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Aerobic Exercise for Concussion

Primary Purpose

Mild Traumatic Brain Injury, Acute Brain Injury, Brain Concussion

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Aerobic Exercise

Stretching Exercise

About this trial

This is an interventional treatment trial for Mild Traumatic Brain Injury focused on measuring Aerobic Exercise

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria (Case Subjects):

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.

Inclusion Criteria (Control Subjects):

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

Exclusion Criteria (Case and Control Subjects):

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.

Exclusion Criteria (Case Subjects Only):

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.

Sites / Locations

Boston Children's Hospital
University at Buffalo
Children's Hospital of Philadelphia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Aerobic Exercise

Stretching Exercise

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Time to recovery

Recovery is defined as symptom resolution, exercise tolerance, and normal clinical examination.

Secondary Outcome Measures

Persistence of post-concussive symptoms

Full Information

NCT ID

NCT02959216

First Posted

November 7, 2016

Last Updated

November 23, 2020

Sponsor

Children's Hospital of Philadelphia

Collaborators

University at Buffalo, Boston Children's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02959216

Brief Title

Aerobic Exercise for Concussion

Official Title

Sub-Symptom Aerobic Exercise Therapy to Improve Recovery From Acute Sport-Related Concussion: A Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

July 23, 2018 (Actual)

Primary Completion Date

April 1, 2020 (Actual)

Study Completion Date

July 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Children's Hospital of Philadelphia

Collaborators

University at Buffalo, Boston Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild Traumatic Brain Injury, Acute Brain Injury, Brain Concussion

Keywords

Aerobic Exercise

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care ProviderInvestigator

Allocation

Randomized

Enrollment

125 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Aerobic Exercise

Arm Type

Experimental

Arm Description

Arm Title

Stretching Exercise

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Aerobic Exercise

Intervention Description

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

Intervention Name(s)

Stretching Exercise

Intervention Description

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

Primary Outcome Measure Information:

Title

Time to recovery

Description

Recovery is defined as symptom resolution, exercise tolerance, and normal clinical examination.

Time Frame

3 to 28 days

Secondary Outcome Measure Information:

Title

Persistence of post-concussive symptoms

Time Frame

29 to 112 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria (Case Subjects): 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. Inclusion Criteria (Control Subjects): No known recent concussion within the past year or still causing active symptoms. Parental/guardian permission (informed consent) and child assent. Exclusion Criteria (Case and Control Subjects): 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. Exclusion Criteria (Case Subjects Only): 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John Leddy, MD

Organizational Affiliation

University at Buffalo

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Christina Master, MD

Organizational Affiliation

Children's Hospital of Philadelphia

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Rebekah Mannix, MD

Organizational Affiliation

Boston Children's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Boston Children's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02155

Country

United States

Facility Name

University at Buffalo

City

Buffalo

State/Province

New York

ZIP/Postal Code

14214

Country

United States

Facility Name

Children's Hospital of Philadelphia

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

24225521

Citation

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.

Results Reference

background

PubMed Identifier

26972272

Citation

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.

Results Reference

background

PubMed Identifier

20051730

Citation

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.

Results Reference

background

PubMed Identifier

29257777

Citation

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.

Results Reference

background

PubMed Identifier

35482774

Citation

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.

Results Reference

derived

PubMed Identifier

34600629

Citation

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.

Results Reference

derived

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Aerobic Exercise for Concussion

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