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

NCT ID: NCT03170856

Last Updated: 2023-01-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2021-09-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Concussion, Mild Concussion, Brain Concussion, Severe Exertion; Excess

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be randomly assigned to either the exercise intervention group or the usual care group.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise Intervention Group

Thse patients will undergo a sub-maximal exercise training as treatment for concussion.

Group Type EXPERIMENTAL

Sub-maximal exercise

Intervention Type OTHER

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 20 minutes 5times a week at 60% of their maximum heart rate or 80% of their symptom limited heart rate.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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 20 minutes 5times a week at 60% of their maximum heart rate or 80% of their symptom limited heart rate.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role collaborator

Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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William Meehan III

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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William Meehan, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

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Spaulding Rehabilitation Hospital

Cambridge, Massachusetts, United States

Site Status

Countries

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United States

References

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Howell DR, Taylor JA, Tan CO, Orr R, Meehan WP 3rd. The Role of Aerobic Exercise in Reducing Persistent Sport-related Concussion Symptoms. Med Sci Sports Exerc. 2019 Apr;51(4):647-652. doi: 10.1249/MSS.0000000000001829.

Reference Type BACKGROUND
PMID: 30376513 (View on PubMed)

Howell DR, Lugade V, Taksir M, Meehan WP 3rd. Determining the utility of a smartphone-based gait evaluation for possible use in concussion management. Phys Sportsmed. 2020 Feb;48(1):75-80. doi: 10.1080/00913847.2019.1632155. Epub 2019 Jun 26.

Reference Type BACKGROUND
PMID: 31198074 (View on PubMed)

Howell DR, Brilliant AN, Oldham JR, Berkstresser B, Wang F, Meehan WP 3rd. Exercise in the first week following concussion among collegiate athletes: Preliminary findings. J Sci Med Sport. 2020 Feb;23(2):112-117. doi: 10.1016/j.jsams.2019.08.294. Epub 2019 Sep 7.

Reference Type BACKGROUND
PMID: 31522997 (View on PubMed)

Howell DR, Oldham J, Lanois C, Koerte I, Lin AP, Berkstresser B, Wang F, Meehan WP 3rd. Dual-Task Gait Recovery after Concussion among Female and Male Collegiate Athletes. Med Sci Sports Exerc. 2020 May;52(5):1015-1021. doi: 10.1249/MSS.0000000000002225.

Reference Type BACKGROUND
PMID: 31985574 (View on PubMed)

Howell DR, Brilliant AN, Meehan WP 3rd. Tandem Gait Test-Retest Reliability Among Healthy Child and Adolescent Athletes. J Athl Train. 2019 Dec;54(12):1254-1259. doi: 10.4085/1062-6050-525-18. Epub 2019 Oct 28.

Reference Type BACKGROUND
PMID: 31657636 (View on PubMed)

Howell DR, Hunt DL, Oldham JR, Aaron SE, Meehan WP 3rd, Tan CO. Postconcussion Exercise Volume Associations With Depression, Anxiety, and Dizziness Symptoms, and Postural Stability: Preliminary Findings. J Head Trauma Rehabil. 2022 Jul-Aug 01;37(4):249-257. doi: 10.1097/HTR.0000000000000718. Epub 2021 Jul 26.

Reference Type DERIVED
PMID: 34320557 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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P00024907

Identifier Type: -

Identifier Source: org_study_id

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