Exercise compared to passive stretching in subjects who have sustained a mild traumatic brain injury

Not Applicable

• Conditions: Concussion; Mild traumatic brain injury; Emergency medicine - Other emergency care; Neurological - Other neurological disorders; Injuries and Accidents - Other injuries and accidents; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation

• Registration Number: ACTRN12623000398606
• Lead Sponsor: The Alfred

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-04-19
• Last Update Posted: 24 April 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 296

Inclusion Criteria

Participants will be patients with mild traumatic brain injury (mTBI) presenting to the Emergency Department (ED) within 48 hours of injury. Eligible patients will have a diagnosis of mTBI as per treating clinical staff. mTBI will be defined according to the WHO Collaborating Task Force on mTBI criteria, which requires an acute brain injury resulting from mechanical energy to the brain from external physical forces and (i) one or more of the following: confusion or disorientation, loss of consciousness (LOC) for 30 minutes or less, post traumatic amnesia (PTA) for less than 24 hours, and/or other transient neurological abnormalities such as focal signs or seizure; (ii) a Glasgow Coma Scale (GCS) of 13-15 after 30 minutes, or upon presentation for healthcare. Ambulance records and hospital notes will be reviewed to confirm the details of memories described by participants.

Exclusion Criteria

(1) Evidence of focal neurological deficit;
(2) Inability to exercise because of orthopaedic injury, cervical spine injury, diabetes, or known heart disease;
(3) Increased cardiac risk according to American College of Sports Medicine criteria
(4) History of moderate or severe TBI, defined as a brain injury with an associated Glasgow Coma Scale score of 12 or less;
(5) Current diagnosis of and treatment with medication for attention-deficit/hyperactivity disorder, learning disorder, depression, anxiety, or history of more than 3 prior concussions
(6) sustaining another head injury during the research period before recovery;
(7) limited English proficiency precluding completion of measures;
(8) no symptoms exceeding pre-injury levels on the Rivermead Post-Concussion Symptoms Questionnaire, or no more than 2 mild symptoms exceeding pre-injury levels at initial clinical visit; and
(9) an ability to exercise to exhaustion without symptom exacerbation on the first visit

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of days to recovery, defined as the first symptom-free day retrospectively identified on the Rivermead Post-Concussion Symptom Questionnaire<br>[30 days after allocation to study group, assessed on a daily basis]

Secondary Outcome Measures

Name	Time	Method
Inflammatory factor IL-1B level, measured in plasma samples<br><br>[7, 14, 21 and 28 days post-commencement of intervention];Inflammatory factor (IL-18) level, measured in plasma samples[7, 14, 21 and 28 days post-commencement of intervention];Vascular endothelial growth factor levels, measured in plasma samples[7, 14, 21 and 28 days post-commencement of intervention];Brain derived neurotrophic factor level, measured in plasma samples[7, 14, 21 and 28 days post-commencement of intervention];Neurofilament light levels, measured in plasma samples[7, 14, 21 and 28 days post-commencement of intervention];tau levels, measured in plasma samples[7, 14, 21 and 28 days post-commencement of intervention];Glial fibrillary acidic protein levels, measured in plasma samples[7, 14, 21 and 28 days post-commencement of intervention]