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Improving Activity Engagement Among Persons With SCI During COVID-19

Primary Purpose

Spinal Cord Injuries

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
WebEx Physical Activity Program
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring spinal cord injury, spinal cord injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adult 18 years or older; living with a spinal cord injury; living in the community in Ontario; access to a computer and internet

Exclusion Criteria:

  • Not cleared by a physician to participate

Sites / Locations

  • St. Josephs Parkwood InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

The program will be delivered twice-weekly through 45-minute sessions over 6 weeks. An experienced fitness instructor with lived experience and a graduate student from the Department of Health and Rehabilitation Sciences, will lead a class of 4-6 participants. The sessions will be comprised of a 10-minute warm-up phase, a 25-minute aerobic phase and a 10-minute cool-down phase that will incorporate upper-extremity flexibility exercises and mindfulness meditation. Over the duration the instructor will be sensitive to varying levels of function and fitness and will structure the classes to enable a slow progression of intensity. Individual semi-structured interviews will be completed over the WebEx platform to garner feedback and improve study programming for future implementation of a health care service at Parkwood Institute Outpatient Clinic.

Outcomes

Primary Outcome Measures

Treatment Satisfaction
Treatment Satisfaction Questionnaire

Secondary Outcome Measures

Ability to Participate in Social Roles and Activities
Spinal Cord Injury - Quality of Life Short Form
Fatigue
Spinal Cord Injury - Quality of Life Short Form
Satisfaction with Social Roles and Activities
Spinal Cord Injury - Quality of Life Short Form
Positive Affect and Well-Being
Spinal Cord Injury - Quality of Life Short Form
Pain Interference
Spinal Cord Injury - Quality of Life Short Form
Resilience
Spinal Cord Injury - Quality of Life Short Form
Self-Esteem
Spinal Cord Injury - Quality of Life Short Form

Full Information

First Posted
May 20, 2020
Last Updated
May 17, 2022
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04408287
Brief Title
Improving Activity Engagement Among Persons With SCI During COVID-19
Official Title
Improving Activity Engagement Among Persons With SCI During COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
December 28, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
During the current COVID-19 pandemic many spinal cord injury (SCI) rehabilitation services are limited to emergency management, leaving those living in the community without access to services. Unfortunately, this can lead to negative effects including increase in emotional distress, feelings of isolation, and decreased activity engagement. Due to their limited mobility and greater likelihood of respiratory illness it is imperative to provide alternative forms of activity engagement to reduce their risk for secondary complications. Physical activity has been demonstrate to have numerous benefits for individuals with SCI ranging from enhanced health through prevention of secondary complications to improved subjective well-being. The current study proposes to provide an online physical activity program through web-based videoconferencing to person with SCI to improve overall wellbeing and activity engagement. The program will consist of six weeks of twice-weekly, 45-minute sessions in which an experienced fitness instructor (i.e., wheelchair aerobics) with lived experience and a Kinesiology graduate student will lead online sessions. The sessions will be comprised of a 10-minute warm-up phase, a 25-minute aerobic phase and a 10-minute cool-down phase that will incorporate upper-extremity flexibility exercises and guided meditation. In all cases, remote (i.e., in-home) participant monitoring of physiological signals will be conducted by the instructor to ensure safety of participants. Once the program has been completed, participants will be asked to complete self-report questionnaires related to acceptability, feasibility, and limited effectiveness. Participants will also be asked to complete a brief semi-structured interview examining barriers and facilitators of the program. Participant feedback from the interviews will be used to further develop of the program to meet the needs of the population and develop sustainable approaches for access to care in the community setting through collaborations with community partners (SCI Ontario, National SCI Alliance, Ontario Neurotrauma Foundation). Ultimately, the proposed project aims to improve overall wellbeing and access to health care service for those with SCI during the COVID-19 quarantine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
spinal cord injury, spinal cord injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The proposed study will deliver an online physical activity program to persons with SCI across Ontario through the WebEx platform at Parkwood Institute. Participants will be recruited from across Ontario through SCI rehabilitation centers and established service providers. Strategic advertising through community partners such as Spinal Cord Injury Ontario, Canadian SCI Alliance and Ontario Neurotrauma Foundation will also be conducted. Study participants will include those with a spinal cord injury that have completed rehabilitation and are living in the community. Participants must have some upper limb function permitting arm movement against gravity. All participants must have physician clearance to participate in the study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
The program will be delivered twice-weekly through 45-minute sessions over 6 weeks. An experienced fitness instructor with lived experience and a graduate student from the Department of Health and Rehabilitation Sciences, will lead a class of 4-6 participants. The sessions will be comprised of a 10-minute warm-up phase, a 25-minute aerobic phase and a 10-minute cool-down phase that will incorporate upper-extremity flexibility exercises and mindfulness meditation. Over the duration the instructor will be sensitive to varying levels of function and fitness and will structure the classes to enable a slow progression of intensity. Individual semi-structured interviews will be completed over the WebEx platform to garner feedback and improve study programming for future implementation of a health care service at Parkwood Institute Outpatient Clinic.
Intervention Type
Other
Intervention Name(s)
WebEx Physical Activity Program
Intervention Description
The program will be delivered twice-weekly through 45-minute sessions over 6 weeks. An experienced fitness instructor with lived experience and a graduate student from the Department of Health and Rehabilitation Sciences, will lead a class of 4-6 participants. The sessions will be comprised of a 10-minute warm-up phase, a 25-minute aerobic phase and a 10-minute cool-down phase that will incorporate upper-extremity flexibility exercises and mindfulness meditation. Over the duration the instructor will be sensitive to varying levels of function and fitness and will structure the classes to enable a slow progression of intensity. Individual semi-structured interviews will be completed over the WebEx platform to garner feedback and improve study programming for future implementation of a health care service at Parkwood Institute Outpatient Clinic.
Primary Outcome Measure Information:
Title
Treatment Satisfaction
Description
Treatment Satisfaction Questionnaire
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Ability to Participate in Social Roles and Activities
Description
Spinal Cord Injury - Quality of Life Short Form
Time Frame
Baseline, 6 weeks, and at 3 month follow-up
Title
Fatigue
Description
Spinal Cord Injury - Quality of Life Short Form
Time Frame
Baseline, 6 weeks, and at 3 month follow-up
Title
Satisfaction with Social Roles and Activities
Description
Spinal Cord Injury - Quality of Life Short Form
Time Frame
Baseline, 6 weeks, and at 3 month follow-up
Title
Positive Affect and Well-Being
Description
Spinal Cord Injury - Quality of Life Short Form
Time Frame
Baseline, 6 weeks, and at 3 month follow-up
Title
Pain Interference
Description
Spinal Cord Injury - Quality of Life Short Form
Time Frame
Baseline, 6 weeks, and at 3 month follow-up
Title
Resilience
Description
Spinal Cord Injury - Quality of Life Short Form
Time Frame
Baseline, 6 weeks, and at 3 month follow-up
Title
Self-Esteem
Description
Spinal Cord Injury - Quality of Life Short Form
Time Frame
Baseline, 6 weeks, and at 3 month follow-up
Other Pre-specified Outcome Measures:
Title
Fear of COVID-19 Scale
Description
Fear of COVID-19 Scale
Time Frame
Baseline, 6 weeks, and at 3 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult 18 years or older; living with a spinal cord injury; living in the community in Ontario; access to a computer and internet Exclusion Criteria: Not cleared by a physician to participate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Swati Mehta, PhD
Phone
5196466100
Ext
42359
Email
swati.mehta@sjhc.london.on.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Daymon D Blackport
Email
daymon.blackport@sjhc.london.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Swati Mehta, PhD
Organizational Affiliation
Lawson Health Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eldon Loh, PhD
Organizational Affiliation
Parkwood Institute, St. Joseph's Health Care London
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Josephs Parkwood Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 5J1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Swati Mehta, PhD
Phone
519-646-6100
Ext
42359
Email
swati.mehta@sjhc.london.on.ca
First Name & Middle Initial & Last Name & Degree
Daymon D Blackport
Email
daymon.blackport@sjhc.on.ca
First Name & Middle Initial & Last Name & Degree
Swati Mehta, PhD
First Name & Middle Initial & Last Name & Degree
Eldon Loh, PhD
First Name & Middle Initial & Last Name & Degree
Dalton Wolfe, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Improving Activity Engagement Among Persons With SCI During COVID-19

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