SPIRIT Club Chronic Brain Injury Exercise Platform

NCT07169370 | Recruiting DMC

• 2 other identifiers: 2024H0167R44HD112248
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Brain Injury

Keywords

fitness platform; chronic brain injury

Outcome Measures

Primary Outcomes (8)

• 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

  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

Secondary Outcomes (6)

• 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)

Other Outcomes (1)

• Health-Promoting Lifestyle Profile II (HPLP II) Physical Activity Domain

  Baseline and Week 8

Study Arms (2)

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.

Behavioral: SPIRIT Club CBI Pathway

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.

Interventions

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.

Also known as: CBI Pathway, SPIRIT Club streaming fitness platform

SPIRIT Club CBI Pathway

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older with chronic brain injury (CBI)
• At least 9 months post-injury
• Is able to able to be able to demonstrate the ability to meet at least one of the following functional mobility scenarios: 1) able to walk with or without an assistive device or with no more than contact guard assist from a caregiver for steadiness checks and proprioceptive support, 2) able to stand up from a chair with no assistance or no more than contact guard assist from a caregiver for steadiness and proprioceptive support, and/or 3) able to maintain steady seated balance in a chair or wheelchair and able to lift at least one limb with minimal assist (\<25%) from a caregiver against gravity
• Currently exercising less than 60 minutes per week
• Able to follow simple commands
• Participant is his/her own legal authorized representative (LAR) or LAR is able to verify they can follow simple commands and participate in study and support consenting and participation processes
• Provides confirmation of medical clearance from physician to participate in moderate levels of activity without supervision from a licensed healthcare provider

You may not qualify if:

• Unsafe independent functional mobility observed during the functional mobility screen and no available caregiver/carepartner to facilitate participation in the study and provide assistance while using the SPIRIT Club platform
• Being advised by any healthcare provider to avoid or restrict participation in moderate to high-intensity physical activity
• Uncontrolled blood pressure, unstable angina, severe joint disease, uncontrolled or untreated dizziness or vertigo, or other medical issue precluding exercises leading to lack of clearance from a physician
• \- e.g.,
• Unable to follow simple commands or persistent post-traumatic amnesia
• Presence of expressive aphasia
• Lack of fluency in English
• Unable to follow simple commands or persistent post-traumatic amnesia
• Regular participation (2 or more days per week) in a structured fitness program or platform (e.g., group exercise classes or personal training)
• Regular participation (average of 1 or more days per week) in physical therapy services specifically for brain injury rehabilitation

Sponsors & Collaborators

• Ohio State University: lead
• National Institutes of Health (NIH): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Links

• 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.

MeSH Terms

Conditions

Brain Injury, Chronic

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 11, 2025
• Study Start: November 11, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)