Virtual Sport for Adults ≥ 50 Years With Spinal Cord Injury

NCT06040749 | Completed

• 1 other identifier: 23-5096
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Keywords

Virtual sport; Sport

Outcome Measures

Primary Outcomes (7)

• Spinal Cord Independence Measure

  A questionnaire that evaluates the functional abilities of individuals with spinal cord injury (SCI). This scale consists of three sub-scales that assess areas of function most relevant to SCI: self-care (scored from 0-20), respiration and sphincter management (scored from 0-40), and mobility (scored from 0-40). Final scores for the Spinal Cord Independence Measure (SCIM) range from 0-100, where a higher score indicates greater functional ability.

  Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention

• Positive Affect and Well-Being Scale of the Quality of Life in Neurological Disorders Measure (PAWB-Neuro-QoL)

  A questionnaire that assesses affect and sense of well-being. Each statement is to be rated from 1 to 5 ("never" to "always"). The minimum score is 9 and the maximum score is 45. A higher score reflects a greater sense of well-being.

  Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention

• Multidimensional Scale of Perceived Social Support

  A questionnaire that evaluates perceived help from a significant other, family, and friends. Each statement is to be rated from 1 to 7 ("very strongly disagree" to "very strongly agree"). The minimum score is 12 and the maximum score is 84. A higher score reflects greater perceived social support.

  Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention

• Moorong Self-Efficacy Scale

  A questionnaire that assesses confidence in performing everyday activities. Each item is scored on a 7-point scale, for a total score out of 112, with a higher score indicating greater self-efficacy.

  Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention

• Spinal Cord Injury Exercise Self-Efficacy Scale

  A questionnaire that assesses an individual's confidence in performing various physical activities and exercise. Each statement is scored on a 4-point Likert scale, for a total score out of 40, in which a higher score indicates greater perceived exercise self-efficacy.

  Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention

• 6 Minute Push Test

  A field-based assessment that assesses aerobic fitness in manual wheelchair users. During this test, participants will be instructed to propel their wheelchair for 6 minutes along a 30 meter loop while an assessor records the total distanced travelled.

  Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention

• Semi-structured Interview

  This interview will explore participants' perspectives on a) whether the intervention affected their physical, psychological, and social health, and b) the delivery of the intervention itself (e.g., components, frequency, duration). A semi-structured interview guide informed by the Modified Health through Sport Conceptual Model will be used as a guide.

  Within 12 weeks after the intervention

Secondary Outcomes (1)

• Adverse Events

  During the 12-week intervention

Study Arms (1)

Virtual group-based handcycling

EXPERIMENTAL

Virtual group-based handcycling, twice per week for 12 weeks. Each 60-minute session of the intervention will begin with maximum 15 minutes of physiotherapist-led warm-up exercises. Next, a peer-facilitated handcycling session, lasting maximum 45 minutes, will proceed. The handcycling component involves the upper extremities cycling in tandem on a stationary exercise bike. The peer facilitator will be an individual with SCI aged \>50 years, who will co-lead participants alongside the physiotherapist through brief group discussion, maximum 40 minutes of moderate-vigorous handcycling, and maximum 5 minutes of cool-down.

Other: Virtual group-based handcycling

Interventions

Virtual group-based handcycling OTHER

Virtual group-based handcycling

Virtual group-based handcycling

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

KITE-Toronto Rehabilitation Institute, UHN

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Kristin E Musselman, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 29, 2023
• First Posted: September 18, 2023
• Study Start: May 5, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: April 6, 2025

Record last verified: 2024-11

Locations

CA (1)