The COVID-19 Pandemic and Exercise Study

NCT04400279 | Completed

• 1 other identifier: H20-01497
• Study Type: interventional
• Target: 334
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Symptomatology; Psychological Distress; Health Behavior

Keywords

exercise; intervention; resilience; depression; general affect; flourishing; psychological distress

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Changes in psychological stress as measured by the SCSQ over the course of the exercise intervention.

  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.

  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

  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

  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

  Tracked weekly for 7 weeks (baseline, followed by 6 weeks of exercise intervention) and then a final survey at week 12

Study Arms (4)

Yoga Exercise group

EXPERIMENTAL

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

High Intensity Interval Training group

EXPERIMENTAL

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

Combination Yoga & HIIT group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Yoga group BEHAVIORAL

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

Yoga Exercise group

High Intensity Interval Training group BEHAVIORAL

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

High Intensity Interval Training group

Combination BEHAVIORAL

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

Combination Yoga & HIIT group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V6T1Z4, Canada

Location

Related Publications (25)

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  PMID: 34580067 DERIVED

MeSH Terms

Conditions

Health Behavior; Motor Activity; Depression

Condition Hierarchy (Ancestors)

Behavior; Behavioral Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: May 22, 2020
• Study Start: June 1, 2020
• Primary Completion: November 28, 2020
• Study Completion: November 28, 2020
• Last Updated: January 11, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 4 months following trial's end, materials will be made available. following publication, all data will be made available.
• 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

Locations

CA (1)