SCOPE: The Seniors COvid-19 Pandemic and Exercise Study

Sponsor
University of British Columbia (Other)
Overall Status
Completed
CT.gov ID
NCT04412343
Collaborator
University of Victoria (Other)
241
1
3
4.4
54.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Virtual Group Intervention
  • Behavioral: Personal Exercise Intervention
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
241 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (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.
Primary Purpose:
Prevention
Official Title:
The Seniors COvid-19 Pandemic and Exercise Study: A Randomized Controlled Trial
Actual Study Start Date :
May 23, 2020
Actual Primary Completion Date :
Oct 5, 2020
Actual Study Completion Date :
Oct 5, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Well-Being (Psychological Flourishing) [Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Follow-up (Week 12)]

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

Secondary Outcome Measures

  1. Life Satisfaction [Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Follow-up (Week 12)]

    1-item question by Fleeson, 2004

  2. Stress [Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Follow-up (Week 12)]

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

  3. Depression [Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Follow-up (Week 12)]

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

  4. Resilience [Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Follow-up (Week 12)]

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

  5. Social Identification [Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Follow-up (Week 12)]

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

  6. Social and Emotional Lonliness [Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Follow-up (Week 12)]

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

  7. Chronic Illness (Physical Health) [Baseline (Week 0)]

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

  8. Weekly Somatic Symptoms (Physical Health) [Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Follow-up (Week 12)]

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

  9. Leisure-time physical activity [Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Follow-up (Week 12)]

    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).

  10. Alcohol Habits [Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Follow-up (Week 12)]

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

  11. Physical Adherence [Looked at each day of the week for 12 weeks to see if a session was attended]

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

  12. Affective Attitudes [Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Follow-up (Week 12)]

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

  13. Demographics [Baseline only (Week 0)]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of British Columbia Vancouver British Columbia Canada V6T 1Z1

Sponsors and Collaborators

  • University of British Columbia
  • University of Victoria

Investigators

  • Principal Investigator: Mark R Beauchamp, PhD, University of British Columbia

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mark Beauchamp, Professor, University of British Columbia
ClinicalTrials.gov Identifier:
NCT04412343
Other Study ID Numbers:
  • H20-01515
First Posted:
Jun 2, 2020
Last Update Posted:
Nov 3, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 3, 2020