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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR001412 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aerobic Exercise | Experimental | 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 |
|
| Stretching Exercise | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sub-Threshold exercise prescription | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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.) | 2 to 180 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Leddy, MD | University at Buffalo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University at Buffalo | Buffalo | New York | 14214 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38980666 | Derived | Castellana MC, Burnett GJ, Gasper A, Nazir MSZ, Leddy JJ, Master CL, Mannix RC, Meehan WP 3rd, Willer BS, Haider MN. Adolescents With a High Burden of New-Onset Mood Symptoms After Sport-Related Concussion Benefit From Prescribed Aerobic Exercise, a Secondary Analysis of 2 Randomized Controlled Trials. Clin J Sport Med. 2025 Jan 1;35(1):29-36. doi: 10.1097/JSM.0000000000001242. Epub 2024 Jul 9. | |
| 31377190 | Derived | Willer BS, Haider MN, Bezherano I, Wilber CG, Mannix R, Kozlowski K, Leddy JJ. Comparison of Rest to Aerobic Exercise and Placebo-like Treatment of Acute Sport-Related Concussion in Male and Female Adolescents. Arch Phys Med Rehabil. 2019 Dec;100(12):2267-2275. doi: 10.1016/j.apmr.2019.07.003. Epub 2019 Aug 1. |
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No plan to share data
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Out of 165 eligible candidates, 113 were randomized, 10 were lost to follow-up and 103 were included in the analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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.) | Posted | Median | Inter-Quartile Range | Days | 2 to 180 days |
|
From enrollment to end of follow-up, up to 30 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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Participants were not blinded to treatment; thus, intervention bias is possible. We think this unlikely, since all participants received an active intervention without being told which might be better, and they received equal attention from the investigators.We did not assess expectation of benefit (ie, perceived credibility of each intervention prior to initiation) to estimate the potential magnitude of expectancy bias.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Leddy MD | SUNY Buffalo | 7162043200 | leddy@buffalo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 24, 2016 | Sep 26, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 24, 2016 | Sep 7, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| Structured stretching prescription | Other | Participants will be given a prescription for daily stretching lasting approximately 20 minutes. |
|
| 30715132 | Derived | Leddy JJ, Haider MN, Ellis MJ, Mannix R, Darling SR, Freitas MS, Suffoletto HN, Leiter J, Cordingley DM, Willer B. Early Subthreshold Aerobic Exercise for Sport-Related Concussion: A Randomized Clinical Trial. JAMA Pediatr. 2019 Apr 1;173(4):319-325. doi: 10.1001/jamapediatrics.2018.4397. |
| Illness unrelated to study intervention |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| Time since injury | Median | Standard Deviation | Days |
|
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. |
|
|
| 0 |
| 52 |
| 0 |
| 52 |
| 0 |
| 52 |
| EG001 | 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. | 0 | 51 | 0 | 51 | 0 | 51 |
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| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D000070642 | Brain Injuries, Traumatic |
| D016489 | Head Injuries, Closed |
| D014949 | Wounds, Nonpenetrating |