The COVID-19 Pandemic and Exercise Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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COvid-19 Pandemic and Exercise (COPE) Trial: A Randomized Study Examining Physical Activities and Wellbeing in Individuals Mandated to Stay at Home

Conditions
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Depressive Symptomatology, Psychological Distress, Health Behavior

Intervention / Treatment
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* Behavioral: Yoga group
* Behavioral: High Intensity Interval Training group
* Behavioral: Combination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 18-64 Still working or pre-retirement Currently completing less than 150 minutes of moderate activity per week, and/or 75 minutes if vigorous activity per week has at-home internet/computer access English speaking Exclusion Criteria: Retired Meeting activity guidelines (i.e. at least 150 min of moderate or 75 min of vigorous intensity exercise per week Major health conditions that limit ability to exercise Hospitalization in the last 3 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga Exercise group<br>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. | Behavioral: Yoga group<br>* At-home yoga exercise instruction provided by a mobile/tablet app or through a computer web browser<br>|
| Experimental: High Intensity Interval Training group<br>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. | Behavioral: High Intensity Interval Training group<br>* At-home HIIT exercise instruction provided by a mobile/tablet app or through a computer web browser<br>|
| Experimental: Combination Yoga & HIIT group<br>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. | Behavioral: Combination<br>* At-home yoga & HIIT exercise instruction provided by a mobile/tablet app or through a computer web browser<br>|
| No Intervention: Control group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in depressive symptomology over the course of the exercise intervention | 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. | Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final CES-D survey at week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in psychological stress as measured by the SCSQ over the course of the exercise intervention. | 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. | Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final survey at week 12 | 
| Changes in psychological distress as measured by the K10 over the course of the exercise intervention. | 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. | Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final survey at week 12 | 
| Changes in flourishing over the course of the exercise intervention | 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. | Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final flourishing survey at week 12 | 
| Changes in resilience over the course of the exercise intervention | 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. | Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final survey at week 12 | 
| Changes in life satisfaction over the course of the exercise intervention | 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. | Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final survey at week 12 | 
| 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. | 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. | Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final survey at week 12 | 
| Changes in general affect over the course of the exercise intervention | 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. | Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final survey at week 12 | 
| Changes in leisure time physical activity over the course of the exercise intervention | 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. | Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final survey at week 12 | 
| Changes in physical health symptomology over the course of the exercise intervention | 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. | Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final survey at week 12 | 
| Changes in alcohol habits over the course of the exercise intervention | 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. | Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final survey at week 12 | 
| Tracking the amount of exercise variety participants feel they engage in | 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. | Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final survey at week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, intervention, resilience, depression, general affect, flourishing, psychological distress