SPIRIT Club Chronic Brain Injury Exercise Platform

Official title

SPIRIT Club CBI Pathway: A Novel Streaming Platform for Physical Activity and Wellness Promotion for Chronic Brain Injury Survivors

Overview

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.

Interventions

• Behavioral SPIRIT Club CBI Pathway
  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

Primary outcome measures

• Recruitment Rate [Time frame: From enrollment through completion of the intervention (Week 8).]
• Attendance of SPIRIT Club CBI Pathway Sessions [Time frame: From enrollment through completion of the intervention (Week 8).]
• Attrition Rate [Time frame: From enrollment through completion of the intervention (Week 8).]
• Unplanned Study-team contacts during enrollment [Time frame: From enrollment through completion of the intervention (Week 8).]
• Accessibility Issues [Time frame: From enrollment through completion of the intervention (Week 8).]
• Safety of the SPIRIT Club CBI Pathway Platform [Time frame: From enrollment through completion of the intervention (Week 8).]
• Acceptability Survey [Time frame: At program end (Week 8).]
• Exercise Self-Efficacy Scale Score [Time frame: Baseline and Week 8]

Secondary outcome measures (6)

• Step Count [Time frame: From enrollment through completion of the intervention (Week 8).]
• Active Minutes [Time frame: From enrollment through completion of the intervention (Week 8).]
• Platform Utilization - Total Classes Initiated [Time frame: Weekly summaries during Weeks 1-8.]
• Platform Utilization - Minutes of Video Streamed [Time frame: Weekly summaries during Weeks 1-8.]
• Daily Activity Log - Tracked Activity Counts [Time frame: From enrollment through completion of the intervention (Week 8)]
• Daily Activity Log - Tracked Activity Minutes [Time frame: From enrollment through completion of the intervention (Week 8).]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

United States · 1 center

• Ohio State University Wexner Medical Center — Columbus

Identifiers

NCT: NCT07169370 · 2024H0167 · R44HD112248

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗