NCT07169370|RecruitingDMC
SPIRIT Club Chronic Brain Injury Exercise Platform
SPIRITClubCBI
SPIRIT Club CBI Pathway: A Novel Streaming Platform for Physical Activity and Wellness Promotion for Chronic Brain Injury Survivors
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SPIRITClubCBI
SPIRIT Club CBI Pathway: A Novel Streaming Platform for Physical Activity and Wellness Promotion for Chronic Brain Injury Survivors
Sponsor study identifier
Secondary identifiers
NIH
interventional
60
1 country
1
Study Start
November 11, 2025
Actual (reported)Primary Completion
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 28, 2025
Actual (reported)September 11, 2025
Actual (reported)November 11, 2025
Actual (reported)December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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).
Step Count
From enrollment through completion of the intervention (Week 8).
Active Minutes
From enrollment through completion of the intervention (Week 8).
Platform Utilization - Total Classes Initiated
Weekly summaries during Weeks 1-8.
Platform Utilization - Minutes of Video Streamed
Weekly summaries during Weeks 1-8.
Daily Activity Log - Tracked Activity Counts
From enrollment through completion of the intervention (Week 8)
Health-Promoting Lifestyle Profile II (HPLP II) Physical Activity Domain
Baseline and Week 8
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.
There is no intervention in this Arm. In order to track activity, participants will undergo the same activity monitoring procedures as the experimental group.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
First Submitted
August 28, 2025
Treatment of Traumatic Brain Injury With Hyperbaric Oxygen Therapy
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
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
Contact the study team to confirm eligibility.
First Posted
September 11, 2025
Study Start
November 11, 2025
Actual (reported)Primary Completion
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 4, 2026
Record last verified: 2026-03
To protect the privacy and confidentiality of our study participants, individual participant data (IPD) will not be shared.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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