Northeastern University
Boston, Massachusetts, 02120, United States
NCT Number: NCT06494592
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.
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Notify Me18 year–55 year
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02120, United States
This is a 12-week two arm pilot randomized control trial comparing two types of exercise interventions. Both groups will complete three 30-minute remote exercise sessions weekly, via Zoom delivered by a trained interventionist and supervised by a dedicated safety officer. Participants will be randomly assigned to either aerobic or balance based exercise for the duration of the study. Participants will sign informed consent in person during a baseline visit where measures of brain (magnetic resonance imaging [MRI] and electroencephalography [EEG]), cognition, patient reported outcomes and lifestyle questionnaires are collected. Participants will repeat this session in-person at the end of the 12-week intervention. Participants will wear a wrist-worn Actigraph for 7 consecutive days at 3 time points throughout the intervention period (once each month) to collect daily physical activity levels and sleep metrics. Both interventions will be individualized and progressive in terms of intensity and difficulty. The exercise interventions sessions will be thresholded at a heart rate of 80% symptom threshold assessed at baseline using a modified cycle and fitness test.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
*All potential participants who do not have an official concussion diagnosis from a physician or were not recruited directly from Concussion and Brain Injury clinic at Beth Israel Deaconess Medical Center (BIDMC) will have a phone-based consultation with a trained neurologist from BIDMC to confirm a diagnosis of mTBI, (i.e. any loss of consciousness of up to 30 mins, any loss of memory for events immediately before or after the accident for as much as 24h, any alteration in mental state at the time of the accident and a Glasgow coma score of 13 to 15) (Marshall et al., 2012) per a reliance agreement between Beth Israel Deaconess medical center and northeastern university.
Exclusion criteria
Participants in the aerobic exercise intervention group will engage in a virtual aerobic exercise intervention three times a week for 12 weeks for a 30-minute session (5 minute warm up, 20 minutes of aerobic exercise, 5 minutes cooldown) and will receive information about the session prior to their appointment. Sessions have a goal of reaching at least 20 minutes of supervised exercise performed at 80% of the heart rate at symptom threshold.
Participants in the balance exercise intervention group will participate in a staff-led virtual session three times a week for 12 weeks for a 30-minute session and will receive information about the session prior to their appointment. This group will focus on improving balance, with some additional work on flexibility and strength.
Time frame: 12 Weeks
Cognitive task evaluating executive functioning and processing speed is administered at Baseline and Endpoint at 12 weeks.
Time frame: 12 Weeks
Cognitive task evaluating immediate and delayed memory is administered at Baseline and Endpoint at 12 weeks.
Time frame: 12 Weeks
Cognitive task evaluating verbal fluency is administered at Baseline and Endpoint at 12 weeks.
Time frame: 12 Weeks
Completed and analyzed after Baseline and Endpoint via MRI. Diffusion weighted imaging used to measure changes in white matter microstructure.
Time frame: 12 Weeks
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.
Time frame: 12 Weeks
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.
Time frame: 12 Weeks
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.
Time frame: 12 Weeks
From eyes-open and eyes-closed scans: EEG power metrics within the canonical frequency bands (delta, theta, alpha, beta1, beta2, gamma).
Time frame: 12 Weeks
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.
Time frame: 12 Weeks
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.
Time frame: 12 Weeks
Questionnaire collected at Baseline and Endpoint: Self-reported global and cognitive health.
Time frame: 12 Weeks
Questionnaire collected at Baseline and Endpoint. Self-Reported Questionnaire about sleep duration and quality.
Time frame: 12 Weeks
Questionnaire collected at Baseline and Endpoint. Self-reported physical activity measurement.
Time frame: 12 weeks
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.
Northeastern University
Other
The Exercise and Concussion Health Study (TECHS)
Acronym: TECHS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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