- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04408287
Improving Activity Engagement Among Persons With SCI During COVID-19
March 14, 2024 updated by: Lawson Health Research Institute
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- 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 Contact
- Name: Swati Mehta, PhD
- Phone Number: 42359 5196466100
- Email: swati.mehta@sjhc.london.on.ca
Study Contact Backup
- Name: Daymon D Blackport
- Email: daymon.blackport@sjhc.london.on.ca
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6C 5J1
- St. Josephs Parkwood Institute
-
-
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
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
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: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment Satisfaction
Time Frame: 6 weeks
|
Treatment Satisfaction Questionnaire
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ability to Participate in Social Roles and Activities
Time Frame: Baseline, 6 weeks, and at 3 month follow-up
|
Spinal Cord Injury - Quality of Life Short Form
|
Baseline, 6 weeks, and at 3 month follow-up
|
Fatigue
Time Frame: Baseline, 6 weeks, and at 3 month follow-up
|
Spinal Cord Injury - Quality of Life Short Form
|
Baseline, 6 weeks, and at 3 month follow-up
|
Satisfaction with Social Roles and Activities
Time Frame: Baseline, 6 weeks, and at 3 month follow-up
|
Spinal Cord Injury - Quality of Life Short Form
|
Baseline, 6 weeks, and at 3 month follow-up
|
Positive Affect and Well-Being
Time Frame: Baseline, 6 weeks, and at 3 month follow-up
|
Spinal Cord Injury - Quality of Life Short Form
|
Baseline, 6 weeks, and at 3 month follow-up
|
Pain Interference
Time Frame: Baseline, 6 weeks, and at 3 month follow-up
|
Spinal Cord Injury - Quality of Life Short Form
|
Baseline, 6 weeks, and at 3 month follow-up
|
Resilience
Time Frame: Baseline, 6 weeks, and at 3 month follow-up
|
Spinal Cord Injury - Quality of Life Short Form
|
Baseline, 6 weeks, and at 3 month follow-up
|
Self-Esteem
Time Frame: Baseline, 6 weeks, and at 3 month follow-up
|
Spinal Cord Injury - Quality of Life Short Form
|
Baseline, 6 weeks, and at 3 month follow-up
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fear of COVID-19 Scale
Time Frame: Baseline, 6 weeks, and at 3 month follow-up
|
Fear of COVID-19 Scale
|
Baseline, 6 weeks, and at 3 month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Eldon Loh, PhD, Parkwood Institute, St. Joseph's Health Care London
- Principal Investigator: Swati Mehta, PhD, Lawson Health Research Institute
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)
September 15, 2020
Primary Completion (Actual)
December 28, 2022
Study Completion (Actual)
December 31, 2022
Study Registration Dates
First Submitted
May 20, 2020
First Submitted That Met QC Criteria
May 28, 2020
First Posted (Actual)
May 29, 2020
Study Record Updates
Last Update Posted (Actual)
March 15, 2024
Last Update Submitted That Met QC Criteria
March 14, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 115929
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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