SPIRIT Club Chronic Brain Injury Exercise Platform (SPIRITClubCBI)

The Ohio State University

Status: Enrolling

Conditions: Chronic Brain Injury

Treatments: Behavioral: SPIRIT Club CBI Pathway

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07169370

R44HD112248 (U.S. NIH Grant/Contract)

2024H0167

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

SPIRIT Club CBI Pathway

Experimental group

Description:

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.

Treatment:

Behavioral: SPIRIT Club CBI Pathway

Activity Monitoring Only

No Intervention group

Description:

There is no intervention in this Arm. In order to track activity, participants will undergo the same activity monitoring procedures as the experimental group.