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Well-Being (Psychological Flourishing)SCOPENCT04412343

The Seniors COvid-19 Pandemic and Exercise Study

A study testing Virtual Group Intervention and Personal Exercise Intervention in people with Well-Being (Psychological Flourishing) and Depression, 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 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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
What is being tested?
Virtual Group Intervention and Personal Exercise Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
241 participants
Where
1 siteCanada
Study dates
23 May 2020to 5 Oct 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 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University of British Columbia

    Vancouver, British Columbia, V6T 1Z1

Other trials in Canada

About this study

Official title: 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.

Being tested
Virtual Group Intervention, Personal Exercise Intervention
Medical subject headings
Depression, Motor Activity, Social Identification

What participants receive

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

  • Virtual Group InterventionBehavioural

    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 InterventionBehavioural

    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.

Study groups in NCT04412343
Study groupRoleWhat they receive
Virtual group exerciseExperimentalIndividuals 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.
Receives: Behavioral: Virtual Group Intervention
Personal exerciseExperimentalEach 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.
Receives: Behavioral: Personal Exercise Intervention
Wait-list controlNo interventionThose 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 being measured

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

  1. Well-Being (Psychological Flourishing)

    Well-being will be self reported using an 8-item measure from Diener et al., 2010

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

Secondary outcomes (13)

  1. Life Satisfaction

    1-item question by Fleeson, 2004

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

  2. Stress

    1 Item Statistics Canada Stress Question from the Canadian Community Health Survey (2012)

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

  3. Depression

    10 Item Center for Epidemiologic Studies Depression Scale (CES-D) via Andresen et al., 1994

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

  4. Resilience

    6 item Brief Resilience Scale by Smith et al., 2008

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

  5. Social Identification

    items adapted from the 4-item scale by Doosje et al., 1995

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

  6. Social and Emotional Lonliness

    11-item scale by De Jong Gierveld et al., 2006

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

  7. Chronic Illness (Physical Health)

    question by Charles et al., 2006 adapted from Larsen et al., 1991

    Measured: Baseline (Week 0)

  8. Weekly Somatic Symptoms (Physical Health)

    question by Charles et al., 2006 adapted from Marmot et al., 1997

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

  9. 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).

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

  10. Alcohol Habits

    3-item measure for alcohol consumption from CDC Behavioral Risk Factor Surveillance System Survey Questionnaire, 1984-2019

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

  11. Physical Adherence

    Objective measure of attendance in online sessions (interventions conditions only)

    Measured: Looked at each day of the week for 12 weeks to see if a session was attended

  12. Affective Attitudes

    3 semantic differential items toward physical activity using scale by Azjen, 2006

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

  13. 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).

    Measured: Baseline only (Week 0)

Timeline

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

  1. First posted2 Jun 2020
  2. Study start23 May 2020
  3. Primary completion5 Oct 2020
  4. Study completion5 Oct 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
Single blind
Who is masked
Outcomes assessor
Enrolment
241 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04412343
Sponsor's protocol ID
H20-01515
Acronym
SCOPE
Status last verified
Nov 2020
First submitted
29 May 2020
Last updated
3 Nov 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.).

Publications

  • 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.

  • 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

  • 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

  • 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

  • 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.

  • 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.

    PubMed 1960638

  • 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.

    PubMed 9080570

  • 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.

    PubMed 15673042

  • 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.

    PubMed 4053261

  • 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.

  • 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.

    PubMed 34328433

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Group Intervention and Personal Exercise Intervention in people with Well-Being (Psychological Flourishing) and Depression, 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 7 inclusion and 8 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 3 Nov 2020. 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?

Well-Being (Psychological Flourishing) (time frame: Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Follow-up (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 NCT04412343, which also lists 15 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 3 Nov 2020.

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