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Depressive SymptomatologyCOPENCT04400279

The COVID-19 Pandemic and Exercise Study

A study testing Yoga group, High Intensity Interval Training group and Combination in people with Depressive Symptomatology and Psychological Distress, run by University of British Columbia at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 64 yearsHealthy volunteers can take part
What is being tested?
Yoga group, High Intensity Interval Training group and Combination
Could I receive a placebo?
No, everyone receives an active treatment
How many people
334 participants
Where
1 siteCanada
Study dates
1 Jun 2020to 28 Nov 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University of British Columbia

    Vancouver, British Columbia, V6T1Z4

Other trials in Canada

About this 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

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.

Read the 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.

Being tested
Yoga group, High Intensity Interval Training group, Combination
Keywords
exercise, intervention, resilience, depression, general affect, flourishing, psychological distress
Medical subject headings
Health Behavior, Motor Activity, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Yoga groupBehavioural

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

  • High Intensity Interval Training groupBehavioural

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

  • CombinationBehavioural

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

Study groups in NCT04400279
Study groupRoleWhat they receive
Yoga Exercise groupExperimentalUsing 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.
Receives: Behavioral: Yoga group
High Intensity Interval Training groupExperimentalUsing 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.
Receives: Behavioral: High Intensity Interval Training group
Combination Yoga & HIIT groupExperimentalUsing 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.
Receives: Behavioral: Combination
Control groupNo interventionThis 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 being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

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

  8. 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.

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

  9. 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.

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

  10. 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.

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

  11. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2020
  2. Study start1 Jun 2020
  3. Primary completion28 Nov 2020
  4. Study completion28 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
334 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04400279
Sponsor's protocol ID
H20-01497
Acronym
COPE
Status last verified
Jan 2021
First submitted
21 May 2020
Last updated
11 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Holmes EA, O'Connor RC, Perry VH, Tracey I, Wessely S, Arseneault L, Ballard C, Christensen H, Cohen Silver R, Everall I, Ford T, John A, Kabir T, King K, Madan I, Michie S, Przybylski AK, Shafran R, Sweeney A, Worthman CM, Yardley L, Cowan K, Cope C, Hotopf M, Bullmore E. Multidisciplinary research priorities for the COVID-19 pandemic: a call for action for mental health science. Lancet Psychiatry. 2020 Jun;7(6):547-560. doi: 10.1016/S2215-0366(20)30168-1. Epub 2020 Apr 15.

    PubMed 32304649

  • Pedersen BK, Saltin B. Exercise as medicine - evidence for prescribing exercise as therapy in 26 different chronic diseases. Scand J Med Sci Sports. 2015 Dec;25 Suppl 3:1-72. doi: 10.1111/sms.12581.

    PubMed 26606383

  • 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.

    PubMed 28088704

  • 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.

    PubMed 26978184

  • 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.

    PubMed 32421163

  • 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.

    PubMed 36042918

  • 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.

    PubMed 30953508

  • 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.

    PubMed 23539308

  • 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.

    PubMed 25771785

  • 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.

    PubMed 26402859

  • Andresen EM, Malmgren JA, Carter WB, Patrick DL. Screening for depression in well older adults: evaluation of a short form of the CES-D (Center for Epidemiologic Studies Depression Scale). Am J Prev Med. 1994 Mar-Apr;10(2):77-84.

    PubMed 8037935

  • Statistics (2012), Canada Canadian Community Health Survey. Share File, Knowledge Management and Reporting Branch, Ontario MOHLTC

  • Kessler RC, Andrews G, Colpe LJ, Hiripi E, Mroczek DK, Normand SL, Walters EE, Zaslavsky AM. Short screening scales to monitor population prevalences and trends in non-specific psychological distress. Psychol Med. 2002 Aug;32(6):959-76. doi: 10.1017/s0033291702006074.

    PubMed 12214795

  • Diener, E., Wirtz, D., Tov, W., Kim-Prieto, C., Choi, D. W., Oishi, S., & Biswas-Diener, R. (2010). New well-being measures: Short scales to assess flourishing and positive and negative feelings. Social indicators research, 97(2), 143-156.

  • Smith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J. The brief resilience scale: assessing the ability to bounce back. Int J Behav Med. 2008;15(3):194-200. doi: 10.1080/10705500802222972.

    PubMed 18696313

Questions about this trial

What is this clinical trial studying?

A study testing Yoga group, High Intensity Interval Training group and Combination in people with Depressive Symptomatology and Psychological Distress, run by University of British Columbia at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04400279, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2021.

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