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| ID | Type | Description | Link |
|---|---|---|---|
| R44HD112248 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPIRIT Club CBI Pathway | Experimental | Participants receive free, two-month access to the SPIRIT Club CBI Pathway on-demand streaming platform, featuring targeted educational modules and adaptive exercise programming designed specifically for CBI survivors and their caregivers, plus a Fitbit Inspire 3 to wear continuously for the purposes of activity monitoring over the intervention period. |
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| Activity Monitoring Only | No Intervention | There is no intervention in this Arm. In order to track activity, participants will undergo the same activity monitoring procedures as the experimental group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPIRIT Club CBI Pathway | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Rate | Feasibility will be assessed over the intervention period using recruitment rate (number of enrolled participants relative to those approached) as an objective indicator. | From enrollment through completion of the intervention (Week 8). |
| Attendance of SPIRIT Club CBI Pathway Sessions | Feasibility will be assessed over the intervention period using attendance (number of sessions completed) as an objective indicator. | From enrollment through completion of the intervention (Week 8). |
| Attrition Rate | Feasibility will be assessed over the intervention period using attrition rate (proportion withdrawing before end of the intervention period as an objective indicator. | From enrollment through completion of the intervention (Week 8). |
| Unplanned Study-team contacts during enrollment | 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. | From enrollment through completion of the intervention (Week 8). |
| Accessibility Issues | 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. | From enrollment through completion of the intervention (Week 8). |
| Safety of the SPIRIT Club CBI Pathway Platform |
| Measure | Description | Time Frame |
|---|---|---|
| Step Count | Activity is monitored using a Fitbit Inspire 3 wearable device, which captures daily step count. | From enrollment through completion of the intervention (Week 8). |
| Active Minutes | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Health-Promoting Lifestyle Profile II (HPLP II) Physical Activity Domain | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Wexner Medical Center | Recruiting | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| Official homepage for SPIRIT Club, a virtual on-demand fitness streaming platform offering adaptive, progressive exercise classes and educational modules for people with disabilities, including those with chronic brain injury. | View source |
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To protect the privacy and confidentiality of our study participants, individual participant data (IPD) will not be shared.
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| ID | Term |
|---|---|
| D020208 | Brain Injury, Chronic |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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This is a randomized, parallel-assignment, single-masked interventional study with two arms:
Intervention Arm: Participants receive access to the SPIRIT Club CBI Pathway streaming platform and a Fitbit for continuous activity monitoring.
Control Arm: Participants receive a Fitbit alone, plus weekly check-ins, but no platform access.
Participants are randomized 1:1 and followed for 8 weeks. Outcome assessors remain masked to arm assignment. Primary feasibility and activity outcomes (e.g., tracked activity, exercise self-efficacy) are measured at baseline and week 8.
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The investigators operationally define 'Outcomes Assessor' for this trial as the biostatistician, who will be unaware of participant group assignments during the final data analysis.
The data for key outcomes, such as feasibility and acceptability, are generated directly by the participants themselves through their survey responses and interaction with the platform.
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Safety will be assessed through the documentation of exercise-related adverse events (number per participant and total over the intervention period).
| From enrollment through completion of the intervention (Week 8). |
| Acceptability Survey | 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. | At program end (Week 8). |
| Exercise Self-Efficacy Scale Score | 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. | Baseline and Week 8 |
| From enrollment through completion of the intervention (Week 8). |
| Platform Utilization - Total Classes Initiated | 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. | Weekly summaries during Weeks 1-8. |
| Platform Utilization - Minutes of Video Streamed | 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). | Weekly summaries during Weeks 1-8. |
| Daily Activity Log - Tracked Activity Counts | The total number of activities completed each day, as measured by a participant-completed daily activity log. | From enrollment through completion of the intervention (Week 8) |
| Daily Activity Log - Tracked Activity Minutes | The total duration of activity in minutes each day, as measured by a participant-completed daily activity log. | From enrollment through completion of the intervention (Week 8). |
| Baseline and Week 8 |
| D001930 | Brain Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |