An interventional study of Sub-Threshold exercise prescription and Structured stretching prescription in Brain Injury and Concussion, sponsored by University at Buffalo. Completed at 1 site in United States. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-10-15.
Sponsored by University at Buffalo · Not applicable, Interventional, and Treatment
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.
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.
946 studies on the registry are indexed under Brain Injuries; 235 are open to participants now.
This study's enrollment of 113 is above the median of 41 across 612 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →University at Buffalo is the lead sponsor of 76 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.
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Exclusion Criteria:
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
Other: Sub-Threshold exercise prescription
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.
Other: Structured stretching 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.
Participants will be given a prescription for daily stretching lasting approximately 20 minutes.
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
| Milestone | Aerobic Exercise | Stretching Exercise |
|---|---|---|
| Started | 57 | 56 |
| Completed | 52 | 51 |
| Not completed | 5 | 5 |
| Withdrew: Lost to follow-up | 3 | 4 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Withdrew: Illness unrelated to study intervention | 1 | 0 |
Time (in days) to recovery (Recovery is asymptomatic+able to exercise to exhaustion without symptom exacerbation+judged recovered by MD with structured physical exam.)
| Days | Aerobic Exercise | Stretching Exercise |
|---|---|---|
| Time (in Days) to Recovery | 13 (10 to 18.5) | 17 (13 to 23) |
Collected over From enrollment to end of follow-up, up to 30 days.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Aerobic Exercise | 0/52 (0%) | 0/52 (0%) | 0/52 (0%) |
| Stretching Exercise | 0/51 (0%) | 0/51 (0%) | 0/51 (0%) |
| Age, Continuous(Years) | Aerobic Exercise | Stretching Exercise | Total |
|---|---|---|---|
| Mean | 15.3 ± 1.6 | 15.4 ± 1.7 | 15.3 ± 1.6 |
| Sex: Female, Male(Participants) | Aerobic Exercise | Stretching Exercise | Total |
|---|---|---|---|
| Female | 26 | 26 | 52 |
| Male | 31 | 30 | 61 |
| Race and Ethnicity Not Collected(Participants) | Aerobic Exercise | Stretching Exercise | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | Aerobic Exercise | Stretching Exercise | Total |
|---|---|---|---|
| United States | 57 | 56 | 113 |
| Time since injury(Days) | Aerobic Exercise | Stretching Exercise | Total |
|---|---|---|---|
| Median | 4.9 ± 2.2 | 4.8 ± 2.4 | 4.9 ± 2.3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — No plan to share data
Ran from Sep 2015 to primary completion in May 2018, 32 months.
Results were first posted in Oct 2025, 7 years 4 months after primary completion.
Of 284 non-industry interventional studies with no phase under Brain Injuries, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's 32 months is above that.
Counting every sponsor, half of 297 studies reached it within 24 months; a quarter within 12 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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