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Completed

NCT Number: NCT06040749

Virtual Sport for Adults ≥ 50 Years With Spinal Cord Injury

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KITE-Toronto Rehabilitation Institute, UHN

Toronto, Ontario, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Virtual group-based handcycling

Other

Virtual group-based handcycling

Primary outcomes

  1. Spinal Cord Independence Measure

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

    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.

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

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

    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.

  3. Multidimensional Scale of Perceived Social Support

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

    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.

  4. Moorong Self-Efficacy Scale

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

    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.

  5. Spinal Cord Injury Exercise Self-Efficacy Scale

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

    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.

  6. 6 Minute Push Test

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

    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.

  7. Semi-structured Interview

    Time frame: Within 12 weeks after the intervention

    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.

Secondary outcomes

  1. Adverse Events

    Time frame: During the 12-week intervention

    Adverse events will be monitored throughout the 12-week intervention. Participants will be asked to complete a survey either online or on paper within 24 hours of experiencing an adverse event. The survey will consist of questions including type, location, and severity. The survey will consist of both closed- and open-ended questions about the circumstances surrounding the adverse event.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

Peer-facilitated Virtual Sport for Adults ≥ 50 Years With Spinal Cord Injury

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 18, 2023
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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