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Aerobic Exercise for Concussion

NCT ID: NCT02959216

Last Updated: 2020-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-23

Study Completion Date

2020-07-07

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Mild Traumatic Brain Injury Acute Brain Injury Brain Concussion

Keywords

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Aerobic Exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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Aerobic Exercise

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.

Group Type EXPERIMENTAL

Aerobic Exercise

Intervention Type 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.

Stretching Exercise

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.

Group Type PLACEBO_COMPARATOR

Stretching Exercise

Intervention Type OTHER

Participants will be given a prescription to complete a standardized stretching protocol.

Interventions

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Aerobic Exercise

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.

Intervention Type OTHER

Stretching Exercise

Participants will be given a prescription to complete a standardized stretching protocol.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Sports-related concussion (organized or recreational).
* Physician-diagnosed concussion within the last 10 days.
* Symptom score difference ≥3 on the Post-Concussion Symptom Inventory (PCSI) Current versus PCSI Pre-Injury.
* Parental/guardian permission (informed consent) and child assent.


* No known recent concussion within the past year or still causing active symptoms.
* Parental/guardian permission (informed consent) and child assent.

Exclusion Criteria

* Subjects with moderate or severe traumatic brain injury as indicated by a score \<13 on Glasgow Coma Scale (GCS), presence of lesion on CT/MRI, and/or focal neurologic deficit consistent with an intracerebral lesion.
* History of more than 3 diagnosed concussions.
* Subjects that sustained an injury involving loss of consciousness for 30+ minutes or post-traumatic amnesia for 24+ hours.
* Inability to exercise because of lower-extremity orthopedic injury, significant vestibular or visual dysfunction, or increased cardiac risk.
* Pre-existing comorbidities, such as chronic pain, cardiac, neurological, or autoimmune conditions, that prevent participation in active testing and/or rehabilitation.
* Currently taking medications that can affect autonomic function.
* Active substance abuse/dependence.
* Unwillingness to exercise or unable to access place to safely exercise.
* Parental/guardian permission (informed consent) not obtainable or not provided
* Cannot understand English.


* Additional head injury during the intervention.
* Parents/ guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University at Buffalo

OTHER

Sponsor Role collaborator

Boston Children's Hospital

OTHER

Sponsor Role collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Leddy, MD

Role: PRINCIPAL_INVESTIGATOR

University at Buffalo

Christina Master, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Rebekah Mannix, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

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Boston Children's Hospital

Boston, Massachusetts, United States

Site Status

University at Buffalo

Buffalo, New York, United States

Site Status

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 24225521 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26972272 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20051730 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29257777 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39692552 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37015066 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35482774 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34600629 (View on PubMed)

Other Identifiers

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15-012491

Identifier Type: -

Identifier Source: org_study_id