Sub-Threshold Exercise Treatment for Adolescents With Sports Related Concussion

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2018-06-01

Brief Summary

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Adolescents with concussion will be randomly assigned to a treatment group where they will receive sub-threshold exercise, or assigned to a placebo group where they will receive structured stretching exercises. Both groups will receive standard medical coverage with regular clinic visits. All participants will record symptoms daily on a dedicated web site. All participants will be evaluated at time 1 with (1) structured physical exam, and (2) structured exercise stress test which is terminated when there is symptom exacerbation. The primary outcome measure is time to recovery where recovery is defined as (1) asymptomatic for two consecutive days, and (2) ability to exercise to exhaustion without exacerbation of symptoms, and (3) confirmed by a physician based on a structured physical exam.

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Detailed Description

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Adolescents with concussion will be randomly assigned to a treatment group where they will receive sub-threshold exercise, or assigned to a placebo group where they will receive structured stretching exercises. Both groups will receive standard medical coverage with regular clinic visits. All participants will record symptoms daily on a dedicated web site. All participants will be evaluated at time 1 with (1) structured physical exam, and (2) structured exercise stress test which is terminated when there is symptom exacerbation. The primary outcome measure is time to recovery where recovery is defined as (1) asymptomatic for two consecutive days, and (2) ability to exercise to exhaustion without exacerbation of symptoms, and (3) confirmed by a physician based on a structured physical exam.

Conditions

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Brain Injury Concussion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aerobic Exercise

Participants will receive an exercise prescription based on their heart rate threshold (HRT) for symptom exacerbation during the Buffalo Concussion Treadmill Test (BCTT). The script will ask the participant to exercise one a day for 20 minutes at 80% of HRT. Participants will wear a smart watch to monitor their frequency, actual time and HR during exercise. Treatment will continue until participant is fully recovered from their concussion. Intervention: Sub-Threshold exercise prescription

Group Type EXPERIMENTAL

Sub-Threshold exercise prescription

Intervention Type OTHER

Participants will be given a prescription to exercise at 80% of their threshold HR for symptom exacerbation. HR Threshold will be monitored weekly and exercise level increased accordingly.

Stretching Exercise

Participants will receive a prescription for stretching exercises that they will be asked to do daily. Participants will wear a smart watch to monitor their frequency, actual time and HR during exercise. Treatment will continue until participant is fully recovered from their concussion. Intervention: Structured stretching exercise prescription.

Group Type PLACEBO_COMPARATOR

Structured stretching prescription

Intervention Type OTHER

Participants will be given a prescription for daily stretching lasting approximately 20 minutes.

Interventions

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Sub-Threshold exercise prescription

Participants will be given a prescription to exercise at 80% of their threshold HR for symptom exacerbation. HR Threshold will be monitored weekly and exercise level increased accordingly.

Intervention Type OTHER

Structured stretching prescription

Participants will be given a prescription for daily stretching lasting approximately 20 minutes.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adolescent with concussion injury from sports within first 10 days

Exclusion Criteria

* Evidence of focal neurologic deficit; ADHD; history of moderate or severe TBI; greater than 3 prior concussions (or having history of long recovery from concussion, \>3 mths); inability to understand English

Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No