Clinical trial NCT02969824: Post-acute Structured Exercise Following Sport Concussion
Official title: Post-acute Structured Exercise Following Sport Concussion: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Concussion, Brain
Keywords: Sport Injury
Concussion
Active Recovery
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2016-11-21
Enrollment: 50
Sex: ALL
Minimum age (years): 13
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate the effect of structured, standardized aerobic exercise (AE) compared to usual care on clinical recovery from sport-related concussion (SRC) within the post-acute phase of injury. Participants will be randomized into one of two groups: (1) Supervised Exercise Group: participants will complete a total of eight exercise sessions over the course of 11 days, starting at Day 3 post-injury (two sessions (first and mid-point) will be done in the lab, and the remained will be home-based sessions); (2) Usual Care Group: individuals will undergo a period of physical rest and standard care. For the purposes of this study, "rest" will be defined as the avoidance of any activities beyond those of daily living, including participation in sport and physical activity.

Detailed description: A number of physical, cognitive, somatic, and emotional symptoms commonly occur following sports-related concussion. The most recent Concussion in Sport Consensus Statement recommends an initial period of rest (24-48 hours), followed by more activity - gradual and progressive - while staying below their cognitive and physical symptom-exacerbation thresholds. While structured exercise is advised post-injury, the appropriate intensity, frequency, and duration of activity remains unclear. Furthermore, there is also evidence that too much physical activity may be related to worse outcomes, which necessitates the investigation on the appropriate prescription of exercise following concussion.

Early work identified the potential benefit of exercise in those with persistent symptoms after concussion. However, it is important to recognize that exercise must be structured and tailored as it has been found that athletes engaging in high levels of activity post-injury were associated with greater symptom burden and poorer cognitive abilities. Collectively, these findings further support the potential benefit of personalized, prescribed exercise post-concussion.

Additional evidence in support of sub-acute and acute exercise interventions following neurological insult exists for other conditions of the central nervous system, such as low back pain, whiplash, and stroke. For example, research suggests that bed rest may actually delay recovery from acute low back pain, and recommendations to resume regular activities as soon as possible following injury result in faster recovery times, less chronic disability, and fewer recurrent problems. While rest and collar restraint were previously the standard mode of treatment for whiplash, recent evidence suggests that early mobilization and exercise compared to more traditional rest strategies. In terms of stroke, it has been shown that mobilization within 24 hours of this type of injury can expedite recovery while also inducing the risk of complications.

Therefore, the purpose of this study is to examine the effect of a structured, standardized, subacute AE intervention in adolescents after SRC, on time to recovery compared to usual care. This study will provide meaningful information regarding the utility of AE intervention after concussion. Findings from these works may inform future usual care procedures post-injury, potentially providing the first known treatment to improve recovery after concussion.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with SRC by a physician at the David L. MacIntosh Sport Medicine Clinic
* Minimum of 13 years of age and a maximum of 25 years of age
* Able to speak and understand English

Exclusion Criteria:

* Have had a previous concussion within two weeks of the presenting SRC
* Have any co-morbid injuries (i.e. musculoskeletal/soft-tissue injuries, vestibular disorders)
* Have a pre-existing heart condition
* Have any uncontrolled seizure disorders or a history of medical or neurological conditions that affects cognitive functioning

Primary outcomes:
measure: Clinical recovery - Days to Medical Clearance
timeFrame: Up to 1-year post-injury
Secondary outcomes:
measure: Change in Symptoms
timeFrame: 28 Days: assessed at Days 7, 14, 21, 28, and 90 post-injury
measure: Change in Heart Rate Variability (HRV)
timeFrame: 28 Days: assessed at Days 7, 14, 21, 28, and 90 post-injury
measure: Change in Blood Pressure Variability (BPV)
timeFrame: 28 days: assessed at Days 7, 14, 21, 28, and 90 post-injury
measure: Change in Peripheral Blood Biomarkers
timeFrame: 28 Days: assessed at Days 7, 14, 21, 28, and 90 post-injury
measure: Change in Cognition
timeFrame: 28 Days: assessed at Days 7, 14, 21, 28, and 90 post-injury
measure: Salivary MicroRNA and DNA Collection
timeFrame: 28 Days: assessed at Days 7, 14, 21, 28, and 90 post-injury
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: David L. MacIntosh Sport Medicine Clinic
state: Ontario
city: Toronto
country: Canada
facility: Goldring Centre for High Performance Sport
state: Ontario
Study officials:
affiliation: University of Toronto
name: Michael Hutchison, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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