The Exercise and Concussion Health Study (TECHS)

The Exercise and Concussion Health Study (TECHS)

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.

Study Overview

• Status: Completed
• Conditions: TBI (Traumatic Brain Injury); Concussion, Mild; TBI; Concussion, Brain
• Intervention / Treatment: Behavioral: Aerobic Exercise; Behavioral: Balance Exercise

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02120
      • Northeastern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Suffered from a clinically diagnosed mild traumatic brain injury (concussion) within 1 year of injury.

  *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.

• Men and women of all ethnicities/races and socio-economic status.
• 18-55 years.
• Signed Informed consent.
• Physically fit enough to undergo exercise as screened using the Physical Activity Readiness Questionnaire (PAR-Q) and the cardiovascular section of the Health History & Demographics Questionnaire. An affirmative response (i.e., "yes") to any single item regarding an individual's health status is grounds for the necessary medical clearance before enrollment.
• Normal or corrected-to-normal vision based on the minimal 20/20 standard in order to complete the cognitive tasks (below 20/20 vision).
• Able to speak, read, and write English.
• Ambulatory without pain or the assistance of walking devices.
• Reliable means of transportation.
• No diagnosis of a neurological disease.
• MRI compatible.
• No brain bleeds.

Exclusion Criteria:

• Diagnosis of a moderate-to-severe TBI (Glasgow Coma Score of 3-12) or the presentation of skull breach and/or presence of known subdural hematoma.
• Prior diagnosis of cognitive or physical disability (severe asthma, epilepsy, chronic kidney disease, and dependence upon a wheelchair/walking aid).
• Not fluent in English.
• Not medically cleared for exercise.
• Not MRI compatible.
• No history of vasovagal episodes. (sudden drops in heart rate, poor perfusion, constant dizziness)
• History of brain bleeds or strokes.
• Neurological condition (MS, Parkinson's, Dementia, MCI).
• Current treatment for congestive heart failure, angina, uncontrolled arrhythmia, deep-vein thrombosis or other cardiovascular events.
• Myocardial infarction, coronary artery bypass grafting, angioplasty or other cardiac conditions in the past year.
• Regular use of an assisted walking device.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aerobic Exercise Group	Behavioral: Aerobic Exercise; 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.
Active Comparator: Balance Exercise Group	Behavioral: Balance Exercise; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Northeastern University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): September 11, 2025
• Study Completion (Actual): September 11, 2025

Study Registration Dates

• First Submitted: June 25, 2024
• First Submitted That Met QC Criteria: July 2, 2024
• First Posted (Actual): July 10, 2024

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Concussion; TBI; Brain
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: 22-10-15

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No