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| Name | Class |
|---|---|
| University at Buffalo | OTHER |
| Boston Children's Hospital | OTHER |
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The use of aerobic exercise treatment in the chronic phase of concussion recovery is well-described in the literature but there are limited existing data on the effect of exercise treatment in the acute phase after sport-related concussion (SRC). This study will compare the outcomes of adolescents with a recent SRC who are randomized to sub-threshold aerobic exercise versus those randomized to placebo stretching to evaluate the effect of aerobic exercise in the acute recovery phase.
Historically, concussion has been described as a cognitive injury and patients have been advised not to engage in any cognitive or physical exertion while symptomatic. More recently, however, concussion has been described as a physiological injury affecting both the heart and autonomic nervous system, and patients suffering from prolonged concussion-related symptoms and deficits have been encouraged to begin aerobic exercise as part of their concussion care. While intensive exercise too soon after concussion has been associated with delayed recovery and used to justify prolonged periods of rest, recent studies have shown that controlled, sub-symptom threshold aerobic exercise may aid recovery by improving autonomic balance and cerebral blood flow auto-regulation after concussion. This study will randomly assign pediatric patients with concussion to a treatment group in which they will complete sub-symptom threshold aerobic exercise or to a placebo group in which they will complete a standardized stretching protocol. All participants will have routine visits that consist of a physical examination and exercise test until the intervention ends at recovery or 1-month post-randomization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aerobic Exercise | Experimental | Aerobic exercise participants will receive an exercise prescription based on their heart rate threshold (HRT) for symptom exacerbation during an initial treadmill test. Participants will be asked to exercise once a day up to 90% of their assigned HRT for a minimum of 20 minutes. Participants will wear a heart rate monitor to track their heart rate during aerobic exercise. The treatment will continue until the participant is recovered from his/her concussion, as determined by exercise tolerance and a normal symptom count and clinical examination. |
|
| Stretching Exercise | Placebo Comparator | Stretching exercise participants will receive a prescription to complete a standardized physical therapy stretching protocol once a day for approximately 20 minutes. Participants will wear a heart rate monitor to track their heart rate during the stretching exercise. The treatment will continue until the participant is recovered from his/her concussion, as determined by exercise tolerance and a normal symptom count and clinical examination. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerobic Exercise | Other | Participants will be given a prescription to exercise up to 90% of their threshold heart rate for symptom exacerbation. Heart rate threshold will be monitored weekly in order to increase exercise level accordingly. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to recovery | Recovery is defined as symptom resolution, exercise tolerance, and normal clinical examination. | 3 to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Persistence of post-concussive symptoms | 29 to 112 days |
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Inclusion Criteria (Case Subjects):
Inclusion Criteria (Control Subjects):
Exclusion Criteria (Case and Control Subjects):
Exclusion Criteria (Case Subjects Only):
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| Name | Affiliation | Role |
|---|---|---|
| John Leddy, MD | University at Buffalo | Principal Investigator |
| Christina Master, MD | Children's Hospital of Philadelphia | Principal Investigator |
| Rebekah Mannix, MD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02155 | United States | ||
| University at Buffalo |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24225521 | Background | Leddy JJ, Willer B. Use of graded exercise testing in concussion and return-to-activity management. Curr Sports Med Rep. 2013 Nov-Dec;12(6):370-6. doi: 10.1249/JSR.0000000000000008. | |
| 26972272 | Background | Leddy J, Hinds A, Sirica D, Willer B. The Role of Controlled Exercise in Concussion Management. PM R. 2016 Mar;8(3 Suppl):S91-S100. doi: 10.1016/j.pmrj.2015.10.017. |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D052580 | Muscle Stretching Exercises |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Stretching Exercise | Other | Participants will be given a prescription to complete a standardized stretching protocol. |
|
| Buffalo |
| New York |
| 14214 |
| United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| 20051730 | Background | Leddy JJ, Kozlowski K, Donnelly JP, Pendergast DR, Epstein LH, Willer B. A preliminary study of subsymptom threshold exercise training for refractory post-concussion syndrome. Clin J Sport Med. 2010 Jan;20(1):21-7. doi: 10.1097/JSM.0b013e3181c6c22c. |
| 29257777 | Background | Leddy JJ, Hinds AL, Miecznikowski J, Darling S, Matuszak J, Baker JG, Picano J, Willer B. Safety and Prognostic Utility of Provocative Exercise Testing in Acutely Concussed Adolescents: A Randomized Trial. Clin J Sport Med. 2018 Jan;28(1):13-20. doi: 10.1097/JSM.0000000000000431. |
| 39692552 | Derived | Stavisky CJ, Miecznikowski JC, Haider MN, Chizuk HM, Nazir MSZ, Grady MF, McPherson JI, Nowak AS, Willer BS, Master CL, Leddy JJ. Association of Cognitive Symptoms and Abnormal Oculomotor Signs With Recovery in Adolescents After Sport-Related Concussion. Clin J Sport Med. 2025 Mar 1;35(2):138-144. doi: 10.1097/JSM.0000000000001322. Epub 2024 Dec 17. |
| 39385587 | Derived | Bogdanowicz I, Plante K, Leddy J, Master C, Haider M. Quality of Life in Adolescent Athletes With Sport-Related Concussion Prescribed Heart Rate-Targeted Aerobic Exercise Within 10 Days of Injury. Clin Pediatr (Phila). 2025 Jun;64(5):631-641. doi: 10.1177/00099228241284345. Epub 2024 Oct 10. |
| 37015066 | Derived | Vernau BT, Haider MN, Fleming A, Leddy JJ, Willer BS, Storey EP, Grady MF, Mannix R, Meehan W, Master CL. Exercise-Induced Vision Dysfunction Early After Sport-Related Concussion Is Associated With Persistent Postconcussive Symptoms. Clin J Sport Med. 2023 Jul 1;33(4):388-394. doi: 10.1097/JSM.0000000000001145. Epub 2023 Mar 30. |
| 35482774 | Derived | Chizuk HM, Willer BS, Cunningham A, Bezherano I, Storey E, Master C, Mannix R, Wiebe DJ, Grady MF, Meehan WP, Leddy JJ, Haider MN. Adolescents with Sport-Related Concussion Who Adhere to Aerobic Exercise Prescriptions Recover Faster. Med Sci Sports Exerc. 2022 Sep 1;54(9):1410-1416. doi: 10.1249/MSS.0000000000002952. Epub 2022 Apr 28. |
| 34600629 | Derived | Leddy JJ, Master CL, Mannix R, Wiebe DJ, Grady MF, Meehan WP, Storey EP, Vernau BT, Brown NJ, Hunt D, Mohammed F, Mallon A, Rownd K, Arbogast KB, Cunningham A, Haider MN, Mayer AR, Willer BS. Early targeted heart rate aerobic exercise versus placebo stretching for sport-related concussion in adolescents: a randomised controlled trial. Lancet Child Adolesc Health. 2021 Nov;5(11):792-799. doi: 10.1016/S2352-4642(21)00267-4. Epub 2021 Oct 1. |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |