The COVID-19 Pandemic and Exercise Study

NCT ID: NCT04400279

Last Updated: 2021-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

334 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2020-11-28

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.

Conditions

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Depressive Symptomatology Psychological Distress Health Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
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.

Study Groups

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Yoga Exercise group

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.

Group Type EXPERIMENTAL

Yoga group

Intervention Type BEHAVIORAL

At-home yoga exercise instruction provided by a mobile/tablet app or through a computer web browser

High Intensity Interval Training group

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.

Group Type EXPERIMENTAL

High Intensity Interval Training group

Intervention Type BEHAVIORAL

At-home HIIT exercise instruction provided by a mobile/tablet app or through a computer web browser

Combination Yoga & HIIT group

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.

Group Type EXPERIMENTAL

Combination

Intervention Type BEHAVIORAL

At-home yoga \& HIIT exercise instruction provided by a mobile/tablet app or through a computer web browser

Control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Yoga group

At-home yoga exercise instruction provided by a mobile/tablet app or through a computer web browser

Intervention Type BEHAVIORAL

High Intensity Interval Training group

At-home HIIT exercise instruction provided by a mobile/tablet app or through a computer web browser

Intervention Type BEHAVIORAL

Combination

At-home yoga \& HIIT exercise instruction provided by a mobile/tablet app or through a computer web browser

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Eli Puterman

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of British Columbia

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

References

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Reference Type DERIVED
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Other Identifiers

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H20-01497

Identifier Type: -

Identifier Source: org_study_id

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