Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
288 participants
INTERVENTIONAL
2022-03-31
2022-12-16
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The COVID-19 Pandemic and Exercise Study
NCT04400279
COVID-19, Chronic Adaptation and Response to Exercise (COVID-CARE)
NCT04595773
Effects of Exercise Training on Patients With Long COVID-19
NCT05961462
The Seniors COvid-19 Pandemic and Exercise Study
NCT04412343
Impact of Exercise Intervention on Well-being in Shift-working Acute Care Nurses
NCT05966805
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
To investigators knowledge, there are no studies that have used a mobile application promoting exercise to reduce the depressive symptomatology, psychological distress, and physical symptoms among HCWs in a hospital or home setting. Dr. Puterman's COVID-19 Pandemic and Exercise (COPE) trial (https://www.copetrial.ca/) is the first to study the impact of a mhealth-delivered program designed for physically distanced adults at the start of the pandemic. Results indicate significant treatment effects between those randomized to the active groups (who experienced a reduction in depressive symptoms over the 6-week period) compared to waitlist control (who remained elevated in depressive symptoms). Importantly, these effects were even more apparent in the adults with pre-randomization high levels of depression. Also, the group that was given access to both the HIIT and yoga apps had the highest adherence rates for trial completion (58%) compared to those who received access to either but not both apps (53% or 40% for yoga and HIIT, respectively). Considering the above, the purpose of the present study is to evaluate the uptake and adherence of a 12-week mhealth physical activity (access to all the mobile "Down Dog" apps: HIIT, yoga, barre, running) intervention in physically less active HCWs, to examine whether the intervention leads to improvement in depressive symptomatology among those randomized to the intervention versus waitlist control group. Specifically, investigators aim to focus on physical activities requiring little physical space and/or equipment that are easily completed at home, in one's neighbourhood, or in a small office using the suite of mobile apps from the company "Down Dog".
The purpose of the present study is to evaluate the uptake and adherence of a 12-week mhealth physical activity (access to all the mobile "Down Dog" apps: HIIT, yoga, barre, running) intervention in physically less active HCWs, to examine whether the intervention leads to improvement in depressive symptomatology among those randomized to the intervention versus waitlist control group. Specifically, investigators aim to focus on physical activities requiring little physical space and/or equipment that are easily completed at home, in one's neighbourhood, or in a small office using the suite of mobile apps from the company "Down Dog".
The primary objectives of this project are to test a mhealth physical activity intervention, using the "Down Dog" suite of apps, in physically less active HCWs, and to test whether the intervention leads to improvement in depressive symptomatology among those who are randomized to the intervention compared to the waitlist control group. The secondary objectives of this project are to test the intervention effects on a broader suite of mental health concepts, including stress, flourishing, resilience, life satisfaction, burnout, work-family spillover, sleep quality, and absenteeism. Thirdly, investigators seek to identify barriers and facilitators to increasing levels of physical activity during the intervention, from the perspective of stakeholders such as nurses, health service administrators, and physicians, and to determine the efficacy of the intervention, using qualitative interviews and focus group discussions.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
Using Optimal Design Software, to detect a small effect size δ= .30 based on a two-level (non)linear growth model (six time points; level-1 residual variability = 8.798; level-1 coefficient variability = 22.548) with Power (1 - b) = .80 and alpha = .05 for 7 time points repeated measures design, 357 participants required across the four arms. With an additional 10 recruitment sites, investigators require an additional 90 participants (for the possibility of nesting or for creation of 9 dummy variables to covary locations). With a 20% expected attrition, a total of 560 HCWs will be randomized. Investigators will be employing this conservative target for this study.
In order to detect a small effect size δ= .40 and a 20% expected attrition, a total of 366 HCWs will be randomized.
In order to detect a small effect size δ= .50 and a 20% expected attrition, a total of 276 HCWs will be randomized.
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Exercise group
Weeks 1 - 12:
* For the duration of the study, participant will be completing any of the physical activities customizable within the Down Dog apps. He/she will be asked to complete a minimum of four 20-minute workouts per week.
* Every two weeks, participant will receive a survey to complete.
Week 24:
* At week 24 (12 weeks after their initial 12-week participation in the study), participant will receive a check-in email with the final survey to complete.
* Investigators will also record the use of the apps at week 24.
Exercise
The mHealth platform to be used by the exercise group is Down Dog, which has a suite of apps for yoga, HIIT, barre, and running workouts. Down Dog has agreed to provide free memberships for one year to all participants in the study. To ensure participant de-identification on the Down Dog platform, each participant will receive a Participant ID which will be pre-registered by the study coordinator on the Down Dog platform. Randomized participants will be provided instructions for downloading the apps onto their phone or a link to the website to be used on their computer. Following randomization, participants in the exercise group will be asked to engage in physical activity (using any if the Down Dog apps), 4 days a week for 20 minutes a day for 12 weeks.
Waitlist control group
Weeks 1 - 12:
* For the 12 weeks of the study, participant will be asked to continue their typical, pre-study daily and weekly routine, maintaining the physical activity he/she was completing before the start of the study.
* Every two weeks, the participant will receive a survey to complete.
Week 24:
• At the end of the first 12 weeks that he/she have access to the suite of apps (i.e., 24 weeks following their randomization to the waitlist control group), participant will receive a check-in email with the final survey to complete.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Exercise
The mHealth platform to be used by the exercise group is Down Dog, which has a suite of apps for yoga, HIIT, barre, and running workouts. Down Dog has agreed to provide free memberships for one year to all participants in the study. To ensure participant de-identification on the Down Dog platform, each participant will receive a Participant ID which will be pre-registered by the study coordinator on the Down Dog platform. Randomized participants will be provided instructions for downloading the apps onto their phone or a link to the website to be used on their computer. Following randomization, participants in the exercise group will be asked to engage in physical activity (using any if the Down Dog apps), 4 days a week for 20 minutes a day for 12 weeks.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* To screen for the low active participants, investigators will use the L-CAT (see Section 9.5). All participants who score 1-3 will be included in the study. Those who score 4-6 will be excluded.
* They must also work at a Providence Health Care centre.
Exclusion Criteria
* In addition, as informed consent requires individuals to be at least 18 years old, participants under the age of 18 will be excluded.
* Participants who are currently retired from their work or who do not currently work at a PHC centre are ineligible to participate.
* Participants without personal smartphones or computers, and those without internet service at home will be excluded.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Providence Health & Services
OTHER
University of British Columbia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Eli Puterman
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Eli Puterman, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of British Columbia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of British Columbia
Vancouver, British Columbia, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Embriaco N, Papazian L, Kentish-Barnes N, Pochard F, Azoulay E. Burnout syndrome among critical care healthcare workers. Curr Opin Crit Care. 2007 Oct;13(5):482-8. doi: 10.1097/MCC.0b013e3282efd28a.
Martin M. Physician Well-Being: Physician Burnout. FP Essent. 2018 Aug;471:11-15.
Marjanovic Z, Greenglass ER, Coffey S. The relevance of psychosocial variables and working conditions in predicting nurses' coping strategies during the SARS crisis: an online questionnaire survey. Int J Nurs Stud. 2007 Aug;44(6):991-8. doi: 10.1016/j.ijnurstu.2006.02.012. Epub 2006 Apr 17.
Lai J, Ma S, Wang Y, Cai Z, Hu J, Wei N, Wu J, Du H, Chen T, Li R, Tan H, Kang L, Yao L, Huang M, Wang H, Wang G, Liu Z, Hu S. Factors Associated With Mental Health Outcomes Among Health Care Workers Exposed to Coronavirus Disease 2019. JAMA Netw Open. 2020 Mar 2;3(3):e203976. doi: 10.1001/jamanetworkopen.2020.3976.
Wu PE, Styra R, Gold WL. Mitigating the psychological effects of COVID-19 on health care workers. CMAJ. 2020 Apr 27;192(17):E459-E460. doi: 10.1503/cmaj.200519. Epub 2020 Apr 15. No abstract available.
Pospos S, Young IT, Downs N, Iglewicz A, Depp C, Chen JY, Newton I, Lee K, Light GA, Zisook S. Web-Based Tools and Mobile Applications To Mitigate Burnout, Depression, and Suicidality Among Healthcare Students and Professionals: a Systematic Review. Acad Psychiatry. 2018 Feb;42(1):109-120. doi: 10.1007/s40596-017-0868-0. Epub 2017 Dec 18.
Rathbone AL, Prescott J. The Use of Mobile Apps and SMS Messaging as Physical and Mental Health Interventions: Systematic Review. J Med Internet Res. 2017 Aug 24;19(8):e295. doi: 10.2196/jmir.7740.
Puterman E, Hives B, Mazara N, Grishin N, Webster J, Hutton S, Koehle MS, Liu Y, Beauchamp MR. COVID-19 Pandemic and Exercise (COPE) trial: a multigroup pragmatic randomised controlled trial examining effects of app-based at-home exercise programs on depressive symptoms. Br J Sports Med. 2022 May;56(10):546-552. doi: 10.1136/bjsports-2021-104379. Epub 2021 Sep 27.
Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
Cho E, Chen TY. The effects of work-family experiences on health among older workers. Psychol Aging. 2018 Nov;33(7):993-1006. doi: 10.1037/pag0000293. Epub 2018 Oct 11.
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.
Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.
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.
Boucher VG, Haight BL, Hives BA, Zumbo BD, Merali-Dewji A, Hutton S, Liu Y, Nguyen S, Beauchamp MR, Black AT, Puterman E. Effects of 12 Weeks of At-Home, Application-Based Exercise on Health Care Workers' Depressive Symptoms, Burnout, and Absenteeism: A Randomized Clinical Trial. JAMA Psychiatry. 2023 Nov 1;80(11):1101-1109. doi: 10.1001/jamapsychiatry.2023.2706.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H21-02612
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.