Improving Activity Engagement Among Persons With SCI During COVID-19

Spinal Cord Injuries Clinical Trial

Official title:

Improving Activity Engagement Among Persons With SCI During COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04408287
• Other study ID #: 115929
• Status: Completed
• Phase: N/A
• Start date: September 15, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2024
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 31, 2022
• Est. primary completion date: December 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

Other:
• WebEx Physical Activity Program
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.

Locations

Country	Name	City	State
Canada	St. Josephs Parkwood Institute	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fear of COVID-19 Scale	Fear of COVID-19 Scale	Baseline, 6 weeks, and at 3 month follow-up
Primary	Treatment Satisfaction	Treatment Satisfaction Questionnaire	6 weeks
Secondary	Ability to Participate in Social Roles and Activities	Spinal Cord Injury - Quality of Life Short Form	Baseline, 6 weeks, and at 3 month follow-up
Secondary	Fatigue	Spinal Cord Injury - Quality of Life Short Form	Baseline, 6 weeks, and at 3 month follow-up
Secondary	Satisfaction with Social Roles and Activities	Spinal Cord Injury - Quality of Life Short Form	Baseline, 6 weeks, and at 3 month follow-up
Secondary	Positive Affect and Well-Being	Spinal Cord Injury - Quality of Life Short Form	Baseline, 6 weeks, and at 3 month follow-up
Secondary	Pain Interference	Spinal Cord Injury - Quality of Life Short Form	Baseline, 6 weeks, and at 3 month follow-up
Secondary	Resilience	Spinal Cord Injury - Quality of Life Short Form	Baseline, 6 weeks, and at 3 month follow-up
Secondary	Self-Esteem	Spinal Cord Injury - Quality of Life Short Form	Baseline, 6 weeks, and at 3 month follow-up