Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Location status: Recruiting
NCT Number: NCT07169370
Many physical fitness centers and online exercise programs are not designed to support people with intellectual and developmental disabilities. To address this, the investigators are collaborating with SPIRIT Club, a company specializing in fitness for people with disabilities, to improve their platform. The goal is to create a new section of the platform specifically for people with chronic brain injury (CBI). The investigators will test and refine this new section to see how well it works for people with CBI in real-life situations. The research will focus on conducting a study with 60 people who have CBI to see if the new section helps them be more active and confident in their ability to exercise. Half will use the new section, and the other half will just be monitored for their activity. The investigators includes experts in fitness and rehabilitation for people with disabilities from industry, clinical settings, and research.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Columbus, Ohio, 43210, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A tailored, on-demand exercise and education program delivered via the SPIRIT Club virtual streaming platform. Content includes progressive adaptive workouts, safety videos, screening checkpoints, and prompts for a support person. Participants choose classes designed specifically for adults ≥9 months post-brain injury and after being placed in the appropriate archetype, complete activity surveys, and earn incentives for adherence. They are instructed on current physical activity guidelines (≥150 min moderate or ≥75 min vigorous activity per week) and to follow the CBI Pathway at their comfort level. Content was co-developed with clinical experts and survivors to ensure both usability and safety.
Other names: CBI Pathway, SPIRIT Club streaming fitness platform
Time frame: From enrollment through completion of the intervention (Week 8).
Feasibility will be assessed over the intervention period using recruitment rate (number of enrolled participants relative to those approached) as an objective indicator.
Time frame: From enrollment through completion of the intervention (Week 8).
Feasibility will be assessed over the intervention period using attendance (number of sessions completed) as an objective indicator.
Time frame: From enrollment through completion of the intervention (Week 8).
Feasibility will be assessed over the intervention period using attrition rate (proportion withdrawing before end of the intervention period as an objective indicator.
Time frame: From enrollment through completion of the intervention (Week 8).
Feasibility will be assessed over the intervention period using unplanned study-team contacts (number of emails and/or calls outside scheduled check-ins; total and per participant) as an objective indicator.
Time frame: From enrollment through completion of the intervention (Week 8).
Feasibility will be assessed over the intervention period using accessibility issues (number of instances where participants could not successfully acquire or use the streaming platform or data-collection tools; participant and/or staff team reported) as an objective indicator.
Time frame: From enrollment through completion of the intervention (Week 8).
Safety will be assessed through the documentation of exercise-related adverse events (number per participant and total over the intervention period).
Time frame: At program end (Week 8).
Acceptability will be evaluated immediately after the 8-week program or at the time of withdrawal using an electronically administered survey. The investigators will assess acceptability based on answers to a 5-point satisfaction scale (1 = very dissatisfied to 5 = very satisfied) for (1) overall program content and (2) usability and a series of binary yes/no responses to the following questions: "Was the program worth the participant's time?" and "Would the participant recommend it to others with CBI?"; and open-ended comments capturing likes, dislikes, and improvement suggestions.
Time frame: Baseline and Week 8
Electronic survey administered to participant. Change in total score on the validated 6-item exercise self-efficacy scale, from baseline to Week 8, which assesses participants' confidence to engage in physical activity despite common barriers.
Time frame: From enrollment through completion of the intervention (Week 8).
Activity is monitored using a Fitbit Inspire 3 wearable device, which captures daily step count.
Time frame: From enrollment through completion of the intervention (Week 8).
This outcome provides a comprehensive assessment of participants' physical activity patterns by a Fitbit Inspire 3 wearable device, which captures active minutes in intensity zones.
Time frame: Weekly summaries during Weeks 1-8.
Utilization metrics will be drawn from the SPIRIT Club streaming platform's automatic logs on a weekly basis (Weeks 1-8), including total number of classes initiated These data quantify how frequently and intensively participants engage with the CBI Pathway.
Time frame: Weekly summaries during Weeks 1-8.
Utilization metrics will be drawn from the SPIRIT Club streaming platform's automatic logs on a weekly basis (Weeks 1-8), including cumulative minutes of video streamed (group total and per participant).
Time frame: From enrollment through completion of the intervention (Week 8)
The total number of activities completed each day, as measured by a participant-completed daily activity log.
Time frame: From enrollment through completion of the intervention (Week 8).
The total duration of activity in minutes each day, as measured by a participant-completed daily activity log.
Time frame: Baseline and Week 8
Electronic survey administered to participant. Change in total score on the validated 8-item questionnaire, from baseline to Week 8, that assesses the extent to which an individual engages in a health-promoting lifestyle, specifically with physical activity. For each item, participants rate how often they engage in the described behavior on a 4-point scale (1=Never, 2=Sometimes, 3=Often, 4=Routinely). Total scores are calculated by summing the responses, with higher scores indicating a more health-promoting lifestyle.
Interested in participating?
Request InfoOhio State University
Other
SPIRIT Club CBI Pathway: A Novel Streaming Platform for Physical Activity and Wellness Promotion for Chronic Brain Injury Survivors
Acronym: SPIRITClubCBI
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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