None listed
Conditions
Brief summary
Mild traumatic brain injury (mTBI) results in a range of debilitating symptoms including cognitive, sensory, and emotional deficits, sleep disturbances, and headaches. Despite increased awareness of the socioeconomic costs and risks of poor outcome, the clinical management of mTBI remains notoriously difficult because there are still no evidence-based interventions for individuals across the lifespan. Current treatment options for mTBI are sparse and not evidence-based, with the standard treatment for mTBI still being rest until asymptomatic. Initial studies led by members of our team have identified subthreshold aerobic exercise as a promising intervention for mTBI in adolescents. Findings from these studies show that this intervention may result in faster recovery and reduced incidence of persisting post-concussion symptoms; thereby allowing individuals to return to per-injury activities sooner. This intervention protocol is also straight forward and applicable in a vast range of clinical setting. However, studies are now required to extend and validate this subthreshold exercise intervention protocol as an effective mTBI intervention in adults. To address this knowledge gap, our complementary and interdisciplinary research team now propose a clinical trial to examine subthreshold aerobic exercise intervention in mTBI patients. We hypothesise that exercise intervention will improve recovery in mTBI patients. Based on these findings we will develop and distribute protocols/guidelines for both adolescent and adult mTBI patients that can be accessed and applied in clinical settings across Australia.
Interventions
All participants will then have an assessment of their exercise tolerance using the Buffalo Concussion Bike Test (BCBT) (approx. 1h). Specifically, these tests identify the heart rate (HR) at which mTBI symptom exacerbation occurs (i.e. Heart Rate Threshold [HRt]), used to establish the safe level of exercise for the consequent sub-symptom threshold aerobic exercise treatment of mTBI. Following baseline/pre-intervention procedures, randomisation will be carried out to assign to either the exerci
All participants will then have an assessment of their exercise tolerance using the Buffalo Concussion Bike Test (BCBT) (approx. 1h). Specifically, these tests identify the heart rate (HR) at which mTBI symptom exacerbation occurs (i.e. Heart Rate Threshold [HRt]), used to establish the safe level of exercise for the consequent sub-symptom threshold aerobic exercise treatment of mTBI. Following baseline/pre-intervention procedures, randomisation will be carried out to assign to either the exercise or passive stretching interventions. Reassessment on the abovementioned BCBT measures, including recalibrating the HRt, will be repeated weekly for 4 weeks by a research assistant/nurse who is blinded to the participants’ intervention allocation. Participants assigned to aerobic exercise intervention will be instructed to perform aerobic exercise each day on a stationary bike, at home or in a gym at the prescribed target HR, wearing a provided HR sensor (Apple Watch: version SE) to monitor HR. Participants can walk or jog if they do not have access to exercise equipment. They will be instructed not to stretch before or after aerobic exercise. The sub-symptom threshold aerobic exercise prescription target HR will be 80% of the HR achieved at symptom exacerbation on the BCBB at the most recent visit. Participants will be instructed to stop their exercise session if their symptoms increased by 2 or more points from their pre-exercise symptom level (on a 10-point visual analogue scale) or at 20 minutes, whichever comes first. They will be told to rest apart from the prescribed exercise and not participate in other physically engaging activities. Rest will also include advice on limiting activities that exacerbate symptoms, such as excessive use of mobile phones or computers.
Sponsors
The Alfred
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed