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Assessing the Effects of a Clinical Exercise Protocol on Children With Post-concussion Syndrome

NCT02459145 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2016-01-26

No results posted yet for this study

Summary

The general consensus in sports medicine demonstrates a graduated return to activity protocol for individuals with post-concussion syndrome. This is commonly practiced but there is insufficient literature to indicate evidence-based practice. This study will provide evidence of the effectiveness of the clinical gradual return to exercise protocols beginning after diagnosis of post-concussion syndrome through standardization and measurement of outcomes.

Conditions

  • Post Concussion Syndrome

Interventions

BEHAVIORAL

Graduated exercise protocol

Intervention involves exercise protocols starting at 50% of maximum age-adjusted heart rate (MHR) for 10 minutes (warm-up and Recovery)\_ plus 5 minutes of target heart rate per day 5 days a week for 2 weeks, supervised by the athletic trainer or parent. The protocol increases the intensity of target heart rate by 10% MHR and duration of 50% MHR by 2 minutes every 2 weeks if there is no symptom exacerbation.

Sponsors & Collaborators

  • University of Arizona

    lead OTHER

Principal Investigators

  • Sydney A Rice, MD · University of Arizona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-05-31
Completion
2017-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02459145 on ClinicalTrials.gov