Spinal Cord InjuriesNCT04408287
Improving Activity Engagement Among Persons With SCI During COVID-19
A study testing WebEx Physical Activity Program in people with Spinal Cord Injuries, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
During the current COVID-19 pandemic many spinal cord injury (SCI) rehabilitation services are limited to emergency management, leaving those living in the community without access to services. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- WebEx Physical Activity Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 15 Sep 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult 18 years or older; living with a spinal cord injury; living in the community in Ontario; access to a computer and internet
Who cannot join
- Not cleared by a physician to participate
Trial locations and contacts
1 site in 1 country.
About this study
During the current COVID-19 pandemic many spinal cord injury (SCI) rehabilitation services are limited to emergency management, leaving those living in the community without access to services. Unfortunately, this can lead to negative effects including increase in emotional distress, feelings of isolation, and decreased activity engagement. Due to their limited mobility and greater likelihood of respiratory illness it is imperative to provide alternative forms of activity engagement to reduce their risk for secondary complications. Physical activity has been demonstrate to have numerous benefits for individuals with SCI ranging from enhanced health through prevention of secondary complications to improved subjective well-being. The current study proposes to provide an online physical activity program through web-based videoconferencing to person with SCI to improve overall wellbeing and activity engagement. The program will consist of six weeks of twice-weekly, 45-minute sessions in which an experienced fitness instructor (i.e., wheelchair aerobics) with lived experience and a Kinesiology graduate student will lead online sessions. The sessions will be comprised of a 10-minute warm-up phase, a 25-minute aerobic phase and a 10-minute cool-down phase that will incorporate upper-extremity flexibility exercises and guided meditation. In all cases, remote (i.e., in-home) participant monitoring of physiological signals will be conducted by the instructor to ensure safety of participants. Once the program has been completed, participants will be asked to complete self-report questionnaires related to acceptability, feasibility, and limited effectiveness. Participants will also be asked to complete a brief semi-structured interview examining barriers and facilitators of the program. Participant feedback from the interviews will be used to further develop of the program to meet the needs of the population and develop sustainable approaches for access to care in the community setting through collaborations with community partners (SCI Ontario, National SCI Alliance, Ontario Neurotrauma Foundation). Ultimately, the proposed project aims to improve overall wellbeing and access to health care service for those with SCI during the COVID-19 quarantine.
- Conditions
- Spinal Cord Injuries
- Being tested
- WebEx Physical Activity Program
- Keywords
- spinal cord injury, spinal cord injuries
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WebEx Physical Activity ProgramOther
The program will be delivered twice-weekly through 45-minute sessions over 6 weeks. An experienced fitness instructor with lived experience and a graduate student from the Department of Health and Rehabilitation Sciences, will lead a class of 4-6 participants. The sessions will be comprised of a 10-minute warm-up phase, a 25-minute aerobic phase and a 10-minute cool-down phase that will incorporate upper-extremity flexibility exercises and mindfulness meditation. Over the duration the instructor will be sensitive to varying levels of function and fitness and will structure the classes to enable a slow progression of intensity. Individual semi-structured interviews will be completed over the WebEx platform to garner feedback and improve study programming for future implementation of a health care service at Parkwood Institute Outpatient Clinic.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The program will be delivered twice-weekly through 45-minute sessions over 6 weeks. An experienced fitness instructor with lived experience and a graduate student from the Department of Health and Rehabilitation Sciences, will lead a class of 4-6 participants. The sessions will be comprised of a 10-minute warm-up phase, a 25-minute aerobic phase and a 10-minute cool-down phase that will incorporate upper-extremity flexibility exercises and mindfulness meditation. Over the duration the instructor will be sensitive to varying levels of function and fitness and will structure the classes to enable a slow progression of intensity. Individual semi-structured interviews will be completed over the WebEx platform to garner feedback and improve study programming for future implementation of a health care service at Parkwood Institute Outpatient Clinic. Receives: Other: WebEx Physical Activity Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Satisfaction
Treatment Satisfaction Questionnaire
Measured: 6 weeks
Secondary outcomes (7)
Ability to Participate in Social Roles and Activities
Spinal Cord Injury - Quality of Life Short Form
Measured: Baseline, 6 weeks, and at 3 month follow-up
Fatigue
Spinal Cord Injury - Quality of Life Short Form
Measured: Baseline, 6 weeks, and at 3 month follow-up
Satisfaction with Social Roles and Activities
Spinal Cord Injury - Quality of Life Short Form
Measured: Baseline, 6 weeks, and at 3 month follow-up
Positive Affect and Well-Being
Spinal Cord Injury - Quality of Life Short Form
Measured: Baseline, 6 weeks, and at 3 month follow-up
Pain Interference
Spinal Cord Injury - Quality of Life Short Form
Measured: Baseline, 6 weeks, and at 3 month follow-up
Resilience
Spinal Cord Injury - Quality of Life Short Form
Measured: Baseline, 6 weeks, and at 3 month follow-up
Self-Esteem
Spinal Cord Injury - Quality of Life Short Form
Measured: Baseline, 6 weeks, and at 3 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start15 Sep 2020
- Primary completion28 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The proposed study will deliver an online physical activity program to persons with SCI across Ontario through the WebEx platform at Parkwood Institute. Participants will be recruited from across Ontario through SCI rehabilitation centers and established service providers. Strategic advertising through community partners such as Spinal Cord Injury Ontario, Canadian SCI Alliance and Ontario Neurotrauma Foundation will also be conducted. Study participants will include those with a spinal cord injury that have completed rehabilitation and are living in the community. Participants must have some upper limb function permitting arm movement against gravity. All participants must have physician clearance to participate in the study.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Swati Mehta, PhD, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sEldon Loh, PhD, Principal investigator, Parkwood Institute, St. Joseph's Health Care London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04408287
- Sponsor's protocol ID
- 115929
- Status last verified
- Mar 2024
- First submitted
- 20 May 2020
- Last updated
- 15 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Activity Engagement Among Persons With SCI During COVID-19
- ClinicalTrials.gov ID
- NCT04408287
- Acronym / sponsor ID
- 115929
- Conditions
- Spinal Cord Injuries
- Keywords
- spinal cord injury, spinal cord injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 28 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 29 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
During the current COVID-19 pandemic many spinal cord injury (SCI) rehabilitation services are limited to emergency management, leaving those living in the community without access to services. Unfortunately, this can lead to negative effects including increase in emotional distress, feelings of isolation, and decreased activity engagement. Due to their limited mobility and greater likelihood of respiratory illness it is imperative to provide alternative forms of activity engagement to reduce their risk for secondary complications. Physical activity has been demonstrate to have numerous benefits for individuals with SCI ranging from enhanced health through prevention of secondary complications to improved subjective well-being. The current study proposes to provide an online physical activity program through web-based videoconferencing to person with SCI to improve overall wellbeing and activity engagement. The program will consist of six weeks of twice-weekly, 45-minute sessions in which an experienced fitness instructor (i.e., wheelchair aerobics) with lived experience and a Kinesiology graduate student will lead online sessions. The sessions will be comprised of a 10-minute warm-up phase, a 25-minute aerobic phase and a 10-minute cool-down phase that will incorporate upper-extremity flexibility exercises and guided meditation. In all cases, remote (i.e., in-home) participant monitoring of physiological signals will be conducted by the instructor to ensure safety of participants. Once the program has been completed, participants will be asked to complete self-report questionnaires related to acceptability, feasibility, and limited effectiveness. Participants will also be asked to complete a brief semi-structured interview examining barriers and facilitators of the program. Participant feedback from the interviews will be used to further develop of the program to meet the needs of the population and develop sustainable approaches for access to care in the community setting through collaborations with community partners (SCI Ontario, National SCI Alliance, Ontario Neurotrauma Foundation). Ultimately, the proposed project aims to improve overall wellbeing and access to health care service for those with SCI during the COVID-19 quarantine.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The proposed study will deliver an online physical activity program to persons with SCI across Ontario through the WebEx platform at Parkwood Institute. Participants will be recruited from across Ontario through SCI rehabilitation centers and established service providers. Strategic advertising through community partners such as Spinal Cord Injury Ontario, Canadian SCI Alliance and Ontario Neurotrauma Foundation will also be conducted. Study participants will include those with a spinal cord injury that have completed rehabilitation and are living in the community. Participants must have some upper limb function permitting arm movement against gravity. All participants must have physician clearance to participate in the study.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: WebEx Physical Activity ProgramThe program will be delivered twice-weekly through 45-minute sessions over 6 weeks. An experienced fitness instructor with lived experience and a graduate student from the Department of Health and Rehabilitation Sciences, will lead a class of 4-6 participants. The sessions will be comprised of a 10-minute warm-up phase, a 25-minute aerobic phase and a 10-minute cool-down phase that will incorporate upper-extremity flexibility exercises and mindfulness meditation. Over the duration the instructor will be sensitive to varying levels of function and fitness and will structure the classes to enable a slow progression of intensity. Individual semi-structured interviews will be completed over the WebEx platform to garner feedback and improve study programming for future implementation of a health care service at Parkwood Institute Outpatient Clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult 18 years or older; living with a spinal cord injury; living in the community in Ontario; access to a computer and internet
Key exclusion criteria (1 listed)
- Not cleared by a physician to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WebEx Physical Activity ProgramThe program will be delivered twice-weekly through 45-minute sessions over 6 weeks. An experienced fitness instructor with lived experience and a graduate student from the Department of Health and Rehabilitation Sciences, will lead a class of 4-6 participants. The sessions will be comprised of a 10-minute warm-up phase, a 25-minute aerobic phase and a 10-minute cool-down phase that will incorporate upper-extremity flexibility exercises and mindfulness meditation. Over the duration the instructor will be sensitive to varying levels of function and fitness and will structure the classes to enable a slow progression of intensity. Individual semi-structured interviews will be completed over the WebEx platform to garner feedback and improve study programming for future implementation of a health care service at Parkwood Institute Outpatient Clinic. | Other | Intervention |
Primary outcome
Treatment Satisfaction
Time frame: 6 weeks
Treatment Satisfaction Questionnaire
7 secondary outcomes
Ability to Participate in Social Roles and Activities
Time frame: Baseline, 6 weeks, and at 3 month follow-up
Fatigue
Time frame: Baseline, 6 weeks, and at 3 month follow-up
Satisfaction with Social Roles and Activities
Time frame: Baseline, 6 weeks, and at 3 month follow-up
Positive Affect and Well-Being
Time frame: Baseline, 6 weeks, and at 3 month follow-up
Pain Interference
Time frame: Baseline, 6 weeks, and at 3 month follow-up
Resilience
Time frame: Baseline, 6 weeks, and at 3 month follow-up
Self-Esteem
Time frame: Baseline, 6 weeks, and at 3 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Swati Mehta, PhD principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Eldon Loh, PhD principal investigator
Parkwood Institute, St. Joseph's Health Care London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WebEx Physical Activity Program in people with Spinal Cord Injuries, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Satisfaction (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.