NCT02959216

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2016

Completed
1.7 years until next milestone

Study Start

First participant enrolled

July 23, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2020

Completed
Last Updated

November 24, 2020

Status Verified

November 1, 2020

Enrollment Period

1.7 years

First QC Date

November 7, 2016

Last Update Submit

November 23, 2020

Conditions

Mild Traumatic Brain InjuryAcute Brain InjuryBrain Concussion

Keywords

Aerobic Exercise

Outcome Measures

Primary Outcomes (1)

  • Time to recovery

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

    3 to 28 days

Secondary Outcomes (1)

  • Persistence of post-concussive symptoms

    29 to 112 days

Study Arms (2)

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.

Other: Aerobic Exercise

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.

Other: Stretching Exercise

Interventions

Aerobic ExerciseOTHER

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.

Aerobic Exercise
Stretching ExerciseOTHER

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

Stretching Exercise

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Boston Children's Hospital

Boston, Massachusetts, 02155, United States

Location

University at Buffalo

Buffalo, New York, 14214, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (8)

  • 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.

    PMID: 24225521BACKGROUND

  • 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.

    PMID: 26972272BACKGROUND

  • 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.

    PMID: 20051730BACKGROUND

  • 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.

    PMID: 29257777BACKGROUND

  • 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.

    PMID: 39692552DERIVED

  • 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.

    PMID: 37015066DERIVED

  • 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.

    PMID: 35482774DERIVED

  • 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.

    PMID: 34600629DERIVED

MeSH Terms

Conditions

Brain ConcussionBrain Injuries

Interventions

ExerciseMuscle Stretching Exercises

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2016

First Posted

November 9, 2016

Study Start

July 23, 2018

Primary Completion

April 1, 2020

Study Completion

July 7, 2020

Last Updated

November 24, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

US(3)