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Concussion, BrainNCT02969824

Post-acute Structured Exercise Following Sport Concussion

A study testing Supervised Aerobic Exercise in people with Concussion, Brain, run by University of Toronto at 2 sites in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 13 to 25 years
Conditions the study is for
Concussion, Brain
What is being tested?
Supervised Aerobic Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
2 sitesCanada
Study dates
16 Feb 2017to 1 Sep 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • David L. MacIntosh Sport Medicine Clinic

    Toronto, Ontario, M5S2C9

  • Goldring Centre for High Performance Sport

    Toronto, Ontario, M5S2C9

Other trials in Canada

About this study

Official title: Post-acute Structured Exercise Following Sport Concussion: a Randomized Controlled Study

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.

Read the detailed description

A number of physical, cognitive, somatic, and emotional symptoms commonly occur following sports-related concussion. The most recent Concussion in Sport Consensus Statement recommends an initial period of rest (24-48 hours), followed by more activity - gradual and progressive - while staying below their cognitive and physical symptom-exacerbation thresholds. While structured exercise is advised post-injury, the appropriate intensity, frequency, and duration of activity remains unclear. Furthermore, there is also evidence that too much physical activity may be related to worse outcomes, which necessitates the investigation on the appropriate prescription of exercise following concussion.

Early work identified the potential benefit of exercise in those with persistent symptoms after concussion. However, it is important to recognize that exercise must be structured and tailored as it has been found that athletes engaging in high levels of activity post-injury were associated with greater symptom burden and poorer cognitive abilities. Collectively, these findings further support the potential benefit of personalized, prescribed exercise post-concussion.

Additional evidence in support of sub-acute and acute exercise interventions following neurological insult exists for other conditions of the central nervous system, such as low back pain, whiplash, and stroke. For example, research suggests that bed rest may actually delay recovery from acute low back pain, and recommendations to resume regular activities as soon as possible following injury result in faster recovery times, less chronic disability, and fewer recurrent problems. While rest and collar restraint were previously the standard mode of treatment for whiplash, recent evidence suggests that early mobilization and exercise compared to more traditional rest strategies. In terms of stroke, it has been shown that mobilization within 24 hours of this type of injury can expedite recovery while also inducing the risk of complications.

Therefore, the purpose of this study is to examine the effect of a structured, standardized, subacute AE intervention in adolescents after SRC, on time to recovery compared to usual care. This study will provide meaningful information regarding the utility of AE intervention after concussion. Findings from these works may inform future usual care procedures post-injury, potentially providing the first known treatment to improve recovery after concussion.

Being tested
Supervised Aerobic Exercise
Keywords
Sport Injury, Concussion, Active Recovery
Medical subject headings
Brain Concussion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Supervised Aerobic ExerciseBehavioural

    Also called Exercise intervention

    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.

Study groups in NCT02969824
Study groupRoleWhat they receive
Usual Care GroupNo interventionFollowing 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 GroupExperimentalThese 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.
Receives: Behavioral: Supervised Aerobic Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 1-year post-injury

Secondary outcomes (6)

  1. Change in Symptoms

    Concussion-related symptoms will be assessed using the Post-Concussion Symptom Scale (PCSS) of the Sport Concussion Assessment Tool-3 (SCAT3). The symptom score is comprised of a 22-item post-concussion symptom scale using a seven-point Likert scale rating. Total symptoms is the total number of symptoms with a non-zero score and symptom severity is obtained by summing the rated symptom score for each symptom.

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

  2. Change in Heart Rate Variability (HRV)

    Heart Rate Variability (HRV) will be assessed using the Polar heart rate V800 sports watch and corresponding chest strap heart monitor (Polar ®, QC, Canada). HRV will be assessed for 5 minutes in the supine position, followed by a 1-minute accommodation period, a final five-minute HRV assessment in the upright-seated position will be performed. HRV measurements to be analyzed HRV was assessed using both time domain and frequency domain measures, in accordance with recommendations of the Task Force of the European Society Cardiology and North American Society of Pacing and Electrophysiology.

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

  3. Change in Blood Pressure Variability (BPV)

    Blood Pressure Variability (BPV) will be measured using the Finapres MIDI figure cuff device concurrently with HRV. Systolic BP and diastolic BP values will be acquired throughout the acquisition period.

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

  4. Change in Peripheral Blood Biomarkers

    Peripheral blood samples (approximately 20 mL) will be drawn from participants by a trained phlebotomist. High sensitivity multiplexed immunoassay will be employed to quantitate 30 inflammatory cytokines and chemokines, and 11 central nervous-injury specific biomarkers. Individual biomarker values will be excluded if they were above or below the manufacturers' recommended level of quantitation for each analyte, or displayed a coefficient of variance >25% between duplicates. Because multiple 96-well plates will analyzed, inter-plate variance will also be accounted for; therefore, plates will only be included in the statistical analysis if the inter-plate variance was <20%, calculated from internal control samples acquired on each plate. Raw values of biomarker analyte will be used in all analyses.

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

  5. Change in Cognition

    C3 Logix (iPad platform, Cleveland, OH, USA), will be employed to measure reaction time, information processing speed, visual acuity, and postural stability. This assessment will take approximately 10-15 minutes to complete. For each of subtest, the percent correct (accuracy) and reaction time (ms) will be analyzed.

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

  6. Salivary MicroRNA and DNA Collection

    A research team member will collect a very small amount of saliva (approximately 1mL) using a swab for MicroRNA analysis, and 2ml of liquid saliva for DNA analysis. This process normally takes approximately 3 minutes.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2016 (estimated)
  2. Study start16 Feb 2017
  3. Primary completion1 Jul 2020
  4. Study completion1 Sep 2020

Why it stopped: The study was terminated prematurely due to COVID pandemic in July 2020 in Toronto, Canada. Our institution did not allow for in-person research, making continuation of the study untenable.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02969824
Sponsor's protocol ID
33459
Status last verified
Dec 2021
First submitted
1 Nov 2016
Last updated
14 Jan 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be made available to other researchers. Study data will be retained for 10 years by the principal investigator, allowing adequate time for preparation and dissemination of research findings. All electronic files will be permanently deleted at the end of the retention period. De-identified data in the collective form may be made available to other researchers within our institution before this happens in order to generate more publications from this dataset. It may obtained by the principal investigator, who will maintain this data within a password-protected network.

Publications

  • 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.

    PubMed 23478784

  • 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.

    PubMed 22688215

  • 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.

    PubMed 25560444

  • 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.

    PubMed 16648603

  • 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.

    PubMed 24709146

  • 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.

    PubMed 21038010

  • 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.

    PubMed 15738787

  • 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.

    PubMed 22292122

  • 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.

    PubMed 23249769

  • 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.

    PubMed 28446457

  • 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.

    PubMed 24925965

  • 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.

    PubMed 25820456

  • 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.

    PubMed 9474831

  • 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.

    PubMed 20556780

  • 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.

    PubMed 15107368

Questions about this trial

What is this clinical trial studying?

A study testing Supervised Aerobic Exercise in people with Concussion, Brain, run by University of Toronto at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: The study was terminated prematurely due to COVID pandemic in July 2020 in Toronto, Canada. Our institution did not allow for in-person research, making continuation of the study untenable.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical recovery - Days to Medical Clearance (time frame: Up to 1-year post-injury). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02969824, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2022.

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