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The Effects of a Sub-maximal Exercise Program on Adolescents Who Sustained a Concussion

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ClinicalTrials.gov Identifier: NCT03170856
Recruitment Status : Recruiting
First Posted : May 31, 2017
Last Update Posted : October 4, 2018
Sponsor:
Collaborator:
University of Colorado, Denver
Information provided by (Responsible Party):
William Meehan III, Boston Children’s Hospital

Brief Summary:
Patients who sustain a concussion will undergo a sub-maximal exercise protocol throughout their recovery. Cerebrovascular function, heart rate, and symptom duration will be monitored throughout.

Condition or disease Intervention/treatment Phase
Concussion, Mild Concussion, Brain Concussion, Severe Exertion; Excess Other: Sub-maximal exercise Not Applicable

Detailed Description:
There has been recent change to the management of concussion, including the addition of exercise while a patient may still be experiencing symptoms. Some patients will be given a dose-dependent exercise prescription based on their own sub-maximal output. They will aerobically exercise at this given threshold for 8 weeks, while heart rate and symptom duration is tracked. Some patients will only follow physician prescribed exercise, while undergoing the same heart rate and symptom monitoring for 8 weeks.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomly assigned to either the exercise intervention group or the usual care group.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of a Sub-maximal Exercise Program on Adolescents Who Sustained a Concussion
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise Intervention Group
Thse patients will undergo a sub-maximal exercise training as treatment for concussion.
Other: Sub-maximal exercise
Subjects will participate in aerobic exercise 5 days a week. This includes walking, biking, jogging and running. While participating in these activities, they will be wearing their Polar Wrist Unit and Heart Rate Monitor to help subjects track their exercise intensity. They will exercise for 60 minutes 5times a week at 60% of their maximum heart rate or 80% of their symptom limited heart rate.

No Intervention: Usual Care Group
These patients will not undergo a sub-maximal exercise training. They will follow the exercise instructions given to them by their physician.



Primary Outcome Measures :
  1. Change in Regional Cerebral Blood Flow during exercise [ Time Frame: Measured at initial visit, 4 weeks and 8weeks to look for a change in blood flow to the brain as a person becomes asymptomatic. ]
    Using transcranial Doppler ultrasound to look at blood oxygenation levels at the prefrontal cortex during sub-maximal exercise testing.

  2. Change Concussion symptoms over the course of an exercise intervention [ Time Frame: Will be a repeated measure at the time of injury, 4 weeks and 8 weeks, to look for a change in symptom score. ]
    Measured by the Post-concussion Symptom Inventory


Secondary Outcome Measures :
  1. End-tidal CO2 [ Time Frame: Measured at initial visit, 4 weeks and 8 weeks to look for a change as a person becomes asymptomatic. ]
    Will be monitored using infrared analyzer during sub-maximal exercise testing.

  2. Heart rate [ Time Frame: Measured at initial visit, 4 weeks and 8 weeks to look for a change as a person becomes asymptomatic. ]
    Monitored via standard 3 lead ECG during sub-maximal exercise testing.

  3. Heart rate workout [ Time Frame: This will be monitored at every time point a participant exercises. 5 times a week for 8 weeks to see if their steady state heart rate increase, decreases or stays the same as they heal from their concussion. ]
    Monitored via polar watch, while the participant exercise at home based on their exercise prescription.

  4. Rate of Perceived Exhaustion [ Time Frame: Measured at initial visit, 4 weeks and 8 weeks to look for a change in perceived exhaustion as a person becomes asymptomatic ]
    Using the Borg Scale



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Ages Eligible for Study:   14 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Experienced a concussion within the last 2 weeks. Concussion will be diagnosed by board-certified sports medicine physicians, and defined as a direct or indirect blow to the head, face, neck, or elsewhere that manifests with the presence of symptoms and neurological impairment
  • Low or moderate cardiac risk according to American College of Sports Medicine
  • Post-Concussion Symptom Scale (PCSS) score greater than 9

Exclusion Criteria:

  • History of neurological surgery
  • Seizure disorder
  • Use of medication or medical device that would alter heart rate, blood pressure or autonomic function
  • Any current, serious, chronic medical or psychiatric disease that, in the Principal Investigator's judgment, may interfere with study participation or data integrity
  • Unable or unwilling to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03170856


Contacts
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Contact: David Howell, PhD 720-777-1502 ext 71502 David.Howell@UCDenver.edu
Contact: William Meehan, MD 781-216-1328 william.meehan@childrens.harvard.edu

Locations
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United States, Massachusetts
Spaulding Rehabilitation Hospital Recruiting
Cambridge, Massachusetts, United States, 02138
Contact: Can Tan, PhD       cotan@mgh.harvard.edu   
Contact: Matthew Lapointe, MS    617-758-5506    mlapointe2@partners.org   
Sponsors and Collaborators
Boston Children’s Hospital
University of Colorado, Denver

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Responsible Party: William Meehan III, MD, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT03170856     History of Changes
Other Study ID Numbers: P00024907
First Posted: May 31, 2017    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Brain Concussion
Brain Injuries, Traumatic
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds and Injuries
Wounds, Nonpenetrating