Clinical trial NCT04408287: 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
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: spinal cord injury
spinal cord injuries
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Treatment Satisfaction
timeFrame: 6 weeks
Secondary outcomes:
measure: Ability to Participate in Social Roles and Activities
timeFrame: Baseline, 6 weeks, and at 3 month follow-up
measure: Fatigue
timeFrame: Baseline, 6 weeks, and at 3 month follow-up
measure: Satisfaction with Social Roles and Activities
timeFrame: Baseline, 6 weeks, and at 3 month follow-up
measure: Positive Affect and Well-Being
timeFrame: Baseline, 6 weeks, and at 3 month follow-up
measure: Pain Interference
timeFrame: Baseline, 6 weeks, and at 3 month follow-up
measure: Resilience
timeFrame: Baseline, 6 weeks, and at 3 month follow-up
measure: Self-Esteem
timeFrame: Baseline, 6 weeks, and at 3 month follow-up
Other outcomes:
measure: Fear of COVID-19 Scale
timeFrame: Baseline, 6 weeks, and at 3 month follow-up
Locations:
city: London
country: Canada
facility: St. Josephs Parkwood Institute
state: Ontario
Study officials:
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Swati Mehta, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Parkwood Institute, St. Joseph's Health Care London
name: Eldon Loh, PhD
role: PRINCIPAL_INVESTIGATOR
References: