NCT02362347

Brief Summary

The purpose of this investigation is to determine the effect of a weighted compression vest in addition to usual medical care and exercise rehabilitation on cardiovascular, neurocognitive, balance and anxiety measures in individuals medically diagnosed with, and being treated for, a mild traumatic brain injury.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 12, 2015

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2019

Completed
Last Updated

March 6, 2019

Status Verified

March 1, 2019

Enrollment Period

4.1 years

First QC Date

February 5, 2015

Last Update Submit

March 5, 2019

Conditions

Brain ConcussionPost-Concussion Syndrome

Outcome Measures

Primary Outcomes (2)

  • Change in symptom profile

    Timeline to asymptomatic and clinical discharge

    baseline, two-weeks, three-weeks, four-weeks, 5-weeks and 6-weeks post-baseline

  • Change in exercise tolerance

    Duration and wattage achieved at symptom exacerbation

    baseline, four-weeks post-baseline, six-week post-baseline

Secondary Outcomes (6)

  • Anxiety

    baseline, two-weeks, three-weeks, four-weeks, 5-weeks and 6-weeks post-baseline

  • Balance

    baseline, two-weeks, three-weeks, four-weeks, 5-weeks and 6-weeks post-baseline

  • Transcranial Doppler Ultrasound - Cerebrovascular Function

    baseline, two-weeks, three-weeks, four-weeks, 5-weeks and 6-weeks post-baseline

  • Heart Rate Variability

    baseline, two-weeks, three-weeks, four-weeks, 5-weeks and 6-weeks post-baseline

  • Baroreflex Sensitivity

    baseline, two-weeks, three-weeks, four-weeks, 5-weeks and 6-weeks post-baseline

  • +1 more secondary outcomes

Study Arms (3)

Usual care + exercise

ACTIVE COMPARATOR

Usual care + exercise

Other: exercise

No care, no exercise

NO INTERVENTION

No care, no exercise

Usual care + exercise + compression vest

EXPERIMENTAL

Usual care + exercise + London Health Sciences Centre - Compression Vest

Device: London Health Sciences Centre - Compression VestOther: exercise

Interventions

London Health Sciences Centre - Compression VestDEVICE

London Health Sciences Centre - Compression Vest

Usual care + exercise + compression vest
exerciseOTHER

exercise

Usual care + exerciseUsual care + exercise + compression vest

Eligibility Criteria

Age12 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • concussed: medically diagnosed with, and being treated for a concussion for no longer than 1 year
  • healthy volunteer: no previous medical diagnosis of a concussion

You may not qualify if:

  • bone or muscle problems that could impact balance or how well you walk
  • diagnosis of pre-existing heart disease
  • medications that affect heart or blood vessel control
  • pre-existing brain disorders such as Parkinson's, Multiple Sclerosis, Raynaud's, Multiple System Atrophy, metabolic disorders such as diabetes, a history of significant neck injury, or focal neurologic deficit
  • primary or metastatic bone tumour
  • severe osteoporosis
  • if you are, or think you might be, pregnant or breastfeeding
  • if you are not able to be understand English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fowler Kennedy Sports Medicine Clinic

London, Ontario, N6A 3K7, Canada

Location

Neurovascular Research Laboratory

London, Ontario, N6A 3K7, Canada

Location

Related Publications (15)

  • Goldstein B, Kempski MH, DeKing D, Cox C, DeLong DJ, Kelly MM, Woolf PD. Autonomic control of heart rate after brain injury in children. Crit Care Med. 1996 Feb;24(2):234-40. doi: 10.1097/00003246-199602000-00009.

    PMID: 8605794BACKGROUND

  • Goldstein B, Toweill D, Lai S, Sonnenthal K, Kimberly B. Uncoupling of the autonomic and cardiovascular systems in acute brain injury. Am J Physiol. 1998 Oct;275(4):R1287-92. doi: 10.1152/ajpregu.1998.275.4.R1287.

    PMID: 9756562BACKGROUND

  • Griesbach GS, Gomez-Pinilla F, Hovda DA. Time window for voluntary exercise-induced increases in hippocampal neuroplasticity molecules after traumatic brain injury is severity dependent. J Neurotrauma. 2007 Jul;24(7):1161-71. doi: 10.1089/neu.2006.0255.

    PMID: 17610355BACKGROUND

  • Griesbach GS, Hovda DA, Gomez-Pinilla F. Exercise-induced improvement in cognitive performance after traumatic brain injury in rats is dependent on BDNF activation. Brain Res. 2009 Sep 8;1288:105-15. doi: 10.1016/j.brainres.2009.06.045. Epub 2009 Jun 23.

    PMID: 19555673BACKGROUND

  • Griesbach GS, Hovda DA, Molteni R, Wu A, Gomez-Pinilla F. Voluntary exercise following traumatic brain injury: brain-derived neurotrophic factor upregulation and recovery of function. Neuroscience. 2004;125(1):129-39. doi: 10.1016/j.neuroscience.2004.01.030.

    PMID: 15051152BACKGROUND

  • Junger EC, Newell DW, Grant GA, Avellino AM, Ghatan S, Douville CM, Lam AM, Aaslid R, Winn HR. Cerebral autoregulation following minor head injury. J Neurosurg. 1997 Mar;86(3):425-32. doi: 10.3171/jns.1997.86.3.0425.

    PMID: 9046298BACKGROUND

  • Kabadi SV, Faden AI. Neuroprotective strategies for traumatic brain injury: improving clinical translation. Int J Mol Sci. 2014 Jan 17;15(1):1216-36. doi: 10.3390/ijms15011216.

    PMID: 24445258BACKGROUND

  • Kiviniemi AM, Frances MF, Tiinanen S, Craen R, Rachinsky M, Petrella RJ, Seppanen T, Huikuri HV, Tulppo MP, Shoemaker JK. alpha-Adrenergic effects on low-frequency oscillations in blood pressure and R-R intervals during sympathetic activation. Exp Physiol. 2011 Aug;96(8):718-35. doi: 10.1113/expphysiol.2011.058768. Epub 2011 May 20.

    PMID: 21602293BACKGROUND

  • Kiviniemi AM, Tiinanen S, Hautala AJ, Seppanen T, Makikallio TH, Huikuri HV, Tulppo MP. Frequency of slow oscillations in arterial pressure and R-R intervals during muscle metaboreflex activation. Auton Neurosci. 2010 Jan 15;152(1-2):88-95. doi: 10.1016/j.autneu.2009.08.020. Epub 2009 Sep 19.

    PMID: 19767247BACKGROUND

  • La Fountaine MF, Heffernan KS, Gossett JD, Bauman WA, De Meersman RE. Transient suppression of heart rate complexity in concussed athletes. Auton Neurosci. 2009 Jun 15;148(1-2):101-3. doi: 10.1016/j.autneu.2009.03.001. Epub 2009 Mar 21.

    PMID: 19303821BACKGROUND

  • Len TK, Neary JP, Asmundson GJ, Candow DG, Goodman DG, Bjornson B, Bhambhani YN. Serial monitoring of CO2 reactivity following sport concussion using hypocapnia and hypercapnia. Brain Inj. 2013;27(3):346-53. doi: 10.3109/02699052.2012.743185.

    PMID: 23438354BACKGROUND

  • Papaioannou V, Giannakou M, Maglaveras N, Sofianos E, Giala M. Investigation of heart rate and blood pressure variability, baroreflex sensitivity, and approximate entropy in acute brain injury patients. J Crit Care. 2008 Sep;23(3):380-6. doi: 10.1016/j.jcrc.2007.04.006. Epub 2007 Dec 11.

    PMID: 18725044BACKGROUND

  • Piao CS, Stoica BA, Wu J, Sabirzhanov B, Zhao Z, Cabatbat R, Loane DJ, Faden AI. Late exercise reduces neuroinflammation and cognitive dysfunction after traumatic brain injury. Neurobiol Dis. 2013 Jun;54:252-63. doi: 10.1016/j.nbd.2012.12.017. Epub 2013 Jan 8.

    PMID: 23313314BACKGROUND

  • Ryan ML, Ogilvie MP, Pereira BM, Gomez-Rodriguez JC, Manning RJ, Vargas PA, Duncan RC, Proctor KG. Heart rate variability is an independent predictor of morbidity and mortality in hemodynamically stable trauma patients. J Trauma. 2011 Jun;70(6):1371-80. doi: 10.1097/TA.0b013e31821858e6.

    PMID: 21817974BACKGROUND

  • Shoemaker JK, Usselman CW, Rothwell A, Wong SW. Altered cortical activation patterns associated with baroreflex unloading following 24 h of physical deconditioning. Exp Physiol. 2012 Dec;97(12):1249-62. doi: 10.1113/expphysiol.2012.065557. Epub 2012 May 21.

    PMID: 22613740BACKGROUND

MeSH Terms

Conditions

Brain ConcussionPost-Concussion Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Kevin Shoemaker, PhD

    Western University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, PhD

Study Record Dates

First Submitted

February 5, 2015

First Posted

February 12, 2015

Study Start

February 1, 2015

Primary Completion

March 4, 2019

Study Completion

March 4, 2019

Last Updated

March 6, 2019

Record last verified: 2019-03

Locations

CA(2)