Walking for TBI

(SWEAT-TBI Trial)

CW
Overseen ByCarly Wender, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a 3-month home-based walking program can improve thinking skills in individuals who have had a traumatic brain injury (TBI) for at least a year. Participants will either begin the exercise program immediately or after a 3-month waiting period. The program involves walking three times a week, gradually increasing the duration, with support from a trainer and a Fitbit to track progress. Ideal candidates have experienced thinking challenges since their TBI and can walk briskly without aid. As an Early Phase 1 trial, this research aims to understand how the walking program affects participants, offering them a chance to contribute to groundbreaking insights.

What prior data suggests that this walking exercise program is safe for people with TBI?

Studies have shown that walking programs for people with traumatic brain injury (TBI) are generally safe. For example, a 12-week digital walking exercise program improved participants' ability to function and was well-received by those with mild TBI. Another study found that a walking program delivered remotely was practical and safe for adults waiting for outpatient rehabilitation.

These findings suggest that walking exercises, like the one tested in the trial, are usually easy to handle and have few safety concerns. Participants in such programs often experience benefits without significant side effects.12345

Why are researchers excited about this trial?

Walking for traumatic brain injury (TBI) is unique because it offers a simple, non-invasive approach to support recovery. While traditional treatments for TBI often involve medications, physical therapy, and occupational therapy, this approach focuses on a structured walking program. Researchers are excited because it empowers patients to actively participate in their recovery from home, with guidance from an exercise leader and feedback via a FitBit. This method aims to enhance mobility and cognitive function, potentially offering a cost-effective and accessible complement to existing therapies.

What evidence suggests that walking might be an effective treatment for TBI?

This trial will compare a 12-week digital walking program with a wait-list control group. Studies have shown that such a program can significantly enhance the daily functioning of individuals with mild traumatic brain injury (TBI). This exercise also benefits mental health. Exercise, in general, improves thinking skills and supports the brain's healing after injury. Additionally, physical activity can aid in addressing balance and movement issues caused by TBI. Research consistently shows that staying active plays a crucial role in the recovery of TBI patients.13456

Are You a Good Fit for This Trial?

This trial is for adults who have had a traumatic brain injury (TBI) and are able to walk. Participants should be willing to follow a home-based walking program for three months.

Inclusion Criteria

Fluent in English
I was diagnosed with a traumatic brain injury over a year ago.
Self-report problems with thinking skills since the TBI diagnosis (e.g., processing information, learning or remembering, organizing, multitasking)
See 6 more

Exclusion Criteria

History of schizophrenia, bipolar disorder I or II, or substance-abuse disorders
I have been diagnosed with heart, blood pressure, diabetes, or kidney problems.
I regularly take medications that affect my thinking or mood.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 hour
1 visit (virtual)

Treatment

Participants engage in a 3-month home-based walking exercise program monitored by a trained exercise leader

12 weeks
Regular virtual meetings

Wait-list

Participants in the wait-list group maintain their regular routine for 3 months before starting the exercise program

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including repeat cognitive tests and questionnaires

12 weeks
1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Walking

Trial Overview

The study tests whether doing regular walking exercises at home for three months can help improve thinking skills in people with TBI. Some participants start right away, while others wait three months before beginning.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Behavioral: ExerciseExperimental Treatment1 Intervention
Group II: Wait ListActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials
190
Recruited
11,300+

Citations

Brain changes: aerobic exercise for traumatic brain injury ...

While aerobic exercise may meet many of these criteria, it is currently unknown how effective it is as a treatment for TBI across age and injury severity.

Impact of a Digitally Monitored Walking Program on ...

A 12-week digital walking exercise program significantly improved functional capacity in individuals with mTBI. Psychological health benefits were evident among ...

The Power of Exercise for Traumatic Brain Injury Recovery

It is shown to improve cognition and promote neuroplasticity, the brain's ability to rewire itself following injury. Exercise can also address balance, gait, ...

Effect of Exercise Training on Physical, Cognitive, and ...

- Traumatic brain injury (TBI) often causes problems with moving and balance, and thinking and emotions. Exercise can improve these things in people with other ...

A Remotely Delivered Progressive Walking Intervention for ...

This paper reports on a remotely delivered 8-week progressive walking intervention for adults with persisting symptoms of a mTBI. The results showed the ...

Physical Activity Guidelines for Traumatic Brain Injury

Examples of Balance Exercises include standing on one foot, tandem stance, walking heel to toe, standing on an unstable surface and all can be done with eyes ...