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

Primary Purpose

Well-Being (Psychological Flourishing), Depression, Quality of Life

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Virtual Group Intervention

Personal Exercise Intervention

About this trial

This is an interventional prevention trial for Well-Being (Psychological Flourishing)

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of British Columbia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Virtual group exercise

Personal exercise

Wait-list control

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Well-Being (Psychological Flourishing)

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

Secondary Outcome Measures

Life Satisfaction

1-item question by Fleeson, 2004

Stress

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

Depression

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

Resilience

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

Social Identification

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

Social and Emotional Lonliness

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

Chronic Illness (Physical Health)

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

Weekly Somatic Symptoms (Physical Health)

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

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).

Alcohol Habits

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

Physical Adherence

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

Affective Attitudes

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

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).

Full Information

NCT ID

NCT04412343

First Posted

May 29, 2020

Last Updated

November 2, 2020

Sponsor

University of British Columbia

Collaborators

University of Victoria

1. Study Identification

Unique Protocol Identification Number

NCT04412343

Brief Title

The Seniors COvid-19 Pandemic and Exercise Study

Acronym

SCOPE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

May 23, 2020 (Actual)

Primary Completion Date

October 5, 2020 (Actual)

Study Completion Date

October 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of British Columbia

Collaborators

University of Victoria

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

241 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Virtual group exercise

Arm Type

Experimental

Arm Description

Arm Title

Personal exercise

Arm Type

Experimental

Arm Description

Arm Title

Wait-list control

Arm Type

No Intervention

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Virtual Group Intervention

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Personal Exercise Intervention

Intervention Description

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.

Primary Outcome Measure Information:

Title

Well-Being (Psychological Flourishing)

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Life Satisfaction

Description

1-item question by Fleeson, 2004

Time Frame

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

Title

Stress

Description

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

Time Frame

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

Title

Depression

Description

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

Time Frame

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

Title

Resilience

Description

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

Time Frame

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

Title

Social Identification

Description

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

Time Frame

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

Title

Social and Emotional Lonliness

Description

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

Time Frame

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

Title

Chronic Illness (Physical Health)

Description

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

Time Frame

Baseline (Week 0)

Title

Weekly Somatic Symptoms (Physical Health)

Description

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

Time Frame

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

Title

Leisure-time physical activity

Description

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).

Time Frame

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

Title

Alcohol Habits

Description

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

Time Frame

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

Title

Physical Adherence

Description

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

Time Frame

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

Title

Affective Attitudes

Description

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

Time Frame

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

Title

Demographics

Description

Time Frame

Baseline only (Week 0)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark R Beauchamp, PhD

Organizational Affiliation

University of British Columbia

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of British Columbia

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6T 1Z1

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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 URL

https://osf.io/xw9gm

Citations:

Citation

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.

Results Reference

background

PubMed Identifier

8037935

Citation

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.

Results Reference

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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.

Results Reference

background

Citation

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

Results Reference

background

Citation

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.

Results Reference

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Citation

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

Results Reference

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PubMed Identifier

18696313

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.

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Citation

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.

Results Reference

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PubMed Identifier

1960638

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. doi: 10.1111/j.1467-6494.1991.tb00254.x.

Results Reference

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PubMed Identifier

9080570

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. doi: 10.1016/s0277-9536(96)00194-3.

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PubMed Identifier

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Citation

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.

Results Reference

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PubMed Identifier

4053261

Citation

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.

Results Reference

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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.

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Citation

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

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PubMed Identifier

34328433

Citation

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.

Results Reference

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The Seniors COvid-19 Pandemic and Exercise Study

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