Brain Injury, Concussion
Conditions
Brief summary
Adolescents with concussion will be randomly assigned to a treatment group where they will receive sub-threshold exercise, or assigned to a placebo group where they will receive structured stretching exercises. Both groups will receive standard medical coverage with regular clinic visits. All participants will record symptoms daily on a dedicated web site. All participants will be evaluated at time 1 with (1) structured physical exam, and (2) structured exercise stress test which is terminated when there is symptom exacerbation. The primary outcome measure is time to recovery where recovery is defined as (1) asymptomatic for two consecutive days, and (2) ability to exercise to exhaustion without exacerbation of symptoms, and (3) confirmed by a physician based on a structured physical exam.
Detailed description
Adolescents with concussion will be randomly assigned to a treatment group where they will receive sub-threshold exercise, or assigned to a placebo group where they will receive structured stretching exercises. Both groups will receive standard medical coverage with regular clinic visits. All participants will record symptoms daily on a dedicated web site. All participants will be evaluated at time 1 with (1) structured physical exam, and (2) structured exercise stress test which is terminated when there is symptom exacerbation. The primary outcome measure is time to recovery where recovery is defined as (1) asymptomatic for two consecutive days, and (2) ability to exercise to exhaustion without exacerbation of symptoms, and (3) confirmed by a physician based on a structured physical exam.
Interventions
OTHERSub-Threshold exercise prescription
Participants will be given a prescription to exercise at 80% of their threshold HR for symptom exacerbation. HR Threshold will be monitored weekly and exercise level increased accordingly.
OTHERStructured stretching prescription
Participants will be given a prescription for daily stretching lasting approximately 20 minutes.
Sponsors
National Center for Advancing Translational Sciences (NCATS)
University at Buffalo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Adolescent with concussion injury from sports within first 10 days
Exclusion criteria
* Evidence of focal neurologic deficit; ADHD; history of moderate or severe TBI; greater than 3 prior concussions (or having history of long recovery from concussion, \>3 mths); inability to understand English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time (in Days) to Recovery | 2 to 180 days | Time (in days) to recovery (Recovery is asymptomatic+able to exercise to exhaustion without symptom exacerbation+judged recovered by MD with structured physical exam.) |
Countries
United States
Participant flow
Pre-assignment details
Out of 165 eligible candidates, 113 were randomized, 10 were lost to follow-up and 103 were included in the analysis.
Participants by arm
| Arm | Count |
|---|---|
| Aerobic Exercise Participants will receive an exercise prescription based on their heart rate threshold (HRT) for symptom exacerbation during the Buffalo Concussion Treadmill Test (BCTT). The script will ask the participant to exercise one a day for 20 minutes at 80% of HRT. Participants will wear a smart watch to monitor their frequency, actual time and HR during exercise. Treatment will continue until participant is fully recovered from their concussion. Intervention: Sub-Threshold exercise prescription | 57 |
| Stretching Exercise Participants will receive a prescription for stretching exercises that they will be asked to do daily. Participants will wear a smart watch to monitor their frequency, actual time and HR during exercise. Treatment will continue until participant is fully recovered from their concussion. Intervention: Structured stretching exercise prescription. | 56 |
| Total | 113 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Illness unrelated to study intervention | 1 | 0 |
| Overall Study | Lost to Follow-up | 3 | 4 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Aerobic Exercise | Total | Stretching Exercise |
|---|---|---|---|
| Age, Continuous | 15.3 Years STANDARD_DEVIATION 1.6 | 15.3 Years STANDARD_DEVIATION 1.6 | 15.4 Years STANDARD_DEVIATION 1.7 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 57 Participants | 113 Participants | 56 Participants |
| Sex: Female, Male Female | 26 Participants | 52 Participants | 26 Participants |
| Sex: Female, Male Male | 31 Participants | 61 Participants | 30 Participants |
| Time since injury | 4.9 Days STANDARD_DEVIATION 2.2 | 4.9 Days STANDARD_DEVIATION 2.3 | 4.8 Days STANDARD_DEVIATION 2.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 51 |
| other Total, other adverse events | 0 / 52 | 0 / 51 |
| serious Total, serious adverse events | 0 / 52 | 0 / 51 |
Outcome results
Primary
Time (in Days) to Recovery
Time (in days) to recovery (Recovery is asymptomatic+able to exercise to exhaustion without symptom exacerbation+judged recovered by MD with structured physical exam.)
Time frame: 2 to 180 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Aerobic Exercise | Time (in Days) to Recovery | 13 Days |
| Stretching Exercise | Time (in Days) to Recovery | 17 Days |