Virtual Sport for Adults ≥ 50 Years With Spinal Cord Injury

April 3, 2025 updated by: Kristin Musselman, University Health Network, Toronto

Peer-facilitated 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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Toronto, Ontario, Canada
        • KITE-Toronto Rehabilitation Institute, UHN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual group-based handcycling
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.
Virtual group-based handcycling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention
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.
Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention
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.
Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention
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.
Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention
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.
Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention
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.
Within 12 weeks after the intervention
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.
Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During the 12-week intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kristin E Musselman, PhD, University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2023

Primary Completion (Actual)

September 30, 2024

Study Completion (Actual)

September 30, 2024

Study Registration Dates

First Submitted

May 29, 2023

First Submitted That Met QC Criteria

September 12, 2023

First Posted (Actual)

September 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 6, 2025

Last Update Submitted That Met QC Criteria

April 3, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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