The Seniors COvid-19 Pandemic and Exercise Study (SCOPE)

The Seniors COvid-19 Pandemic and Exercise Study: A Randomized Controlled Trial

The purpose of this study is to evaluate different types of exercise programs (virtual group-based exercise program; personal exercise program; wait-list control) across 12-weeks on the physical and mental health of older adults during the current Covid-19 pandemic.

Study Overview

• Status: Completed
• Conditions: Depression; Quality of Life; Physical Activity; Loneliness; Social Identification; Physical Health; Well-Being (Psychological Flourishing)
• Intervention / Treatment: Behavioral: Virtual Group Intervention; Behavioral: Personal Exercise Intervention

• Study Type: Interventional
• Enrollment (Actual): 241
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6T 1Z1
      • University of British Columbia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 65+ years old
• be able to speak and read English
• one participant in the study per household (Spouses, significant others, or family members can take part in the exercise programs with the study participant; however, they will not be able to provide data and won't be remunerated for participating)
• not experience any contraindication which might prevent that person from participating in moderate-intensity physical activity.
• participants must be able to access the internet at home via a personal smartphone, tablet (e.g., ipad), or computer (device used must have camera capabilities)
• low active individuals (i.e., less than 150 minutes of moderate-to-vigorous physical activity per week)
• currently living in Canada

Exclusion Criteria:

• age of less than 65 years
• unable to read and speak in English
• inability to participate in moderate-to-vigorous physical activity (including a lack of ability to receive doctor's clearance for participating in physical activity)
• lack of internet access which does not allow them to access online materials
• device used to access the internet does not have a camera/video capabilities
• active individuals (e.g., participate in greater than 150 minutes of moderate-to-vigorous physical activity each week)
• living outside Canada
• not the first person from a household to enroll in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual group exercise; Individuals in the (virtual) group-based exercise program, will have the opportunity to take part in (virtual) group exercise classes, delivered via videoconferencing, by experienced older adult exercise instructors. Personnel who analyze the data collected from the study are not aware of the treatment applied to any given group. Classes will be offered multiple days a week at 9am PST (12 noon EST), and will last approximately 50 minutes. Classes include a warm-up component, moderate intensity exercises as the core component of the class, and a cool-down. At the end of classes participants will have the opportunity to connect in small groups (videoconferencing breakout groups) to socially connect over a beverage (coffee, water) from their own homes. Participants in the group condition will also be sent, by mail, a program t-shirt to foster a sense of distinctiveness.	Behavioral: Virtual Group Intervention; Participants will receive weekly exercise courses delivered virtually to a group of older adults. This intervention will last for 12 weeks. Participants in addition to participating in exercise will have designated time after each exercise class to socially connect. Participants in this condition will also receive a t-shirt.
Experimental: Personal exercise; Each of the older adult instructors described above will also contribute to delivering pre-recorded exercise classes (involving the same exercises, intensity, music, and so forth as those described above for the group condition). However, in this instance, instructors will deliver those classes to each participant by referring to themselves as each participant's personal trainer/coach, with language directed to the individual and not the group. That is, no sense of 'groupness' or 'shared social identities/connectivity' will be primed. Also, participants in this condition will not have the opportunity to interact with other older adults after classes have ended and will not receive the same program t-shirts designed to foster a sense of group distinctiveness.	Behavioral: Personal Exercise Intervention; Participants will receive weekly exercise courses delivered virtually. These classes will be pre-recorded so the individual can complete sessions at any time that is convenient for them.
No Intervention: Wait-list control; Those randomized to the wait-list control condition will go about their daily lives for the duration of the 12-week trial. They will be asked to complete the same questionnaires (and will be remunerated in the same way as those in the other two conditions via $10 per questionnaire completion). At the end of the 12-week trial, participants in this condition will have access to the personal exercise programming.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Well-Being (Psychological Flourishing)	Well-being will be self reported using an 8-item measure from Diener et al., 2010	Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Follow-up (Week 12)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Life Satisfaction	1-item question by Fleeson, 2004	Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Follow-up (Week 12)
Stress	1 Item Statistics Canada Stress Question from the Canadian Community Health Survey (2012)	Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Follow-up (Week 12)
Depression	10 Item Center for Epidemiologic Studies Depression Scale (CES-D) via Andresen et al., 1994	Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Follow-up (Week 12)
Resilience	6 item Brief Resilience Scale by Smith et al., 2008	Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Follow-up (Week 12)
Social Identification	items adapted from the 4-item scale by Doosje et al., 1995	Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Follow-up (Week 12)
Social and Emotional Lonliness	11-item scale by De Jong Gierveld et al., 2006	Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Follow-up (Week 12)
Chronic Illness (Physical Health)	question by Charles et al., 2006 adapted from Larsen et al., 1991	Baseline (Week 0)
Weekly Somatic Symptoms (Physical Health)	question by Charles et al., 2006 adapted from Marmot et al., 1997	Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Follow-up (Week 12)
Leisure-time physical activity	modified version of the Leisure Score Index (LSI; Courneya, Jones, Rhodes, & Blanchard, 2004) that has been applied to Godin's Leisure Time Exercise Questionnaire (GLTEQ; Godin & Shepard, 1985).	Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Follow-up (Week 12)
Alcohol Habits	3-item measure for alcohol consumption from CDC Behavioral Risk Factor Surveillance System Survey Questionnaire, 1984-2019	Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Follow-up (Week 12)
Physical Adherence	Objective measure of attendance in online sessions (interventions conditions only)	Looked at each day of the week for 12 weeks to see if a session was attended
Affective Attitudes	3 semantic differential items toward physical activity using scale by Azjen, 2006	Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Follow-up (Week 12)
Demographics	Items addressing sex/gender, age, ethnicity, sexual orientation, chronic conditions, smoking behaviour, height, weight, education level, household income level, employment status, marital status, and living situation (i.e., alone vs. others).	Baseline only (Week 0)

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: University of Victoria

Publications and helpful links

General Publications

• 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.
• Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.
• 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.
• 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.
• Courneya KS, Jones LW, Rhodes RE, Blanchard CM. Effects of different combinations of intensity categories on self-reported exercise. Res Q Exerc Sport. 2004 Dec;75(4):429-33. doi: 10.1080/02701367.2004.10609176. No abstract available.
• Centers for Disease Control and Prevention (CDC). (1984 - 2019). Behavioral Risk Factor Surveillance System Survey Questionnaire. Atlanta, Georgia: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention.
• Doosje, B., Ellemers, N., Spears, R. (1995) Perceived intragroup variability as a function of group status and identification. Journal of Experimental Social Psychology 31(5): 410-436.
• De Jong Gierveld, J, Tilburg, TV. A 6-Item Scale for Overall, Emotional, and Social Loneliness: Confirmatory Tests on Survey Data. Research on Aging. 2006; 28(5): 582-598.
• Charles, S.T. & Almeida, D.M. Daily reports of symptoms and negative affect: Not all symptoms are the same. Psychology & Health. 2006; 21(1): 1-17
• Fleeson, W. (2004). The quality of American life at the end of the century. In O. G. Brim, C. D. Ryff, & R. C. Kessler (Eds.), How healthy are we? A national study of wellbeing at midlife. Chicago: University of Chicago Press.
• Statistics Canada (2012), Canada Canadian Community Health Survey. Share File, Knowledge Management and Reporting Branch, Ontario MOHLTC
• Larsen RJ, Kasimatis M. Day-to-day physical symptoms: individual differences in the occurrence, duration, and emotional concomitants of minor daily illnesses. J Pers. 1991 Sep;59(3):387-423. doi: 10.1111/j.1467-6494.1991.tb00254.x.
• Marmot M, Ryff CD, Bumpass LL, Shipley M, Marks NF. Social inequalities in health: next questions and converging evidence. Soc Sci Med. 1997 Mar;44(6):901-10. doi: 10.1016/s0277-9536(96)00194-3.
• Ajzen, I. (2006). Constructing a TPB questionnaire: Conceptual and methodological considerations. Retrieved from https://pdfs.semanticscholar.org/0574/b20bd58130dd5a961f1a2db10fd1fcbae95d.pdf
• Beauchamp MR, Hulteen RM, Ruissen GR, Liu Y, Rhodes RE, Wierts CM, Waldhauser KJ, Harden SH, Puterman E. Online-Delivered Group and Personal Exercise Programs to Support Low Active Older Adults' Mental Health During the COVID-19 Pandemic: Randomized Controlled Trial. J Med Internet Res. 2021 Jul 30;23(7):e30709. doi: 10.2196/30709.

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2020
• Primary Completion (Actual): October 5, 2020
• Study Completion (Actual): October 5, 2020

Study Registration Dates

• First Submitted: May 29, 2020
• First Submitted That Met QC Criteria: May 29, 2020
• First Posted (Actual): June 2, 2020

Study Record Updates

• Last Update Posted (Actual): November 3, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: H20-01515

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The protocol for this study will be available on Open Science Framework (after 4 months to allow for study completion). The Statistical Analysis Plan will also be available on Open Science Framework. The Consent form is freely available if requested from the Primary Investigator (PI: Beauchamp, M.).
• IPD Sharing Time Frame: Data will be available from this trial 1 year after completion of the study. The data will remain available indefinitely.
• IPD Sharing Access Criteria: The nature of the request for sharing access will be reviewed by the PI (Beauchamp, M) and the data management team. Data will be shared via secure platforms (Redcap). Contact for data access can be done through personal communications (e.g., email) with PI Beauchamp.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No