SPIRIT Club Exercise Platform for Traumatic Brain Injury

(SPIRITClubCBI Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Uncontrolled blood pressure, Severe joint disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new section of an online exercise platform, the SPIRIT Club CBI Pathway, designed specifically for individuals with chronic brain injury (CBI). The trial aims to determine if the platform helps these individuals become more active and confident in their ability to exercise. Participants will either use the platform or have their activity monitored. Individuals who have had a brain injury for at least 9 months, can walk or stand with some assistance, and currently exercise less than an hour a week may be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance exercise options for individuals with CBI.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this platform is safe for people with chronic brain injury?

In a previous study, researchers found that the SPIRIT Club CBI Pathway was safe for people with traumatic brain injury (TBI), with no major side effects reported. The program is designed to be safe and effective for those with brain injuries, offering adjustable exercise options to meet individual needs and reduce potential risks.

While specific data on side effects is limited, the program supports safe physical activity. Participants in past studies did not report major issues, suggesting the program's safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SPIRIT Club CBI Pathway because it offers a tailored approach for traumatic brain injury (TBI) survivors, combining educational content with adaptive exercise programs. Unlike traditional therapies that may focus primarily on physical rehabilitation, this platform integrates continuous activity monitoring through a Fitbit Inspire 3, offering real-time feedback and motivation. This can empower individuals and their caregivers to actively participate in their recovery journey, promoting a holistic improvement in both physical and cognitive well-being.

What evidence suggests that the SPIRIT Club CBI Pathway is effective for chronic brain injury?

Research shows that the SPIRIT Club CBI Pathway is designed to help people with chronic brain injuries (CBI) become more active and confident in their exercise routines. The program offers special exercise plans and educational materials specifically for those with CBI. In this trial, participants in the SPIRIT Club CBI Pathway arm will receive free, two-month access to this on-demand streaming platform, along with a Fitbit Inspire 3 for activity monitoring. While data collection on its effectiveness continues, the program addresses common challenges faced by people with brain injuries, such as low physical activity and motivation. Early results suggest that the program is easy to follow and may help increase activity levels. This personalized support aims to meet specific needs, potentially improving overall health and well-being for individuals with CBI. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with chronic brain injury (CBI) who are interested in improving their physical activity and exercise confidence. The study aims to help those who may not be served well by traditional fitness centers or online programs.

Inclusion Criteria

It has been at least 9 months since my injury.

Currently exercising less than 60 minutes per week

I can understand and follow simple instructions.

Exclusion Criteria

Regular participation (2 or more days per week) in a structured fitness program or platform (e.g., group exercise classes or personal training)

I can't move safely on my own and don't have someone to help me participate in the study.

I don't have medical issues that stop me from exercising.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive access to the SPIRIT Club CBI Pathway platform for 8 weeks, with activity monitoring using a Fitbit Inspire 3

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SPIRIT Club CBI Pathway

Trial Overview

The SPIRIT Club CBI Pathway, a new section of an exercise platform tailored for people with CBI, is being tested. Participants will either use this new pathway or just have their activity monitored to compare the effects on physical activity levels.

How Is the Trial Designed?

Group I: SPIRIT Club CBI Pathway Experimental Treatment 1 Intervention

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.

Group II: Activity Monitoring Only Active Control 1 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.

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07169370

SPIRIT Club Chronic Brain Injury Exercise Platform

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 ...

2.

withpower.com

withpower.com/trial/phase-chronic-brain-injury-8-2025-660ba

SPIRIT Club Exercise Platform for Traumatic Brain Injury ...

... SPIRIT Club CBI Pathway will have tolerable side effects & efficacy for patients with Traumatic Brain Injury and Traumatic Brain Injury. Learn more about the

3.

thelancet.com

thelancet.com/article/S1474-4422(22)00309-X/fulltext

Traumatic brain injury: progress and challenges in ...

Around 50% of adult patients with mild TBI presenting to hospital do not recover to pre-TBI levels of health by 6 months after their injury. Fewer than 10% of ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3895622/

Advancing the care for traumatic brain injury

Simulation studies with TBI trial data showed that covariate adjustment for seven strong predictors of outcome increase statistical efficiency up to 30% in more ...

5.

tandfonline.com

tandfonline.com/doi/full/10.1080/02699052.2025.2507554

15th World Congress on Brain Injury Abstracts

However, outcomes among elderly traumatic brain injury (TBI) patients on DOACs remain unknown. In this study, we sought to describe how ...

6.

4g5ku1mlib.execute-api.us-east-1.amazonaws.com

4g5ku1mlib.execute-api.us-east-1.amazonaws.com/prod/go/KkrTsgi

RePORTER

SPIRIT Club CBI Pathway: A novel streaming platform for physical activity and wellness promotion for chronic brain injury survivors.

7.

cdc.gov

cdc.gov/traumaticbraininjury/pdf/tbi_report_to_congress_epi_and_rehab-a.pdf

Traumatic Brain Injury In the United States

Although data are limited, estimates based on data from two states indicate that. 3.2 million–5.3 million persons in the United States are living with a TBI- ...