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

NCT02459145 | Withdrawn

• 1 other identifier: PCS0001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Reduction in symptoms

  Depression Anxiety Stress Scale and ImPACT Symptom Severity Scale

  12 weeks

Secondary Outcomes (1)

• Improvement in Neuropsychological testing performance

  12 Weeks

Study Arms (2)

Graduated Exercise Protocol

ACTIVE COMPARATOR

Intervention involves exercise 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. The exercise protocol includes treadmill speed and track minutes per lap conversion, rate of perceived exertion and talk test for each stage of exercise plus total time to execute for 5 days each week.

Behavioral: Graduated exercise protocol

Rest followed by Protocol

OTHER

No activity in weeks 1 - 8. In week 9 we will begin their intervention phase as described in graduated exercise protocol

Behavioral: Graduated exercise protocol

Interventions

Graduated exercise protocol BEHAVIORAL

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.

Graduated Exercise Protocol; Rest followed by Protocol

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Between the ages of 13 and 18 (freshman - senior)
• Subject must be able to understand and sign assent form and parent/guardian must be able to understand and sign consent form
• Initial injury meets the definition of mTBI as follows:
• a. Traumatically induced physiological disruption of brain function by at least one of the following: i. Any period of loss of consciousness of 30 minutes or less ii. Any loss of memory for events immediately before or after accident and post-traumatic amnesia not greater than 24 hours iii. Any alteration in mental state at time of accident b. No structural lesions in the head or brain
• Diagnosed with post concussive syndrome as follows:
• a. Clinical SCAT-3 revised score of \>22 at 3+ weeks or plateaued score for 2 weeks or more of \>15 at 4+ weeks
• Continues to experience symptoms post injury and at time of enrollment
• Has had a normal MRI
• Can commit to participating for 12 weeks

You may not qualify if:

• Subjects who meet any of the following criteria will be excluded from study participation:
• Any documented structural lesions in the skull or brain
• Borderline TBI or concern that TBI is moderate rather than mild
• Any medication or condition that elevates heart rate

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona

Tucson, Arizona, 85724, United States

Location

Related Publications (4)

• Harmon KG, Drezner JA, Gammons M, Guskiewicz KM, Halstead M, Herring SA, Kutcher JS, Pana A, Putukian M, Roberts WO. American Medical Society for Sports Medicine position statement: concussion in sport. Br J Sports Med. 2013 Jan;47(1):15-26. doi: 10.1136/bjsports-2012-091941.

  PMID: 23243113 BACKGROUND

• Craton N, Leslie O. Is rest the best intervention for concussion? Lessons learned from the whiplash model. Curr Sports Med Rep. 2014 Jul-Aug;13(4):201-4. doi: 10.1249/JSR.0000000000000072. No abstract available.

  PMID: 25014382 BACKGROUND

• 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: 20051730 BACKGROUND

• Schneider KJ, Iverson GL, Emery CA, McCrory P, Herring SA, Meeuwisse WH. The effects of rest and treatment following sport-related concussion: a systematic review of the literature. Br J Sports Med. 2013 Apr;47(5):304-7. doi: 10.1136/bjsports-2013-092190.

  PMID: 23479489 BACKGROUND

MeSH Terms

Conditions

Post-Concussion Syndrome

Condition Hierarchy (Ancestors)

Brain Concussion; Head Injuries, Closed; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Sydney A Rice, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2015
• First Posted: June 1, 2015
• Study Start: June 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2017
• Last Updated: January 26, 2016

Record last verified: 2016-01

Locations

US (1)