Spinal Cord InjuriesWOWiiNCT05353842
Scale Up of Project Workout on Wheels Internet Intervention (WOWii)
A study testing WOWii Program in people with Spinal Cord Injuries, run by Craig Hospital at 2 sites in United States.
Trial summary
This study is designed is to test the feasibility, fidelity, and effectiveness of scaling up an evidence- and theory-based virtually delivered physical activity intervention (WOWii) for individuals living with chronic SCI for delivery through other rehabilitation settings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- WOWii Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Jan 2022to 30 Sep 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- more than 12 months post SCI
- requires use of wheelchair due to SCI
- receive signed approval from medical provider to initiate moderate-intensity exercise program
- have internet access via computer, tablet, or smartphone
- provide informed consent
Who cannot join
- already engaged in engaged in sufficient physical activity to meet CDCP guidelines
- cognitive of language impairments that would affect ability to participate
- presence of medical issue for which exercise is contraindicated
- pregnancy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Shepherd Center
Atlanta, Georgia, 30309
Kessler Foundation
West Orange, New Jersey, 07052
About this study
Official title: Scale Up Trial of Project WOWii to Increase Exercise Among People With Spinal Cord Injury (SCI)
This study is designed is to test the feasibility, fidelity, and effectiveness of scaling up an evidence- and theory-based virtually delivered physical activity intervention (WOWii) for individuals living with chronic SCI for delivery through other rehabilitation settings. The study outcomes address (1) feasibility based on participant enrollment, retention, and program engagement; (2) fidelity of intervention delivery; and (3) program effectiveness based on subjective and objective exercise data, and participant exercise perceptions regarding self-efficacy and barriers.
- Conditions
- Spinal Cord Injuries
- Being tested
- WOWii Program
- 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.
WOWii ProgramBehavioural
Workout on Wheels Internet Internvention (WOWii) which includes: 1) WOWii website to guide participants in an exercise program, 2) home exercise starter program; 3) weekly support from a peer facilitator via online (video) meetings.
| Study group | Role | What they receive |
|---|---|---|
| WOWii Intervention | Experimental | Workout on Wheels Internet Intervention (WOWii) program which includes: 1) WOWii website to guide participants in an exercise program, 2) home exercise starter program; 3) weekly support from a peer facilitator via online (video) meetings. Receives: Behavioral: WOWii Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment of Participants in WOWii Program (feasibility)
Total number of participants enrolled at each site
Measured: One time at end of study recruitment
Retention of Participants Enrolled in WOWii Program (feasibility)
Total number of WOWii sessions attended
Measured: One time at end of 16 week intervention
Engagement of Participants Enrolled in WOWii Program (feasibilty)
Total number of WOWii online activities completed
Measured: One time at end of 16 week intervention
Percentage of behavior skills covered by peer facilitators during WOWii Program (fidelity)
Percentage of items on fidelity check list that are marked as completed
Measured: One time at end of 16 week intervention
% of WOWii sessions in which peer facilitators generate group-based conversation (fidelity)
% of sessions on fidelity check list that are marked as having grop-based conversation
Measured: One time at end of 16 week intervention
Change in number of minutes spent in aerobic exercise (effectiveness)
Objective measure of change in activity level
Measured: Baseline, end of intervention (Week 16), end of follow up (Week 24)
Change in score on International Physical Activity Questionnaire Scores (effectiveness)
8-item survey asking days/week and minutes/day spent in various physical activities.
Measured: Baseline, end of intervention (Week 16), end of follow up (Week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start2 Jan 2022
- Primary completion29 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Craig Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kessler Institute for Rehabilitation, Shepherd Center, Atlanta GA
- Responsible party
- Principal investigator, Katherine Froehlich-Grobe, Craig Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05353842
- Sponsor's protocol ID
- 901FRE0046-01-01
- Acronym
- WOWii
- Status last verified
- Apr 2024
- First submitted
- 3 Jan 2022
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- 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 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scale Up Trial of Project WOWii to Increase Exercise Among People With Spinal Cord Injury (SCI)
- ClinicalTrials.gov ID
- NCT05353842
- Acronym / sponsor ID
- WOWii / 901FRE0046-01-01
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Craig HospitalUniversity, hospital or other
- Collaborators
- Kessler Institute for Rehabilitation, Shepherd Center, Atlanta GA
- Study start
- 2 Jan 2022 (actual)
- Primary completion
- 29 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 29 Apr 2022 (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.
This study is designed is to test the feasibility, fidelity, and effectiveness of scaling up an evidence- and theory-based virtually delivered physical activity intervention (WOWii) for individuals living with chronic SCI for delivery through other rehabilitation settings. The study outcomes address (1) feasibility based on participant enrollment, retention, and program engagement; (2) fidelity of intervention delivery; and (3) program effectiveness based on subjective and objective exercise data, and participant exercise perceptions regarding self-efficacy and barriers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WOWii Intervention | Experimental | Behavioral: WOWii ProgramWorkout on Wheels Internet Intervention (WOWii) program which includes: 1) WOWii website to guide participants in an exercise program, 2) home exercise starter program; 3) weekly support from a peer facilitator via online (video) meetings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- more than 12 months post SCI
- requires use of wheelchair due to SCI
- receive signed approval from medical provider to initiate moderate-intensity exercise program
- have internet access via computer, tablet, or smartphone
- provide informed consent
Key exclusion criteria (4 listed)
- already engaged in engaged in sufficient physical activity to meet CDCP guidelines
- cognitive of language impairments that would affect ability to participate
- presence of medical issue for which exercise is contraindicated
- pregnancy
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 |
|---|---|---|
| WOWii ProgramWorkout on Wheels Internet Internvention (WOWii) which includes: 1) WOWii website to guide participants in an exercise program, 2) home exercise starter program; 3) weekly support from a peer facilitator via online (video) meetings. | Behavioural | WOWii Intervention |
Primary outcome
Enrollment of Participants in WOWii Program (feasibility)
Time frame: One time at end of study recruitment
Total number of participants enrolled at each site
Retention of Participants Enrolled in WOWii Program (feasibility)
Time frame: One time at end of 16 week intervention
Total number of WOWii sessions attended
Engagement of Participants Enrolled in WOWii Program (feasibilty)
Time frame: One time at end of 16 week intervention
Total number of WOWii online activities completed
Percentage of behavior skills covered by peer facilitators during WOWii Program (fidelity)
Time frame: One time at end of 16 week intervention
Percentage of items on fidelity check list that are marked as completed
% of WOWii sessions in which peer facilitators generate group-based conversation (fidelity)
Time frame: One time at end of 16 week intervention
% of sessions on fidelity check list that are marked as having grop-based conversation
Change in number of minutes spent in aerobic exercise (effectiveness)
Time frame: Baseline, end of intervention (Week 16), end of follow up (Week 24)
Objective measure of change in activity level
Change in score on International Physical Activity Questionnaire Scores (effectiveness)
Time frame: Baseline, end of intervention (Week 16), end of follow up (Week 24)
8-item survey asking days/week and minutes/day spent in various physical activities.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WOWii Program in people with Spinal Cord Injuries, run by Craig Hospital at 2 sites in United States.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Results are not available in the source record.
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?
Enrollment of Participants in WOWii Program (feasibility) (time frame: One time at end of study recruitment). The study lists 7 primary outcomes in all. 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 30 Apr 2024.