Clinical trial NCT03170856: The Effects of a Sub-maximal Exercise Program on Adolescents Who Sustained a Concussion
Official title: The Effects of a Sub-maximal Exercise Program on Adolescents Who Sustained a Concussion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Concussion, Mild
Concussion, Brain
Concussion, Severe
Exertion; Excess
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
First posted: 2017-05-31
Enrollment: 41
Sex: ALL
Minimum age (years): 14
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomly assigned to either the exercise intervention group or the usual care group.
Primary purpose: TREATMENT

Brief summary: Patients who sustain a concussion will undergo a sub-maximal exercise protocol throughout their recovery. Cerebrovascular function, heart rate, and symptom severity, and exercise volume will be monitored throughout.

Detailed description: There has been recent change to the management of concussion, including the addition of exercise while a patient may still be experiencing symptoms. Some patients will be given a dose-dependent exercise prescription based on their own sub-maximal output. They will aerobically exercise at this given threshold for 8 weeks, while heart rate and symptom duration is tracked. Some patients will only follow physician prescribed exercise, while undergoing the same heart rate and symptom monitoring for 8 weeks.

Eligibility criteria: Inclusion Criteria:

* Experienced a concussion within the last 2 weeks. Concussion will be diagnosed by board-certified sports medicine physicians, and defined as a direct or indirect blow to the head, face, neck, or elsewhere that manifests with the presence of symptoms and neurological impairment
* Low or moderate cardiac risk according to American College of Sports Medicine
* Post-Concussion Symptom Scale (PCSS) score greater than 9

Exclusion Criteria:

* History of neurological surgery
* Seizure disorder
* Use of medication or medical device that would alter heart rate, blood pressure or autonomic function
* Any current, serious, chronic medical or psychiatric disease that, in the Principal Investigator's judgment, may interfere with study participation or data integrity
* Unable or unwilling to provide informed consent

Primary outcomes:
measure: Change in Vasoreactivity During Exercise at Baseline and 8-week Visits.
timeFrame: Measured at initial visit and 8-weeks.
measure: Change in Concussion Symptoms From Baseline, 4-weeks, and 8-weeks Post-injury, During an Exercise Intervention.
timeFrame: The PSCI symptom severity be a repeated measured at the time of injury, 4 weeks post-injury and 8 weeks post-injury, to look for a change in symptom score over the duration of the study.
Secondary outcomes:
measure: End-tidal CO2
timeFrame: Measured at initial visit and 8-week post injury visit.
measure: Heart Rate
timeFrame: Measured at initial visit and 8 weeks to look for a change as a person becomes asymptomatic.
measure: Volume of Self-reported Exercise Per Week
timeFrame: Average volume of exercise (min) that was self-reported by participants over the 8-week study period.
measure: Rate of Perceived Exhaustion at Baseline, 4-week, and 8-week Visits.
timeFrame: Measured at initial visit, 4 weeks and 8 weeks to look for a change in perceived exhaustion as a person becomes asymptomatic
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Spaulding Rehabilitation Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: William Meehan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Howell DR, Taylor JA, Tan CO, Orr R, Meehan WP 3rd. The Role of Aerobic Exercise in Reducing Persistent Sport-related Concussion Symptoms. Med Sci Sports Exerc. 2019 Apr;51(4):647-652. doi: 10.1249/MSS.0000000000001829.
citation: Howell DR, Lugade V, Taksir M, Meehan WP 3rd. Determining the utility of a smartphone-based gait evaluation for possible use in concussion management. Phys Sportsmed. 2020 Feb;48(1):75-80. doi: 10.1080/00913847.2019.1632155. Epub 2019 Jun 26.
citation: Howell DR, Brilliant AN, Oldham JR, Berkstresser B, Wang F, Meehan WP 3rd. Exercise in the first week following concussion among collegiate athletes: Preliminary findings. J Sci Med Sport. 2020 Feb;23(2):112-117. doi: 10.1016/j.jsams.2019.08.294. Epub 2019 Sep 7.
citation: Howell DR, Oldham J, Lanois C, Koerte I, Lin AP, Berkstresser B, Wang F, Meehan WP 3rd. Dual-Task Gait Recovery after Concussion among Female and Male Collegiate Athletes. Med Sci Sports Exerc. 2020 May;52(5):1015-1021. doi: 10.1249/MSS.0000000000002225.
citation: Howell DR, Brilliant AN, Meehan WP 3rd. Tandem Gait Test-Retest Reliability Among Healthy Child and Adolescent Athletes. J Athl Train. 2019 Dec;54(12):1254-1259. doi: 10.4085/1062-6050-525-18. Epub 2019 Oct 28.
citation: Howell DR, Hunt DL, Oldham JR, Aaron SE, Meehan WP 3rd, Tan CO. Postconcussion Exercise Volume Associations With Depression, Anxiety, and Dizziness Symptoms, and Postural Stability: Preliminary Findings. J Head Trauma Rehabil. 2022 Jul-Aug 01;37(4):249-257. doi: 10.1097/HTR.0000000000000718. Epub 2021 Jul 26.