<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/NCT04400279</url>
  </required_header>
  <id_info>
    <org_study_id>H20-01497</org_study_id>
    <nct_id>NCT04400279</nct_id>
  </id_info>
  <brief_title>The COVID-19 Pandemic and Exercise Study</brief_title>
  <acronym>COPE</acronym>
  <official_title>COvid-19 Pandemic and Exercise (COPE) Trial: A Randomized Study Examining Physical Activities and Wellbeing in Individuals Mandated to Stay at Home</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of British Columbia</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 COPE Trial is a randomized controlled trial that will provide currently isolated yet&#xD;
      generally physically healthy 18-64 year old adults who are pre-retirement with the&#xD;
      opportunity to receive a free 3-month subscription to either a yoga or moderate-to-high&#xD;
      intensity aerobic exercise app or be randomized to a waitlist control group. Study outcomes&#xD;
      include measures of psychological wellbeing and physical health.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Global stay-at-home mandates implemented in response to the COVID-19 pandemic are having&#xD;
      substantial negative effects on mental health. Developing approaches to maintain the mental&#xD;
      health of all individuals during this unprecedented time of physical distancing is of&#xD;
      paramount importance. In the proposed low cost randomized controlled trial (RCT), the&#xD;
      investigators seek to answer whether the use of a mobile app that provides a variety of&#xD;
      physical activities appropriate for home workouts [i.e., high intensity interval training&#xD;
      (HIIT), yoga] can improve wellbeing and health in adults mandated to stay at home. Should the&#xD;
      results of this trial support the efficacy of the intervention (via app delivery), this has&#xD;
      the potential to be implemented and delivered rapidly and at scale.&#xD;
&#xD;
      Engaging in regular physical activity confers reduced risk for mental disorders (e.g.&#xD;
      depression, anxiety) in clinical and non-clinical populations. The investigators' recent&#xD;
      evidence also suggests that becoming physically active reduces depressive symptoms, as well&#xD;
      as negative affect and rumination on a daily basis, while improving daily positive affect and&#xD;
      a sense of control in highly stressed adults. With fitness centres currently closed by&#xD;
      mandate, becoming physically active during the COVID-19 pandemic could prove to be a&#xD;
      challenge for individuals who are typically inactive, those mandated to stay-at-home, or&#xD;
      those who do not have opportunities to access outdoor spaces that provide the recommended two&#xD;
      meters of distance between people. Thus, the investigators seek to support those living under&#xD;
      stay-at-home mandates with access to mobile apps that provide opportunities to be physically&#xD;
      active in the home environment.&#xD;
&#xD;
      The study will focus on physical activities requiring little physical space or equipment that&#xD;
      are easily completed at home. The study includes yoga, a movement-based activity that&#xD;
      promotes relaxation and mindfulness and only requires space for the full length and width of&#xD;
      one's body, and a mat as equipment. Yoga has been shown to be effective in improving physical&#xD;
      function and quality of life in RCTs. The study also includes whole body weight (WBW)-based&#xD;
      HIIT, which also only requires a mat, making it an excellent home-based form of aerobic&#xD;
      exercise. HIIT is characterized as bouts of high-intensity exercise combined with periods of&#xD;
      recovery or lower intensity activity. Its physical and psychological benefits compared to&#xD;
      continuous moderate intensity training are often evidenced to be equal or significantly&#xD;
      stronger.&#xD;
&#xD;
      Aims. The primary outcome will be a measure of depressive symptomology. It is hypothesized&#xD;
      that those who actively use the yoga and/or WBW-HIIT mobile apps will improve in their&#xD;
      depressive symptomatology compared to the waitlist control group over the course of the&#xD;
      6-week RCT. The study will also include measures of, as secondary outcomes, psychological&#xD;
      distress, quality of life, and self-reported physical health, and expect decreases in&#xD;
      distress and increases in the remaining outcomes. The researchers will also investigate&#xD;
      whether effects are stronger in those (a) who currently live alone vs. live with others, or&#xD;
      (b) with poorer levels of psychological health pre-randomization.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Actual">November 28, 2020</completion_date>
  <primary_completion_date type="Actual">November 28, 2020</primary_completion_date>
  <phase>N/A</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>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>PI will be blind to the allocation to the groups. Person sending out emails to participants to complete surveys will be blind to group allocation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in depressive symptomology over the course of the exercise intervention</measure>
    <time_frame>Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final CES-D survey at week 12</time_frame>
    <description>The 10 Item Center for Epidemiologic Studies Depression Scale (CES-D) will be used in the baseline survey, and will be in each weekly survey to track changes in the CES-D over the study period. The possible range in scores is 0 to 30 depending on number of symptoms, with those symptoms weighted by frequency experienced in a week. Higher scores indicating more or more frequent symptoms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in psychological stress as measured by the SCSQ over the course of the exercise intervention.</measure>
    <time_frame>Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final survey at week 12</time_frame>
    <description>The 1 Item Statistics Canada Stress Question (SCSQ) will be used in the baseline survey and in each weekly survey to track changes in psychological stress over the study period. The SCSQ is a 1-item question with a possible scoring of 0 to 10, with higher scores indicating more stress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in psychological distress as measured by the K10 over the course of the exercise intervention.</measure>
    <time_frame>Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final survey at week 12</time_frame>
    <description>The 10 Item Kessler Psychological Distress Scale (K10) will be used in the baseline survey and in each weekly survey to track changes in psychological distress over the study period. The K10 measures general psychological distress, typically over the last 30 days, but the investigators will be using the survey on a weekly basis to track changes potentially related to the exercise intervention. Scores range from 10-50, with higher scores indicating more symptoms or more frequent experience of those symptoms. Scores are weighted by how often the symptoms are experienced in a period of time, which in this case is the previous 7 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in flourishing over the course of the exercise intervention</measure>
    <time_frame>Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final flourishing survey at week 12</time_frame>
    <description>Diener's Flourishing scale will be used in the baseline survey, and will be in each weekly survey to track changes in flourishing over the study period. There are 8 items, phrased in a positive direction. Scores can range from 8 (strong disagreement with all items) to 56 (strong agreement with all items), with higher scores indicating individuals who have a more positive view of themselves in important areas of functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in resilience over the course of the exercise intervention</measure>
    <time_frame>Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final survey at week 12</time_frame>
    <description>The Brief Resilience Scale (BRS) will be used in the baseline survey, and will be in each weekly survey to track changes in resilience over the study period. The BRS uses a mean scoring system with a possible range in scores from 1-5, higher scores indicate the individual perceives they have a better ability to 'bounce back' and recover from stressful events and/or situations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in life satisfaction over the course of the exercise intervention</measure>
    <time_frame>Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final survey at week 12</time_frame>
    <description>A Life Satisfaction item, consisting of three questions, will be used in the baseline and weekly surveys to track changes over the study period. The first item is scored 0-10, with 10 indicating &quot;the best possible life overall&quot;. Two follow-up questions asking individuals to rate their physical and mental/emotional health on a five point scale from poor to excellent. Higher scores overall indicate more satisfaction with life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in weekly strain as a result of health problems, financial/work issues, and relationship trouble using the Chronic Burden Scale over the course of the exercise intervention.</measure>
    <time_frame>Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final survey at week 12</time_frame>
    <description>The Chronic Burden Scale (CBS) is an eight-item question asking about how much perceived strain individuals have experienced over the last week. This includes health problems with themselves, family members, and/or others close to them; problems with their job or ability to work; financial strain; and problems with relationships. There is a possible score of 8-32, with lower scores indicating less perceived strain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in general affect over the course of the exercise intervention</measure>
    <time_frame>Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final survey at week 12</time_frame>
    <description>Using the positive and negative affect scale and a scale developed by Mroczek and Kolarz (1998) the investigators will be tracking participants affect. There are 25 items, scored 1 (felt all the time) to 5 (felt none of the time), with 13 negative affect and 18 positive affect items. PANAS Positive and negative affect will be considered separately, as will the positive items from Mroczek and Kolarz's measure, such that in each case higher scores will indicate higher amounts of positive or negative affect, respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in leisure time physical activity over the course of the exercise intervention</measure>
    <time_frame>Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final survey at week 12</time_frame>
    <description>The investigators are tracking leisure time physical activity at baseline, and weekly (outside of the exercise intervention) using a version of the leisure score index (LSI) that was modified from the original LSI that was part of Godin's Leisure Time Exercise Questionnaire (GLTEQ). This question is open-ended and allows participants to tell us the frequency per week and time per exercise session of any mild, moderate, or strenuous exercise the participants have completed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in physical health symptomology over the course of the exercise intervention</measure>
    <time_frame>Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final survey at week 12</time_frame>
    <description>A Physical Health item will be used in the baseline and weekly surveys to track changes in physical health (e.g. headache, backache, fever, sore throat, fatigue etc.) over the course of the study period. There are 13 physical symptoms, with the scoring based on how many symptoms were experienced in the past week. The scoring range is 0-13, with higher numbers indicating experiencing more negative physical health symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in alcohol habits over the course of the exercise intervention</measure>
    <time_frame>Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final survey at week 12</time_frame>
    <description>Using a 2-item alcohol habits question the investigators are tracking any changes in participants alcohol behaviours. Participants are asked if they drank at all in the last week, and if so, how many days per week they consumed alcohol. This is a modified version of the CDC's Behavioural Risk Factor Surveillance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tracking the amount of exercise variety participants feel they engage in</measure>
    <time_frame>Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final survey at week 12</time_frame>
    <description>Using the Perceived Variety in Exercise (PVE) questionnaire, the investigators are tracking how varied participants feel their exercise activities are. There are 5 items asking about exercise variety, scored 1 (false) to 6 (true), with a possible score of 5-30; higher scores indicate greater perceived variety.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">334</enrollment>
  <condition>Depressive Symptomatology</condition>
  <condition>Psychological Distress</condition>
  <condition>Health Behavior</condition>
  <arm_group>
    <arm_group_label>Yoga Exercise group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Using the Down Dog app, this group will be given access to an at-home personalized yoga practice, unique every time the participants complete it. Asked to complete yoga practice 4 times per week for 6 weeks. Weekly surveys will be administered to monitor wellbeing and health throughout the intervention. The second 6 weeks of the study, participants will have continued access to the Down Dog app and a final wellbeing and health survey will be administered at the end of the second 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High Intensity Interval Training group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Using the Down Dog app, this group will be given access to at-home bodyweight high intensity interval training (HIIT) workouts. Asked to complete these HIIT workouts 4 times per week for 6 weeks. Weekly surveys will be administered to monitor wellbeing and health throughout the intervention. The second 6 weeks of the study, participants will have continued access to the Down Dog app and a final wellbeing and health survey will be administered at the end of the second 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Combination Yoga &amp; HIIT group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Using the Down Dog app, this group will be given access to both the unique yoga practice and bodyweight HIIT workouts. Asked to complete 2 yoga and 2 HIIT workouts per week. Weekly surveys will be administered to monitor wellbeing and health throughout the intervention. The second 6 weeks of the study, participants will have continued access to the Down Dog app and a final wellbeing and health survey will be administered at the end of the second 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group will be maintaining their pre-study activity levels for the first 6 weeks of the study. Weekly surveys will be administered to monitor wellbeing and health throughout the intervention. Then the participants will be given access to all the Down Dog apps (both yoga and HIIT included) to use as the participants please for the following 6 weeks. A final wellbeing and health survey at the end of the second 6 weeks will be administered.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Yoga group</intervention_name>
    <description>At-home yoga exercise instruction provided by a mobile/tablet app or through a computer web browser</description>
    <arm_group_label>Yoga Exercise group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>High Intensity Interval Training group</intervention_name>
    <description>At-home HIIT exercise instruction provided by a mobile/tablet app or through a computer web browser</description>
    <arm_group_label>High Intensity Interval Training group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Combination</intervention_name>
    <description>At-home yoga &amp; HIIT exercise instruction provided by a mobile/tablet app or through a computer web browser</description>
    <arm_group_label>Combination Yoga &amp; HIIT group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between 18-64&#xD;
&#xD;
          -  Still working or pre-retirement&#xD;
&#xD;
          -  Currently completing less than 150 minutes of moderate activity per week, and/or 75&#xD;
             minutes if vigorous activity per week&#xD;
&#xD;
          -  has at-home internet/computer access&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Retired&#xD;
&#xD;
          -  Meeting activity guidelines (i.e. at least 150 min of moderate or 75 min of vigorous&#xD;
             intensity exercise per week&#xD;
&#xD;
          -  Major health conditions that limit ability to exercise&#xD;
&#xD;
          -  Hospitalization in the last 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of British Columbia</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6T1Z4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
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  <verification_date>January 2021</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>January 8, 2021</last_update_submitted>
  <last_update_submitted_qc>January 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>Eli Puterman</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>exercise</keyword>
  <keyword>intervention</keyword>
  <keyword>resilience</keyword>
  <keyword>depression</keyword>
  <keyword>general affect</keyword>
  <keyword>flourishing</keyword>
  <keyword>psychological distress</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>Yes</sharing_ipd>
    <ipd_description>All of the individual participant data collected during the trial, after de-identification upon request and cleared for approval by principal investigator.&#xD;
All of the protocols, statistical analysis plan, informed consent form, analytic code.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>4 months following trial's end, materials will be made available. following publication, all data will be made available.</ipd_time_frame>
    <ipd_access_criteria>Investigators whose proposed use of the data has been approved by an independent review committee identified for the purpose for the purpose of meta-analyses and to achieve aims in the approved proposal. Investigators of the study need to approve the proposals. Proposals should be directed to eli.puterman@Ubc.ca</ipd_access_criteria>
    <ipd_url>https://osf.io/g9xqp</ipd_url>
  </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/NCT04400279
org study id: H20-01497
nct id: NCT04400279
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The COPE Trial is a randomized controlled trial that will provide currently isolated yet
      generally physically healthy 18-64 year old adults who are pre-retirement with the
      opportunity to receive a free 3-month subscription to either a yoga or moderate-to-high
      intensity aerobic exercise app or be randomized to a waitlist control group. Study outcomes
      include measures of psychological wellbeing and physical health.
Global stay-at-home mandates implemented in response to the COVID-19 pandemic are having
      substantial negative effects on mental health. Developing approaches to maintain the mental
      health of all individuals during this unprecedented time of physical distancing is of
      paramount importance. In the proposed low cost randomized controlled trial (RCT), the
      investigators seek to answer whether the use of a mobile app that provides a variety of
      physical activities appropriate for home workouts [i.e., high intensity interval training
      (HIIT), yoga] can improve wellbeing and health in adults mandated to stay at home. Should the
      results of this trial support the efficacy of the intervention (via app delivery), this has
      the potential to be implemented and delivered rapidly and at scale.

      Engaging in regular physical activity confers reduced risk for mental disorders (e.g.
      depression, anxiety) in clinical and non-clinical populations. The investigators' recent
      evidence also suggests that becoming physically active reduces depressive symptoms, as well
      as negative affect and rumination on a daily basis, while improving daily positive affect and
      a sense of control in highly stressed adults. With fitness centres currently closed by
      mandate, becoming physically active during the COVID-19 pandemic could prove to be a
      challenge for individuals who are typically inactive, those mandated to stay-at-home, or
      those who do not have opportunities to access outdoor spaces that provide the recommended two
      meters of distance between people. Thus, the investigators seek to support those living under
      stay-at-home mandates with access to mobile apps that provide opportunities to be physically
      active in the home environment.

      The study will focus on physical activities requiring little physical space or equipment that
      are easily completed at home. The study includes yoga, a movement-based activity that
      promotes relaxation and mindfulness and only requires space for the full length and width of
      one's body, and a mat as equipment. Yoga has been shown to be effective in improving physical
      function and quality of life in RCTs. The study also includes whole body weight (WBW)-based
      HIIT, which also only requires a mat, making it an excellent home-based form of aerobic
      exercise. HIIT is characterized as bouts of high-intensity exercise combined with periods of
      recovery or lower intensity activity. Its physical and psychological benefits compared to
      continuous moderate intensity training are often evidenced to be equal or significantly
      stronger.

      Aims. The primary outcome will be a measure of depressive symptomology. It is hypothesized
      that those who actively use the yoga and/or WBW-HIIT mobile apps will improve in their
      depressive symptomatology compared to the waitlist control group over the course of the
      6-week RCT. The study will also include measures of, as secondary outcomes, psychological
      distress, quality of life, and self-reported physical health, and expect decreases in
      distress and increases in the remaining outcomes. The researchers will also investigate
      whether effects are stronger in those (a) who currently live alone vs. live with others, or
      (b) with poorer levels of psychological health pre-randomization.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
masking description: PI will be blind to the allocation to the groups. Person sending out emails to participants to complete surveys will be blind to group allocation.
measure: Changes in depressive symptomology over the course of the exercise intervention
time frame: Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final CES-D survey at week 12
description: The 10 Item Center for Epidemiologic Studies Depression Scale (CES-D) will be used in the baseline survey, and will be in each weekly survey to track changes in the CES-D over the study period. The possible range in scores is 0 to 30 depending on number of symptoms, with those symptoms weighted by frequency experienced in a week. Higher scores indicating more or more frequent symptoms.
measure: Changes in psychological stress as measured by the SCSQ over the course of the exercise intervention.
time frame: Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final survey at week 12
description: The 1 Item Statistics Canada Stress Question (SCSQ) will be used in the baseline survey and in each weekly survey to track changes in psychological stress over the study period. The SCSQ is a 1-item question with a possible scoring of 0 to 10, with higher scores indicating more stress.
measure: Changes in psychological distress as measured by the K10 over the course of the exercise intervention.
time frame: Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final survey at week 12
description: The 10 Item Kessler Psychological Distress Scale (K10) will be used in the baseline survey and in each weekly survey to track changes in psychological distress over the study period. The K10 measures general psychological distress, typically over the last 30 days, but the investigators will be using the survey on a weekly basis to track changes potentially related to the exercise intervention. Scores range from 10-50, with higher scores indicating more symptoms or more frequent experience of those symptoms. Scores are weighted by how often the symptoms are experienced in a period of time, which in this case is the previous 7 days.
measure: Changes in flourishing over the course of the exercise intervention
time frame: Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final flourishing survey at week 12
description: Diener's Flourishing scale will be used in the baseline survey, and will be in each weekly survey to track changes in flourishing over the study period. There are 8 items, phrased in a positive direction. Scores can range from 8 (strong disagreement with all items) to 56 (strong agreement with all items), with higher scores indicating individuals who have a more positive view of themselves in important areas of functioning.
measure: Changes in resilience over the course of the exercise intervention
time frame: Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final survey at week 12
description: The Brief Resilience Scale (BRS) will be used in the baseline survey, and will be in each weekly survey to track changes in resilience over the study period. The BRS uses a mean scoring system with a possible range in scores from 1-5, higher scores indicate the individual perceives they have a better ability to 'bounce back' and recover from stressful events and/or situations.
measure: Changes in life satisfaction over the course of the exercise intervention
time frame: Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final survey at week 12
description: A Life Satisfaction item, consisting of three questions, will be used in the baseline and weekly surveys to track changes over the study period. The first item is scored 0-10, with 10 indicating "the best possible life overall". Two follow-up questions asking individuals to rate their physical and mental/emotional health on a five point scale from poor to excellent. Higher scores overall indicate more satisfaction with life.
measure: Changes in weekly strain as a result of health problems, financial/work issues, and relationship trouble using the Chronic Burden Scale over the course of the exercise intervention.
time frame: Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final survey at week 12
description: The Chronic Burden Scale (CBS) is an eight-item question asking about how much perceived strain individuals have experienced over the last week. This includes health problems with themselves, family members, and/or others close to them; problems with their job or ability to work; financial strain; and problems with relationships. There is a possible score of 8-32, with lower scores indicating less perceived strain.
measure: Changes in general affect over the course of the exercise intervention
time frame: Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final survey at week 12
description: Using the positive and negative affect scale and a scale developed by Mroczek and Kolarz (1998) the investigators will be tracking participants affect. There are 25 items, scored 1 (felt all the time) to 5 (felt none of the time), with 13 negative affect and 18 positive affect items. PANAS Positive and negative affect will be considered separately, as will the positive items from Mroczek and Kolarz's measure, such that in each case higher scores will indicate higher amounts of positive or negative affect, respectively.
measure: Changes in leisure time physical activity over the course of the exercise intervention
time frame: Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final survey at week 12
description: The investigators are tracking leisure time physical activity at baseline, and weekly (outside of the exercise intervention) using a version of the leisure score index (LSI) that was modified from the original LSI that was part of Godin's Leisure Time Exercise Questionnaire (GLTEQ). This question is open-ended and allows participants to tell us the frequency per week and time per exercise session of any mild, moderate, or strenuous exercise the participants have completed.
measure: Changes in physical health symptomology over the course of the exercise intervention
time frame: Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final survey at week 12
description: A Physical Health item will be used in the baseline and weekly surveys to track changes in physical health (e.g. headache, backache, fever, sore throat, fatigue etc.) over the course of the study period. There are 13 physical symptoms, with the scoring based on how many symptoms were experienced in the past week. The scoring range is 0-13, with higher numbers indicating experiencing more negative physical health symptoms.
measure: Changes in alcohol habits over the course of the exercise intervention
time frame: Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final survey at week 12
description: Using a 2-item alcohol habits question the investigators are tracking any changes in participants alcohol behaviours. Participants are asked if they drank at all in the last week, and if so, how many days per week they consumed alcohol. This is a modified version of the CDC's Behavioural Risk Factor Surveillance.
measure: Tracking the amount of exercise variety participants feel they engage in
time frame: Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final survey at week 12
description: Using the Perceived Variety in Exercise (PVE) questionnaire, the investigators are tracking how varied participants feel their exercise activities are. There are 5 items asking about exercise variety, scored 1 (false) to 6 (true), with a possible score of 5-30; higher scores indicate greater perceived variety.
arm group label: Yoga Exercise group
arm group type: Experimental
description: Using the Down Dog app, this group will be given access to an at-home personalized yoga practice, unique every time the participants complete it. Asked to complete yoga practice 4 times per week for 6 weeks. Weekly surveys will be administered to monitor wellbeing and health throughout the intervention. The second 6 weeks of the study, participants will have continued access to the Down Dog app and a final wellbeing and health survey will be administered at the end of the second 6 weeks.
arm group label: High Intensity Interval Training group
arm group type: Experimental
description: Using the Down Dog app, this group will be given access to at-home bodyweight high intensity interval training (HIIT) workouts. Asked to complete these HIIT workouts 4 times per week for 6 weeks. Weekly surveys will be administered to monitor wellbeing and health throughout the intervention. The second 6 weeks of the study, participants will have continued access to the Down Dog app and a final wellbeing and health survey will be administered at the end of the second 6 weeks.
arm group label: Combination Yoga & HIIT group
arm group type: Experimental
description: Using the Down Dog app, this group will be given access to both the unique yoga practice and bodyweight HIIT workouts. Asked to complete 2 yoga and 2 HIIT workouts per week. Weekly surveys will be administered to monitor wellbeing and health throughout the intervention. The second 6 weeks of the study, participants will have continued access to the Down Dog app and a final wellbeing and health survey will be administered at the end of the second 6 weeks.
arm group label: Control group
arm group type: No Intervention
description: This group will be maintaining their pre-study activity levels for the first 6 weeks of the study. Weekly surveys will be administered to monitor wellbeing and health throughout the intervention. Then the participants will be given access to all the Down Dog apps (both yoga and HIIT included) to use as the participants please for the following 6 weeks. A final wellbeing and health survey at the end of the second 6 weeks will be administered.
intervention type: Behavioral
intervention name: Yoga group
description: At-home yoga exercise instruction provided by a mobile/tablet app or through a computer web browser
arm group label: Yoga Exercise group
intervention type: Behavioral
intervention name: High Intensity Interval Training group
description: At-home HIIT exercise instruction provided by a mobile/tablet app or through a computer web browser
arm group label: High Intensity Interval Training group
intervention type: Behavioral
intervention name: Combination
description: At-home yoga & HIIT exercise instruction provided by a mobile/tablet app or through a computer web browser
arm group label: Combination Yoga & HIIT group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Canada
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PMID: 32304649
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PMID: 26606383
citation: Stubbs B, Vancampfort D, Rosenbaum S, Firth J, Cosco T, Veronese N, Salum GA, Schuch FB. An examination of the anxiolytic effects of exercise for people with anxiety and stress-related disorders: A meta-analysis. Psychiatry Res. 2017 Mar;249:102-108. doi: 10.1016/j.psychres.2016.12.020. Epub 2017 Jan 6.
PMID: 28088704
citation: Schuch FB, Vancampfort D, Richards J, Rosenbaum S, Ward PB, Stubbs B. Exercise as a treatment for depression: A meta-analysis adjusting for publication bias. J Psychiatr Res. 2016 Jun;77:42-51. doi: 10.1016/j.jpsychires.2016.02.023. Epub 2016 Mar 4.
PMID: 26978184
citation: Hives BA, Buckler EJ, Weiss J, Schilf S, Johansen KL, Epel ES, Puterman E. The Effects of Aerobic Exercise on Psychological Functioning in Family Caregivers: Secondary Analyses of a Randomized Controlled Trial. Ann Behav Med. 2021 Feb 12;55(1):65-76. doi: 10.1093/abm/kaaa031.
PMID: 32421163
citation: Caplin A, Beauchamp MR, Weiss J, Schilf S, Hives B, DeLongis A, Johansen KL, Epel ES, Puterman E. Effects of Aerobic Exercise Training on Daily Psychological Processes in Family Caregivers: Secondary Analyses of a Randomized Controlled Trial. Affect Sci. 2021 Jan 28;2(1):48-57. doi: 10.1007/s42761-020-00026-6. eCollection 2021 Mar.
PMID: 36042918
citation: Sivaramakrishnan D, Fitzsimons C, Kelly P, Ludwig K, Mutrie N, Saunders DH, Baker G. The effects of yoga compared to active and inactive controls on physical function and health related quality of life in older adults- systematic review and meta-analysis of randomised controlled trials. Int J Behav Nutr Phys Act. 2019 Apr 5;16(1):33. doi: 10.1186/s12966-019-0789-2.
PMID: 30953508
citation: Buchheit M, Laursen PB. High-intensity interval training, solutions to the programming puzzle: Part I: cardiopulmonary emphasis. Sports Med. 2013 May;43(5):313-38. doi: 10.1007/s40279-013-0029-x.
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citation: Ramos JS, Dalleck LC, Tjonna AE, Beetham KS, Coombes JS. The impact of high-intensity interval training versus moderate-intensity continuous training on vascular function: a systematic review and meta-analysis. Sports Med. 2015 May;45(5):679-92. doi: 10.1007/s40279-015-0321-z.
PMID: 25771785
citation: Shepherd SO, Wilson OJ, Taylor AS, Thogersen-Ntoumani C, Adlan AM, Wagenmakers AJ, Shaw CS. Low-Volume High-Intensity Interval Training in a Gym Setting Improves Cardio-Metabolic and Psychological Health. PLoS One. 2015 Sep 24;10(9):e0139056. doi: 10.1371/journal.pone.0139056. eCollection 2015.
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responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: Eli Puterman
investigator title: Assistant Professor
mesh term: COVID-19
sharing ipd: Yes
ipd description: All of the individual participant data collected during the trial, after de-identification upon request and cleared for approval by principal investigator.
All of the protocols, statistical analysis plan, informed consent form, analytic code.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: 4 months following trial's end, materials will be made available. following publication, all data will be made available.
ipd access criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for the purpose for the purpose of meta-analyses and to achieve aims in the approved proposal. Investigators of the study need to approve the proposals. Proposals should be directed to eli.puterman@Ubc.ca
ipd url: https://osf.io/g9xqp