Clinical trial NCT04400279: The COVID-19 Pandemic and Exercise Study
Official title: COvid-19 Pandemic and Exercise (COPE) Trial: A Randomized Study Examining Physical Activities and Wellbeing in Individuals Mandated to Stay at Home
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptomatology
Psychological Distress
Health Behavior
Keywords: exercise
intervention
resilience
depression
general affect
flourishing
psychological distress
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2020-05-22
Enrollment: 334
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in depressive symptomology over the course of the exercise intervention
timeFrame: Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final CES-D survey at week 12
Secondary outcomes:
measure: Changes in psychological stress as measured by the SCSQ over the course of the exercise intervention.
timeFrame: Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final survey at week 12
measure: Changes in psychological distress as measured by the K10 over the course of the exercise intervention.
timeFrame: Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final survey at week 12
measure: Changes in flourishing over the course of the exercise intervention
timeFrame: Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final flourishing survey at week 12
measure: Changes in resilience over the course of the exercise intervention
timeFrame: Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final survey at week 12
measure: Changes in life satisfaction over the course of the exercise intervention
timeFrame: Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final survey at week 12
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.
timeFrame: Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final survey at week 12
measure: Changes in general affect over the course of the exercise intervention
timeFrame: Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final survey at week 12
measure: Changes in leisure time physical activity over the course of the exercise intervention
timeFrame: Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final survey at week 12
measure: Changes in physical health symptomology over the course of the exercise intervention
timeFrame: Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final survey at week 12
measure: Changes in alcohol habits over the course of the exercise intervention
timeFrame: Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final survey at week 12
measure: Tracking the amount of exercise variety participants feel they engage in
timeFrame: Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final survey at week 12
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
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