Clinical trial NCT06040749: Virtual Sport for Adults ≥ 50 Years With Spinal Cord Injury
Official title: Peer-facilitated Virtual Sport for Adults ≥ 50 Years With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Keywords: Virtual sport
Sport
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2023-09-18
Enrollment: 5
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Sport is a physical activity that has many physical, psychological and social benefits for those with spinal cord injury (SCI). However, most sport research involves people with SCI who are \<50 years old. This is a problem because many people are \>50 years old when first injured. Moreover, people with a SCI are now living longer lives, meaning they also experience more health challenges. Unfortunately, there is limited research studying the impact of sport for adults with SCI aged ≥50 years old.

Detailed description: Aim: To investigate the impact of sport for people with SCI who are ≥50 years old.

Sport Program: This program will be a trial of virtual handcycling. Fifteen male and five female volunteers who are ≥50 years old, ≥12 months post-SCI, wheelchair users, and medically cleared to exercise will be recruited. Five participants will complete the program at a time, as a group, on Microsoft Teams. The sport program will begin with a physiotherapist virtually leading 15 minutes of warm-up exercises. Next, a person living with SCI who is aged ≥50 years old will facilitate 45 minutes of virtual handcycling while screen sharing an indoor cycling application called Zwift, which will provide participants with visual cues and context for changes in exercise intensity. Participants will be provided a cycle ergometer so they can participate in their own homes, and with a smart watch so heart rate can be monitored. This program will run twice a week for three months.

Outcomes: Data will be collected on physical, psychological, and social health at (1) the start of the sport program, (2) immediately after, and (3) three months after the program ends. Any adverse events experienced will be recorded on a survey. Participants' feedback on the sport program and confidence in staying active will also be assessed using an interview at the end.

Conclusion: The knowledge gained will assist in creating future sport programs that may help address the challenges associated with aging and SCI.

Eligibility criteria: Inclusion Criteria:

1. Sustained a traumatic or non-progressive, non-traumatic SCI,
2. Chronic stage of recovery (i.e., ≥12 months post-SCI),
3. ≥50 years old,
4. Be a manual wheelchair user,
5. Able to understand spoken English,
6. Can attend two virtual handcycling sessions/week for 12 weeks and attend on-site assessments,
7. Does not intend to change usual physical activity routine throughout duration of the intervention,
8. Be cleared to participate in exercise (determined through completion of the 2022 Physical Activity Readiness Questionnaire for Everyone (PAR-Q+)58),
9. Able to secure hands on handlebars with or without assistance during at-home sessions,
10. Has one emergency contact who can be promptly reached at any point during the intervention,
11. Can independently perform easy-moderate revolutions of arm ergometry movement for ≥10 minutes, with or without adaptations to secure the hands on the handlebars, and
12. Can independently bring up at least one hand to wave at shoulder level.

Exclusion Criteria:

1. Present with significant shoulder pain that reduces use of upper limbs,
2. Present with condition(s) other than SCI that affect ability to use upper limbs or follow English instructions,
3. Have a pressure injury (\>grade 2) on the pelvis, sacrum, or hand(s), or
4. Experienced major trauma or surgery within the last 6 months
5. Have a history of cardiovascular disease (myocardial infarction, stroke, hyperlipidemia or untreated hypertension) and do not receive physician clearance to participate.

Primary outcomes:
measure: Spinal Cord Independence Measure
timeFrame: Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention
measure: Positive Affect and Well-Being Scale of the Quality of Life in Neurological Disorders Measure (PAWB-Neuro-QoL)
timeFrame: Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention
measure: Multidimensional Scale of Perceived Social Support
timeFrame: Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention
measure: Moorong Self-Efficacy Scale
timeFrame: Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention
measure: Spinal Cord Injury Exercise Self-Efficacy Scale
timeFrame: Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention
measure: 6 Minute Push Test
timeFrame: Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention
measure: Semi-structured Interview
timeFrame: Within 12 weeks after the intervention
Secondary outcomes:
measure: Adverse Events
timeFrame: During the 12-week intervention
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: KITE-Toronto Rehabilitation Institute, UHN
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Kristin E Musselman, PhD
role: PRINCIPAL_INVESTIGATOR
References: