which will be addressed in a mixed-methods study&#xD;
      with sequential quantitative-qualitative (QUANT-QUAL) design:&#xD;
&#xD;
        1. What was the impact of the COVID-19-related lockdown on patients' physical activity and&#xD;
           physical fitness levels? (QUANT stage)&#xD;
&#xD;
        2. What was the patient experience of the closure of group-based cardiac rehabilitation&#xD;
           training due to COVID-19 public health restrictions? (QUAL stage)&#xD;
&#xD;
        3. Which insights and learning points may be drawn from patients' experiences during&#xD;
           COVID-19 public health restrictions with respect to the provision of home-based digital&#xD;
           support for physical activity? (QUAL stage)&#xD;
&#xD;
      The study will recruit a cohort of up to 40 cardiac rehabilitation patients from one&#xD;
      outpatient cardiac rehabilitation centre in Salzburg, Austria, whose rehabilitation programme&#xD;
      was interrupted by COVID-19 public health orders, including &quot;lockdown&quot;.&#xD;
&#xD;
      Patients will undergo re-assessment of physical fitness in cycle ergometry test and&#xD;
      re-assessment of cardiovascular risk profile. This will be compared with patients' most&#xD;
      recent available test results from before the COVID-19 lockdown (i.e. prior to mid-March&#xD;
      2020) from patient records. Additionally, patients will take part in a semi-structured&#xD;
      qualitative interview in which they will be invited to reflect on their personal experiences&#xD;
      during the COVID-19 lockdown and thereafter.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 14, 2020</start_date>
  <completion_date type="Actual">October 24, 2020</completion_date>
  <primary_completion_date type="Actual">October 24, 2020</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Work load (W)</measure>
    <time_frame>up to 12 months</time_frame>
    <description>Maximal work load (W) achieved in cycle ergometry test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Work load % of predicted value</measure>
    <time_frame>up to 12 months</time_frame>
    <description>Maximal work load (W) achieved in cycle ergometry test expressed as percentage of predicted value</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart rate (bpm)</measure>
    <time_frame>up to 12 months</time_frame>
    <description>Maximal heart rate (bpm) during cycle ergometry test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Framingham Recurrent Coronary Heart Disease risk score</measure>
    <time_frame>up to 12 months</time_frame>
    <description>Range 1% to 29%, higher percentage indicating worse risk estimate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Metabolic Equivalent (MET) minutes / week</measure>
    <time_frame>up to 12 months</time_frame>
    <description>MET-minutes/week calculated from patient self-report of physical activity (International Physical Activity Questionnaire, IPAQ, 7 day version)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Experience</measure>
    <time_frame>5 months</time_frame>
    <description>Semi-structured qualitative interview</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">27</enrollment>
  <condition>Cardiac Rehabilitation</condition>
  <arm_group>
    <arm_group_label>Cardiac Rehabilitation</arm_group_label>
    <description>Participants will be recruited from a group of patients who regularly attended group-based cardiac rehabilitation exercise training at the study site until COVID-19 restrictions (national lockdown) came into force on 16th March 2020.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>This study does not include an intervention</description>
    <arm_group_label>Cardiac Rehabilitation</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        A group of patients who regularly attended group-based cardiac rehabilitation exercise&#xD;
        training at the study site until COVID-19 restrictions (national lockdown) came into force&#xD;
        on 16th March 2020.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults (18 years and over)&#xD;
&#xD;
          -  Cardiovascular disease (CVD)&#xD;
&#xD;
          -  Currently enrolled in outpatient cardiac rehabilitation training at the study site&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications for cardiopulmonary exercise testing&#xD;
&#xD;
          -  Pathologies limiting exercise performance&#xD;
&#xD;
          -  Pregnancy or breastfeeding&#xD;
&#xD;
          -  Limited German language&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Stefan T Kulnik, PhD MRes</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ludwig Boltzmann Institute for Digital Health and Prevention</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute of Sports Medicine, Prevention and Rehabilitation</name>
      <address>
        <city>Salzburg</city>
        <zip>5020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>December 15, 2021</last_update_submitted>
  <last_update_submitted_qc>December 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>Exercise Tolerance</keyword>
  <keyword>Physical Activity</keyword>
  <keyword>Qualitative Interview</keyword>
  <keyword>Secondary Prevention</keyword>
  <keyword>Social Distancing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</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/NCT04501432
org study id: 23_CODIS
nct id: NCT04501432
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The current Coronavirus Disease 2019 (COVID-19) pandemic has resulted in extraordinary public
      health orders of social distancing and self-isolation, leading to widespread disruption and
      discontinuation of cardiac rehabilitation programmes and other social opportunities for
      cardiovascular disease (CVD) patients to exercise. In Austria, the government initiated
      drastic public health measures (national lockdown) on March 16, 2020, leading to closure of
      all outpatient cardiac rehabilitation facilities and restriction of inpatient rehabilitation
      to patients with urgent medical indications only.

      This study aims to explore the impact of COVID-19-related national lockdown and public health
      restrictions on cardiac rehabilitation patients, with respect to maintenance of physical
      activity for secondary CVD prevention.

      The study poses three research questions, which will be addressed in a mixed-methods study
      with sequential quantitative-qualitative (QUANT-QUAL) design:

        1. What was the impact of the COVID-19-related lockdown on patients' physical activity and
           physical fitness levels? (QUANT stage)

        2. What was the patient experience of the closure of group-based cardiac rehabilitation
           training due to COVID-19 public health restrictions? (QUAL stage)

        3. Which insights and learning points may be drawn from patients' experiences during
           COVID-19 public health restrictions with respect to the provision of home-based digital
           support for physical activity? (QUAL stage)

      The study will recruit a cohort of up to 40 cardiac rehabilitation patients from one
      outpatient cardiac rehabilitation centre in Salzburg, Austria, whose rehabilitation programme
      was interrupted by COVID-19 public health orders, including "lockdown".

      Patients will undergo re-assessment of physical fitness in cycle ergometry test and
      re-assessment of cardiovascular risk profile. This will be compared with patients' most
      recent available test results from before the COVID-19 lockdown (i.e. prior to mid-March
      2020) from patient records. Additionally, patients will take part in a semi-structured
      qualitative interview in which they will be invited to reflect on their personal experiences
      during the COVID-19 lockdown and thereafter.
observational model: Cohort
time perspective: Other
measure: Work load (W)
time frame: up to 12 months
description: Maximal work load (W) achieved in cycle ergometry test
measure: Work load % of predicted value
time frame: up to 12 months
description: Maximal work load (W) achieved in cycle ergometry test expressed as percentage of predicted value
measure: Heart rate (bpm)
time frame: up to 12 months
description: Maximal heart rate (bpm) during cycle ergometry test
measure: Framingham Recurrent Coronary Heart Disease risk score
time frame: up to 12 months
description: Range 1% to 29%, higher percentage indicating worse risk estimate
measure: Metabolic Equivalent (MET) minutes / week
time frame: up to 12 months
description: MET-minutes/week calculated from patient self-report of physical activity (International Physical Activity Questionnaire, IPAQ, 7 day version)
measure: Patient Experience
time frame: 5 months
description: Semi-structured qualitative interview
arm group label: Cardiac Rehabilitation
description: Participants will be recruited from a group of patients who regularly attended group-based cardiac rehabilitation exercise training at the study site until COVID-19 restrictions (national lockdown) came into force on 16th March 2020.
intervention type: Other
intervention name: No intervention
description: This study does not include an intervention
arm group label: Cardiac Rehabilitation
Blood samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Stefan T Kulnik, PhD MRes
role: Principal Investigator
affiliation: Ludwig Boltzmann Institute for Digital Health and Prevention
facility: 
country: Austria
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No