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The Exercise and Concussion Health Study

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Conditions

Concussion, MildConcussion, BrainTBI (Traumatic Brain Injury)TBIBrainConcussion

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Exercise and Concussion Health Study (TECHS)

Quick Facts

Study Start:2023-02-01
Study Completion:2025-09-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06494592

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Suffered from a clinically diagnosed mild traumatic brain injury (concussion) within 1 year of injury.
  2. * Men and women of all ethnicities/races and socio-economic status.
  3. * 18-55 years.
  4. * Signed Informed consent.
  5. * 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.
  6. * Normal or corrected-to-normal vision based on the minimal 20/20 standard in order to complete the cognitive tasks (below 20/20 vision).
  7. * Able to speak, read, and write English.
  8. * Ambulatory without pain or the assistance of walking devices.
  9. * Reliable means of transportation.
  10. * No diagnosis of a neurological disease.
  11. * MRI compatible.
  12. * No brain bleeds.
  1. * 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.
  2. * Prior diagnosis of cognitive or physical disability (severe asthma, epilepsy, chronic kidney disease, and dependence upon a wheelchair/walking aid).
  3. * Not fluent in English.
  4. * Not medically cleared for exercise.
  5. * Not MRI compatible.
  6. * No history of vasovagal episodes. (sudden drops in heart rate, poor perfusion, constant dizziness)
  7. * History of brain bleeds or strokes.
  8. * Neurological condition (MS, Parkinson's, Dementia, MCI).
  9. * Current treatment for congestive heart failure, angina, uncontrolled arrhythmia, deep-vein thrombosis or other cardiovascular events.
  10. * Myocardial infarction, coronary artery bypass grafting, angioplasty or other cardiac conditions in the past year.
  11. * Regular use of an assisted walking device.

Contacts and Locations

Study Locations (Sites)

Northeastern University
Boston, Massachusetts, 02120
United States

Collaborators and Investigators

Sponsor: Northeastern University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-01
Study Completion Date2025-09-11

Study Record Updates

Study Start Date2023-02-01
Study Completion Date2025-09-11

Terms related to this study

Keywords Provided by Researchers

  • Brain
  • TBI
  • Concussion

Additional Relevant MeSH Terms

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