The Exercise and Concussion Health Study

NCT06494592 | Completed

• 1 other identifier: 22-10-15
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Concussion, Mild; Concussion, Brain; TBI (Traumatic Brain Injury); TBI

Keywords

Brain; TBI; Concussion

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (11)

• White Matter Diffusion Properties

  12 Weeks

• Resting State Functional Connectivity

  12 Weeks

• Brain Morphology

  12 Weeks

• Cerebral Blood Flow

  12 Weeks

• Electroencephalography (EEG) Power Metrics

  12 Weeks

Study Arms (2)

Aerobic Exercise Group

EXPERIMENTAL

Behavioral: Aerobic Exercise

Balance Exercise Group

ACTIVE COMPARATOR

Behavioral: Balance Exercise

Interventions

Aerobic Exercise BEHAVIORAL

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.

Aerobic Exercise Group

Balance Exercise BEHAVIORAL

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.

Balance Exercise Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northeastern University: lead

Study Sites (1)

Northeastern University

Boston, Massachusetts, 02120, United States

Location

MeSH Terms

Conditions

Brain Concussion; Brain Injuries, Traumatic

Interventions

Exercise

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 10, 2024
• Study Start: February 1, 2023
• Primary Completion: September 11, 2025
• Study Completion: September 11, 2025
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

US (1)