The Seniors COvid-19 Pandemic and Exercise Study

NCT04412343 | Completed DMC

• 1 other identifier: H20-01515
• Study Type: interventional
• Target: 241
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Life Satisfaction

  Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Follow-up (Week 12)

• Stress

  Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Follow-up (Week 12)

• Depression

  Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Follow-up (Week 12)

• Resilience

  Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Follow-up (Week 12)

• Social Identification

  Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Follow-up (Week 12)

Study Arms (3)

Virtual group exercise

EXPERIMENTAL

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

Personal exercise

EXPERIMENTAL

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

Wait-list control

NO INTERVENTION

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.

Interventions

Virtual Group Intervention BEHAVIORAL

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.

Virtual group exercise

Personal Exercise Intervention BEHAVIORAL

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.

Personal exercise

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• + 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• University of Victoria: collaborator

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V6T 1Z1, Canada

Location

Related Publications (15)

• 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.

  BACKGROUND

• 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.

  PMID: 8037935 BACKGROUND

• 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.

  BACKGROUND

• 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

  BACKGROUND

• 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.

  BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 18696313 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 1960638 BACKGROUND

• 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.

  PMID: 9080570 BACKGROUND

• 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.

  PMID: 15673042 BACKGROUND

• 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.

  PMID: 4053261 BACKGROUND

• 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.

  BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 34328433 DERIVED

MeSH Terms

Conditions

Depression; Motor Activity; Social Identification

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Social Behavior

Study Officials

• Mark R Beauchamp, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: No experimenter or investigator expectancy effects as all assessment occurs online (i.e., online questionnaire). Personnel who analyze the data collected from the study are not aware of the treatment applied to any given group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 2, 2020
• Study Start: May 23, 2020
• Primary Completion: October 5, 2020
• Study Completion: October 5, 2020
• Last Updated: November 3, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available from this trial 1 year after completion of the study. The data will remain available indefinitely.
• 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.

Locations

CA (1)