The Seniors COvid-19 Pandemic and Exercise Study

Depression Clinical Trial

— SCOPE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04412343
• Other study ID #: H20-01515
• Status: Completed
• Phase: N/A
• Start date: May 23, 2020
• Est. completion date: October 5, 2020

Study information

• Verified date: November 2020
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: October 5, 2020
• Est. primary completion date: October 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Loneliness
• Physical Activity
• Physical Health
• Quality of Life
• Social Identification
• Well-Being (Psychological Flourishing)

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	University of British Columbia	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	University of Victoria

Country where clinical trial is conducted

Canada, 

References & Publications (14)

Ajzen, I. (2006). Constructing a TPB questionnaire: Conceptual and methodological considerations. Retrieved from https://pdfs.semanticscholar.org/0574/b20bd58130dd5a961f1a2db10fd1fcbae95d.pdf

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. — View Citation

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.

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

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. — View Citation

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.

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.

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.

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Chronic Illness (Physical Health)	question by Charles et al., 2006 adapted from Larsen et al., 1991	Baseline (Week 0)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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)