The Exercise and Concussion Health Study
NCT Number: NCT06494592
Acronym: TECHS
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Concussion, Mild|Concussion, Brain|TBI (Traumatic Brain Injury)|TBI
Interventions: BEHAVIORAL: Aerobic Exercise|BEHAVIORAL: Balance Exercise
Sponsor: Northeastern University
Sex: ALL
Age: ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-02-01
Completion Date: 2026-01
Locations: Northeastern University, Boston, Massachusetts, 02120, United States

Summary:
This study aims to investigate the effect of two different physical exercise interventions on the brain, cognition and patient reported outcomes following a mild traumatic brain injury (mTBI) in community-dwelling adults.

Physical exercise as an intervention for mTBI has great potential yet there is limited high-quality evidence of its effect. Additionally, while standardized exercise protocols for sport-related concussion exist, a similar program is not available to members of the general public who have suffered a mTBI. This study therefore aims to test the effect of a 3-month exercise protocol either focusing on balance or aerobic exercises. The results from the study may lead to advances in evidenced-based mTBI management and provide clinicians with an effective intervention that can improve brain and cognitive recovery after mTBI.

Primary Outcome Measures: Trail Making Test, Cognitive task evaluating executive functioning and processing speed is administered at Baseline and Endpoint at 12 weeks., 12 Weeks|Hopkins Verbal Learning Test, Cognitive task evaluating immediate and delayed memory is administered at Baseline and Endpoint at 12 weeks., 12 Weeks|Letter and Category Fluency Test, Cognitive task evaluating verbal fluency is administered at Baseline and Endpoint at 12 weeks., 12 Weeks
Secondary Outcome Measures: White Matter Diffusion Properties, Completed and analyzed after Baseline and Endpoint via MRI. Diffusion weighted imaging used to measure changes in white matter microstructure., 12 Weeks|Resting State Functional Connectivity, Completed and analyzed after Baseline and Endpoint via MRI. Functional MRI scan used to measure changes in resting state brain function via resting state connectivity metrics., 12 Weeks|Brain Morphology, Completed and analyzed after Baseline and Endpoint via MRI. Anatomical T1w MRI scan used to measure volume and determine changes in volume over the course of the intervention., 12 Weeks|Cerebral Blood Flow, Completed and analyzed after Baseline and Endpoint via MRI. Arterial spin labeling used to measure changes in cerebral blood flow with total cerebral blood flow change., 12 Weeks|Electroencephalography (EEG) Power Metrics, From eyes-open and eyes-closed scans: EEG power metrics within the canonical frequency bands (delta, theta, alpha, beta1, beta2, gamma)., 12 Weeks|EEG Scan- Aperiodic Metrics, From eyes-open and eyes-closed scans: Aperiodic metrics derived from the Fitting Oscillations one over F (FOOOF) algorithm being the aperiodic offset and exponent along with peak power and bandwidth., 12 Weeks|Daily Physical Activity Levels- Accelerometers, Wrist-worn Actigraph device is utilized to collect physical activity and sleep metrics at three time points for 7 consecutive days during the 12-week participation., 12 Weeks|PROMIS- Patient-Reported Outcomes Measurement Information Systems, Questionnaire collected at Baseline and Endpoint: Self-reported global and cognitive health., 12 Weeks|Pittsburgh Sleep Quality Index, Questionnaire collected at Baseline and Endpoint. Self-Reported Questionnaire about sleep duration and quality., 12 Weeks|International Physical Activity Questionnaire., Questionnaire collected at Baseline and Endpoint. Self-reported physical activity measurement., 12 Weeks|Symptomology, California Interscholastic Federation Graded Concussion Symptom checklist, collected during the baseline session, throughout each intervention session and again at post-test session to assess concussion-related symptoms., 12 weeks