Post-acute Structured Exercise Following Sport Concussion

NCT02969824 | Terminated DMC

• 1 other identifier: 33459
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

This study will investigate the effect of structured, standardized aerobic exercise (AE) compared to usual care on clinical recovery from sport-related concussion (SRC) within the post-acute phase of injury. Participants will be randomized into one of two groups: (1) Supervised Exercise Group: participants will complete a total of eight exercise sessions over the course of 11 days, starting at Day 3 post-injury (two sessions (first and mid-point) will be done in the lab, and the remained will be home-based sessions); (2) Usual Care Group: individuals will undergo a period of physical rest and standard care. For the purposes of this study, "rest" will be defined as the avoidance of any activities beyond those of daily living, including participation in sport and physical activity.

Conditions

Concussion, Brain

Keywords

Sport Injury; Concussion; Active Recovery

Outcome Measures

Primary Outcomes (1)

• Clinical recovery - Days to Medical Clearance

  Number of days from the time of injury until a concussed athlete is cleared to return to play by a sport-medicine physician.

  Up to 1-year post-injury

Secondary Outcomes (6)

• Change in Symptoms

  28 Days: assessed at Days 7, 14, 21, 28, and 90 post-injury

• Change in Heart Rate Variability (HRV)

  28 Days: assessed at Days 7, 14, 21, 28, and 90 post-injury

• Change in Blood Pressure Variability (BPV)

  28 days: assessed at Days 7, 14, 21, 28, and 90 post-injury

• Change in Peripheral Blood Biomarkers

  28 Days: assessed at Days 7, 14, 21, 28, and 90 post-injury

• Change in Cognition

  28 Days: assessed at Days 7, 14, 21, 28, and 90 post-injury

Study Arms (2)

Usual Care Group

NO INTERVENTION

Following a brief period of physical and cognitive rest (typically1-7 days, depending on symptom severity and timing of spontaneous symptom abatement), the physician advises participants to increase their activity levels gradually with minimal head movement (predominantly involving a stationary bike) and progressively increase levels of exertion while remaining under the threshold of symptom exacerbation. Subsequently, exercise progressed to include a progression of head movements, visual and cognitive burdens, sport-specific activities, and heavy resistance, in that order, all below the symptom exacerbation threshold.

Supervised Exercise Group

EXPERIMENTAL

These individuals will begin to exercise at Day 3 post-injury. These participants will be asked to complete a total of eight exercise sessions over the course of 11 days, with one day of rest after two consecutive sessions. Two of the sessions (i.e., first and mid-point) will be an in-person exercise sessions at the lab with a member of the research team while the remaining six sessions will be home-based exercise sessions with remote communication by phone (i.e., call or text) with a member of the research team. Once individuals in this group achieve asymptomatic status, they will be directed through the existing return to play guidelines.

Behavioral: Supervised Aerobic Exercise

Interventions

Supervised Aerobic Exercise BEHAVIORAL

The AE protocol will consist of eight sessions that proceed in a stepwise fashion in terms of duration and intensity over 11 days. Exercise will be performed on the Velotron Pro stationary cycle ergometer (RacerMate Inc., WA, USA), which will be digitally connected to a heart rate monitor and programmed to monitor the wattage of the bike based on the participant's heart rate. Exercise duration (15min-20min) and intensity (60%-75% max HR) will increase over the intervention period. For the remotely supervised sessions, exercise intensities and heart rate will be monitored via FitBit.

Also known as: Exercise intervention

Supervised Exercise Group

Eligibility Criteria

• Age: 13 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosed with SRC by a physician at the David L. MacIntosh Sport Medicine Clinic
• Minimum of 13 years of age and a maximum of 25 years of age
• Able to speak and understand English

You may not qualify if:

• Have had a previous concussion within two weeks of the presenting SRC
• Have any co-morbid injuries (i.e. musculoskeletal/soft-tissue injuries, vestibular disorders)
• Have a pre-existing heart condition
• Have any uncontrolled seizure disorders or a history of medical or neurological conditions that affects cognitive functioning

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (2)

David L. MacIntosh Sport Medicine Clinic

Toronto, Ontario, M5S2C9, Canada

Location

Goldring Centre for High Performance Sport

Toronto, Ontario, M5S2C9, Canada

Location

Related Publications (17)

• McCrory P, Meeuwisse W, Aubry M, Cantu B, Dvorak J, Echemendia RJ, Engebretsen L, Johnston K, Kutcher JS, Raftery M, Sills A; Kathryn Schneider, PT, PhD, Charles H. Tator, MD, PHD; Benson BW, Davis GA, Ellenbogen RG, Guskiewicz KM, Herring SA, Iverson G, Jordan BD, Kissick J, McCrea M, McIntosh AS, Maddocks DL, Makdissi M, Purcell L, Putukian M, Turner M, Schneider K, Tator CH. Consensus statement on concussion in sport--the 4th International Conference on Concussion in Sport held in Zurich, November 2012. Clin J Sport Med. 2013 Mar;23(2):89-117. doi: 10.1097/JSM.0b013e31828b67cf. No abstract available.

  PMID: 23478784 BACKGROUND

• Silverberg ND, Iverson GL. Is rest after concussion "the best medicine?": recommendations for activity resumption following concussion in athletes, civilians, and military service members. J Head Trauma Rehabil. 2013 Jul-Aug;28(4):250-9. doi: 10.1097/HTR.0b013e31825ad658.

  PMID: 22688215 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

• Dishman RK, Berthoud HR, Booth FW, Cotman CW, Edgerton VR, Fleshner MR, Gandevia SC, Gomez-Pinilla F, Greenwood BN, Hillman CH, Kramer AF, Levin BE, Moran TH, Russo-Neustadt AA, Salamone JD, Van Hoomissen JD, Wade CE, York DA, Zigmond MJ. Neurobiology of exercise. Obesity (Silver Spring). 2006 Mar;14(3):345-56. doi: 10.1038/oby.2006.46.

  PMID: 16648603 BACKGROUND

• Marzolini S, Tang A, McIlroy W, Oh PI, Brooks D. Outcomes in people after stroke attending an adapted cardiac rehabilitation exercise program: does time from stroke make a difference? J Stroke Cerebrovasc Dis. 2014 Jul;23(6):1648-56. doi: 10.1016/j.jstrokecerebrovasdis.2014.01.008. Epub 2014 Apr 5.

  PMID: 24709146 BACKGROUND

• Teasell RW, McClure JA, Walton D, Pretty J, Salter K, Meyer M, Sequeira K, Death B. A research synthesis of therapeutic interventions for whiplash-associated disorder (WAD): part 4 - noninvasive interventions for chronic WAD. Pain Res Manag. 2010 Sep-Oct;15(5):313-22. doi: 10.1155/2010/487279.

  PMID: 21038010 BACKGROUND

• Hagen KB, Jamtvedt G, Hilde G, Winnem MF. The updated cochrane review of bed rest for low back pain and sciatica. Spine (Phila Pa 1976). 2005 Mar 1;30(5):542-6. doi: 10.1097/01.brs.0000154625.02586.95.

  PMID: 15738787 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

• Leddy JJ, Cox JL, Baker JG, Wack DS, Pendergast DR, Zivadinov R, Willer B. Exercise treatment for postconcussion syndrome: a pilot study of changes in functional magnetic resonance imaging activation, physiology, and symptoms. J Head Trauma Rehabil. 2013 Jul-Aug;28(4):241-9. doi: 10.1097/HTR.0b013e31826da964.

  PMID: 23249769 BACKGROUND

• 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

• Carson JD, Lawrence DW, Kraft SA, Garel A, Snow CL, Chatterjee A, Libfeld P, MacKenzie HM, Thornton JS, Moineddin R, Fremont P. Premature return to play and return to learn after a sport-related concussion: physician's chart review. Can Fam Physician. 2014 Jun;60(6):e310, e312-5.

  PMID: 24925965 BACKGROUND

• Williams RM, Puetz TW, Giza CC, Broglio SP. Concussion recovery time among high school and collegiate athletes: a systematic review and meta-analysis. Sports Med. 2015 Jun;45(6):893-903. doi: 10.1007/s40279-015-0325-8.

  PMID: 25820456 BACKGROUND

• Waddell G, Feder G, Lewis M. Systematic reviews of bed rest and advice to stay active for acute low back pain. Br J Gen Pract. 1997 Oct;47(423):647-52.

  PMID: 9474831 BACKGROUND

• Dahm KT, Brurberg KG, Jamtvedt G, Hagen KB. Advice to rest in bed versus advice to stay active for acute low-back pain and sciatica. Cochrane Database Syst Rev. 2010 Jun 16;2010(6):CD007612. doi: 10.1002/14651858.CD007612.pub2.

  PMID: 20556780 BACKGROUND

• Schnabel M, Ferrari R, Vassiliou T, Kaluza G. Randomised, controlled outcome study of active mobilisation compared with collar therapy for whiplash injury. Emerg Med J. 2004 May;21(3):306-10. doi: 10.1136/emj.2003.010165.

  PMID: 15107368 BACKGROUND

• Bernhardt J, Dewey H, Thrift A, Collier J, Donnan G. A very early rehabilitation trial for stroke (AVERT): phase II safety and feasibility. Stroke. 2008 Feb;39(2):390-6. doi: 10.1161/STROKEAHA.107.492363. Epub 2008 Jan 3.

  PMID: 18174489 BACKGROUND

• Hutchison MG, Di Battista AP, Lawrence DW, Pyndiura K, Corallo D, Richards D. Randomized controlled trial of early aerobic exercise following sport-related concussion: Progressive percentage of age-predicted maximal heart rate versus usual care. PLoS One. 2022 Dec 22;17(12):e0276336. doi: 10.1371/journal.pone.0276336. eCollection 2022.

  PMID: 36548338 DERIVED

MeSH Terms

Conditions

Brain Concussion

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

Study Officials

• Michael Hutchison, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Director, Concussion Program

Study Record Dates

• First Submitted: November 1, 2016
• First Posted: November 21, 2016
• Study Start: February 16, 2017
• Primary Completion: July 1, 2020
• Study Completion: September 1, 2020
• Last Updated: January 14, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)