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

November 2, 2020 updated by: Mark Beauchamp, University of British Columbia

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
241

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 1Z1
        • University of British Columbia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Well-Being (Psychological Flourishing)
Time Frame: 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
Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Follow-up (Week 12)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Life Satisfaction
Time Frame: Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Follow-up (Week 12)
1-item question by Fleeson, 2004
Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Follow-up (Week 12)
Stress
Time Frame: 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)
Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Follow-up (Week 12)
Depression
Time Frame: 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
Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Follow-up (Week 12)
Resilience
Time Frame: 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
Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Follow-up (Week 12)
Social Identification
Time Frame: 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
Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Follow-up (Week 12)
Social and Emotional Lonliness
Time Frame: 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
Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Follow-up (Week 12)
Chronic Illness (Physical Health)
Time Frame: Baseline (Week 0)
question by Charles et al., 2006 adapted from Larsen et al., 1991
Baseline (Week 0)
Weekly Somatic Symptoms (Physical Health)
Time Frame: 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
Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Follow-up (Week 12)
Leisure-time physical activity
Time Frame: 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).
Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Follow-up (Week 12)
Alcohol Habits
Time Frame: 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
Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Follow-up (Week 12)
Physical Adherence
Time Frame: 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)
Looked at each day of the week for 12 weeks to see if a session was attended
Affective Attitudes
Time Frame: 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
Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Follow-up (Week 12)
Demographics
Time Frame: 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).
Baseline only (Week 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of British Columbia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Victoria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 23, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 5, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 5, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 2, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 3, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H20-01515

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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 Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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