The Effect of a Sub-symptom Threshold Aerobic Exercise Program on Recovery in Concussed Athletes

NCT03865433 | Unknown

• 1 other identifier: ConcussionRecovery2019
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this randomized controlled trial is to examine whether systematic sub-threshold exercise is effective in improving recovery time in athletes after sport related concussion (SRC) compared to those who participate in a placebo/stretching protocol. subjects will be randomized into either an Exercise group or a Placebo/stretching group. subjects in the Exercise group will participate in an individualized exercise program supervised by their athletic trainer while the Placebo/stretching group will engage in a standardized stretching routine supervised by their athletic trainer throughout the duration of their recovery. Hypothesis 1: subjects in the aerobic Exercise group will require fewer days to recover from SRC than those who follow a placebo/stretching protocol. Hypothesis 2: heart rate threshold (HRt) achieved on the graded treadmill test will be associated with days to recovery (i.e., the lower the HRt, the longer the time to recovery). Hypothesis 3: Vestibular Ocular Motor Screen (VOMS) performance will be indicative of time to clinical recovery from concussion as evidenced by a strong correlation between VOMS score and days to clinical recovery. Hypothesis 4: Sub-threshold aerobic exercise will facilitate improvement in VOMS post-concussion. Hypothesis 5: subjects in the aerobic exercise group will demonstrate greater dynamic stability as evidenced by greater reach in each of the 3 primary directions (anterior, posterior medial and posterior lateral) for their right and left lower extremity.

Conditions

Concussion, Mild; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Time to full clinical recovery

  days between injury and return to play

  0-45 days

Secondary Outcomes (4)

• Heart rate

  Achieved HR measured and recorded on first Buffalo Concussion Treadmill Test (Week 0-baseline)-6 weeks

• Vestibular Ocular Motor Screening (VOMS)

  Recorded on first visit (Week 0-baseline)-6 weeks

• Y Balance Test (YBT) score

  Administered and recorded on the first visit (Week 0-baseline)-6 weeks

• Concussion symptom burden

  Week 0 (baseline)- 6 weeks

Study Arms (2)

Exercise Group

EXPERIMENTAL

Intervention: aerobic exercise Subjects in the exercise group will be prescribed exercise at a target heart rate (THR) of approximately 80% of the achieved heart rate during the Buffalo Concussion Treadmill Test (BCTT). They will be given this prescription in writing to provide to their athletic trainer. Subjects will complete 30 minutes of daily exercise (including 5 minutes of warm up and 5 minutes of cool down) on an exercise bike or walking and supervised by an athletic trainer. This program may be modified by increasing heart rate threshold 5-10 beats per minute per week by the athletic trainer as the heart rate for symptom exacerbation increases.

Other: Aerobic Exercise

Placebo/Stretching

PLACEBO COMPARATOR

Intrvention: stretching program Subjects assigned to the Stretching/Placebo group will be given a stretching protocol and instructions to report to their athletic trainer on a daily basis as soon as possible. . Subjects will then complete a 15-25 minute stretching program under supervision by the athletic trainer or other designated research personnel. The stretching protocol will be progressive and will change weekly as subjects continue their recovery.

Other: Placebo/Stretching

Interventions

Aerobic Exercise OTHER

Sub-symptom threshold aerobic exercise at a dose of 30 minutes per day, five days per week.

Exercise Group

Placebo/Stretching OTHER

A detailed, progressive stretching program to be performed for approximately 20-30 minutes per day, five days per week

Placebo/Stretching

Eligibility Criteria

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

You may qualify if:

• are aged 13-17, years and a high school student-athlete who attends school where an athletic trainer can supervise the exercise protocol;
• have sustained a concussion within 2-7 days of clinic presentation and diagnosed by a study physician;
• demonstrate symptom exacerbation during a graded treadmill exercise test and cannot complete the test;
• are currently participating in a school or club sport;
• are English speaking and capable of giving assent

You may not qualify if:

• have a reported history of neurological condition or disorder including but not limited to brain surgery, special education, seizure disorder, speech pathology, previous diagnosis of Post-Concussion Syndrome (PCS),
• are unwilling to exercise,
• have focal neurologic deficit that would represent risk for walking/running on treadmill,
• exhibit an inability to exercise due to injury, known heart disease, or increased cardiac risk,
• have experienced more than 3 previous concussions,
• have suffered a substantial comorbidity (eg,cervical injury),
• currently taking β-blockers, calcium channel blockers, or prophylactic headache medications (e.g., amitriptyline, topiramate), or
• have a resting blood pressure of \> 140/90.
• If the potential participant or parent/guardian is unable to fully understand the study protocol or study risks due to injury or developmental delay, the potential participant will be excluded from the study.

Sponsors & Collaborators

• Rocky Mountain University of Health Professions: lead
• Oregon Health and Science University: collaborator

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97219, United States

RECRUITING

Related Publications (13)

• McCrory P, Meeuwisse W, Dvorak J, Aubry M, Bailes J, Broglio S, Cantu RC, Cassidy D, Echemendia RJ, Castellani RJ, Davis GA, Ellenbogen R, Emery C, Engebretsen L, Feddermann-Demont N, Giza CC, Guskiewicz KM, Herring S, Iverson GL, Johnston KM, Kissick J, Kutcher J, Leddy JJ, Maddocks D, Makdissi M, Manley GT, McCrea M, Meehan WP, Nagahiro S, Patricios J, Putukian M, Schneider KJ, Sills A, Tator CH, Turner M, Vos PE. Consensus statement on concussion in sport-the 5th international conference on concussion in sport held in Berlin, October 2016. Br J Sports Med. 2017 Jun;51(11):838-847. doi: 10.1136/bjsports-2017-097699. Epub 2017 Apr 26. No abstract available.

  PMID: 28446457 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

• Thomas DG, Apps JN, Hoffmann RG, McCrea M, Hammeke T. Benefits of strict rest after acute concussion: a randomized controlled trial. Pediatrics. 2015 Feb;135(2):213-23. doi: 10.1542/peds.2014-0966. Epub 2015 Jan 5.

  PMID: 25560444 BACKGROUND

• Leddy JJ, Willer B. Use of graded exercise testing in concussion and return-to-activity management. Curr Sports Med Rep. 2013 Nov-Dec;12(6):370-6. doi: 10.1249/JSR.0000000000000008.

  PMID: 24225521 BACKGROUND

• Kurowski BG, Hugentobler J, Quatman-Yates C, Taylor J, Gubanich PJ, Altaye M, Wade SL. Aerobic Exercise for Adolescents With Prolonged Symptoms After Mild Traumatic Brain Injury: An Exploratory Randomized Clinical Trial. J Head Trauma Rehabil. 2017 Mar/Apr;32(2):79-89. doi: 10.1097/HTR.0000000000000238.

  PMID: 27120294 BACKGROUND

• Maerlender A, Rieman W, Lichtenstein J, Condiracci C. Programmed Physical Exertion in Recovery From Sports-Related Concussion: A Randomized Pilot Study. Dev Neuropsychol. 2015;40(5):273-8. doi: 10.1080/87565641.2015.1067706. Epub 2015 Jul 31.

  PMID: 26230745 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

• Buckley TA, Munkasy BA, Clouse BP. Acute Cognitive and Physical Rest May Not Improve Concussion Recovery Time. J Head Trauma Rehabil. 2016 Jul-Aug;31(4):233-41. doi: 10.1097/HTR.0000000000000165.

  PMID: 26394292 BACKGROUND

• Grool AM, Aglipay M, Momoli F, Meehan WP 3rd, Freedman SB, Yeates KO, Gravel J, Gagnon I, Boutis K, Meeuwisse W, Barrowman N, Ledoux AA, Osmond MH, Zemek R; Pediatric Emergency Research Canada (PERC) Concussion Team. Association Between Early Participation in Physical Activity Following Acute Concussion and Persistent Postconcussive Symptoms in Children and Adolescents. JAMA. 2016 Dec 20;316(23):2504-2514. doi: 10.1001/jama.2016.17396.

  PMID: 27997652 BACKGROUND

• Polak P, Leddy JJ, Dwyer MG, Willer B, Zivadinov R. Diffusion tensor imaging alterations in patients with postconcussion syndrome undergoing exercise treatment: a pilot longitudinal study. J Head Trauma Rehabil. 2015 Mar-Apr;30(2):E32-42. doi: 10.1097/HTR.0000000000000037.

  PMID: 24721808 BACKGROUND

• Baker JG, Freitas MS, Leddy JJ, Kozlowski KF, Willer BS. Return to full functioning after graded exercise assessment and progressive exercise treatment of postconcussion syndrome. Rehabil Res Pract. 2012;2012:705309. doi: 10.1155/2012/705309. Epub 2012 Jan 16.

  PMID: 22292122 BACKGROUND

• Gagnon I, Galli C, Friedman D, Grilli L, Iverson GL. Active rehabilitation for children who are slow to recover following sport-related concussion. Brain Inj. 2009 Nov;23(12):956-64. doi: 10.3109/02699050903373477.

  PMID: 19831492 BACKGROUND

• Cordingley D, Girardin R, Reimer K, Ritchie L, Leiter J, Russell K, Ellis MJ. Graded aerobic treadmill testing in pediatric sports-related concussion: safety, clinical use, and patient outcomes. J Neurosurg Pediatr. 2016 Dec;25(6):693-702. doi: 10.3171/2016.5.PEDS16139. Epub 2016 Sep 13.

  PMID: 27620871 BACKGROUND

MeSH Terms

Conditions

Brain Concussion

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Emily Kosderka, MS

  Rocky Mountain University of Health Professions

  PRINCIPAL INVESTIGATOR

• Douglas Powell, PhD

  Rocky Mountain University of Health Professions

  STUDY CHAIR

Central Study Contacts

James Chesnutt, MD

CONTACT

503-494-9992; chesnutt@ohsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Study physicians will be blinded to group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Subjects will be randomly assigned to one of two groups: the intervention group or the placebo/control group

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: March 6, 2019
• Study Start: February 27, 2019
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: August 20, 2019

Record last verified: 2019-08

Locations

US (1)