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Virtual Sport for Adults ≥ 50 Years With Spinal Cord Injury

Primary Purpose

Spinal Cord Injury

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Virtual group-based handcycling
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Spinal Cord Injury focused on measuring Virtual sport, Sport

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • KITE-Toronto Rehabilitation Institute, UHNRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Virtual group-based handcycling

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Adverse Events
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.

Full Information

First Posted
May 29, 2023
Last Updated
September 15, 2023
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT06040749
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2023 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
Virtual sport, Sport

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual group-based handcycling
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Virtual group-based handcycling
Intervention Description
Virtual group-based handcycling
Primary Outcome Measure Information:
Title
Spinal Cord Independence Measure
Description
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.
Time Frame
Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention
Title
Positive Affect and Well-Being Scale of the Quality of Life in Neurological Disorders Measure (PAWB-Neuro-QoL)
Description
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.
Time Frame
Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention
Title
Multidimensional Scale of Perceived Social Support
Description
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.
Time Frame
Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention
Title
Moorong Self-Efficacy Scale
Description
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.
Time Frame
Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention
Title
Spinal Cord Injury Exercise Self-Efficacy Scale
Description
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.
Time Frame
Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention
Title
6 Minute Push Test
Description
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.
Time Frame
Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention
Title
Semi-structured Interview
Description
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.
Time Frame
Within 12 weeks after the intervention
Secondary Outcome Measure Information:
Title
Adverse Events
Description
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.
Time Frame
During the 12-week intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristin E Musselman, PhD
Phone
416-597-3422
Ext
6190
Email
kristin.musselman@uhn.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin E Musselman, PhD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
KITE-Toronto Rehabilitation Institute, UHN
City
Toronto
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristin Musselman, PhD
Phone
(416) 597-3422
Ext
6190
Email
kristin.musselman@uhn.ca

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Virtual Sport for Adults ≥ 50 Years With Spinal Cord Injury

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