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A Comparison Between Cardiovascular Exercise Modes Following Sport Related Concussion

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ClinicalTrials.gov Identifier: NCT04586179
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : October 14, 2020
Sponsor:
Collaborator:
University of Pittsburgh Medical Center
Information provided by (Responsible Party):
Anthony P. Kontos, Ph.D., University of Pittsburgh

Brief Summary:

Primary Aim: Compare physiological (e.g., heart rate) and clinical responses (e.g., symptom provocation) of adolescent and adult athletes (14-35 years of age) completing either a structured treadmill running or a dynamic aerobic exertion protocol during the subacute phase of sport-related concussion recovery (3-30 days after injury).

Secondary Aim: Examine potential effects of clinically-relevant factors that influence symptom responses to controlled aerobic exertion, such as age, physical activity patterns, motion sensitivities, psychological responses to injury, and sleep quality, among subjects completing controlled aerobic and dynamic exertion following sport-related concussion


Condition or disease Intervention/treatment Phase
Concussion, Mild Sport Injury Other: Aerobic (treadmill) Exercise Other: Dynamic (Agility) Exercise Not Applicable

Detailed Description:
Exercise testing is an emerging component of the clinical evaluation for sport-related concussion. Despite the growing empirical evidence to suggest that early activity following an initial rest period after injury is beneficial to recovery, the effects of modifiable exercise prescription factors (e.g., exercise mode, duration, and intensity) is unknown. Given that dynamic exertion, which incorporates synchronized head-body movements, may contribute greater information processing demands for the functional pathways responsible for balance and equilibrium than treadmill running, may be more likely to provoke symptoms during exertion. Thus, physically active (>150 min/week of moderate-intensity physical activity) participants prior to a diagnosed sport-related concussion will be randomly assigned to complete either an aerobic or dynamic exercise task at 1 study visit following injury.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Masking Description: Care provider will not be aware of group assignment; participant will be aware of intervention assessment
Primary Purpose: Diagnostic
Official Title: A Physiological and Clinical Comparison Between Cardiovascular Exercise Modes Following Sport Related Concussion
Estimated Study Start Date : October 30, 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Aerobic (treadmill) Exercise
Participants will wear a heart rate monitor and complete the Buffalo Concussion Treadmill Test
Other: Aerobic (treadmill) Exercise

Individuals begin walking at 5.8 km/hr. (3.6 mph) at a 0.0% incline (5.1 km/hr. [3.2 mph] if below 5' 10" tall), the treadmill incline is increased 1 degree each minute for the first 15 minutes, then speed increased 0.64 km/hr. (0.4 mph) each minute thereafter.

Exercise will be terminated if participant a) attains 90 percent of predicted heart rate reserve (HRR=.90*[{208-(.7*age)}-resting HR]), or b) reports a symptom worsening of 3 or points (0-10 scale) for headache, dizziness, or nausea, d) a rapid progression of complaints with continued exercise, or e) a rating of perceived exertion (RPE) greater than 18.5.


Experimental: Dynamic Exercise
Participants will wear a heart rate monitor and complete a dynamic exertion assessment that incorporates directional changes that incrementally increases in exercise intensity
Other: Dynamic (Agility) Exercise

Participants will begin in a center circle with equidistant cones 2.5 meters away. After the administrator presents a card, the participant touches a corresponding cone and returns to the starting position. Cards will be presented in increasing frequency in synchrony with a metronome application until exercise termination criteria are identified.

Exercise will be terminated if participant a) attains 90 percent of predicted heart rate reserve (HRR=.90*[{208-(.7*age)}-resting HR]), or b) reports a symptom worsening of 3 or points (0-10 scale) for headache, dizziness, or nausea, d) a rapid progression of complaints with continued exercise, or e) a rating of perceived exertion greater than 18.5.





Primary Outcome Measures :
  1. Changes in Concussion Symptoms From Pre to Post Exercise [ Time Frame: At 1 study visit within 30 days following concussion, and within 15 minutes of initiating exercise until approximately 15 minutes after exercise cessation ]
    Concussion symptoms will be measured with the Post-concussion Symptom Scale (PCSS), a patient-report survey of 22 concussion-associated symptoms on a 0-6 Likert scale (0 'none' to 6 'severe'). Number of reported symptoms (range: 0- 22) and total symptom severity (range: 0-132) whereby greater scores indicate worse symptom burden will be examined. The survey takes approximately 5 minutes to complete

  2. Heart Rate [ Time Frame: At 1 study visit within 30 days following concussion, and within 15 minutes of initiating exercise until approximately 15 minutes after exercise cessation ]
    Actual and percent of age-estimated heart rate, measured in beats per minute , will be recorded prior to (approximately 5 min), during, and following (approximately 5 min) exercise via a noninvasive heart rate monitor. Heart rate at rest, exercise cessation, and their difference (maximum heart rate - resting heart rate) will be recorded.

  3. Systolic and Diastolic Blood Pressure [ Time Frame: At 1 study visit within 30 days following concussion, and within 15 minutes of initiating exercise until approximately 15 minutes after exercise cessation ]
    Systolic and diastolic blood pressure, measured in mmHg with a non-invasive blood pressure cuff, will be recorded prior to and following exercise intervention.

  4. Exercise duration [ Time Frame: Completed during the 1 study visit within 30 days following concussion ]
    Exercise duration, the time interval between exercise initiation and cessation, will be recorded in seconds (range: 0-900)

  5. Clinical recovery [ Time Frame: Through study completion, approximately between 3 and 30 days following concussion ]
    Duration of clinical recovery, measured in days, is the interval between injury onset until medical clearance to resume unrestricted sport participation.


Secondary Outcome Measures :
  1. Changes in vestibular ocular motor screening (VOMS) symptoms from pre-exercise to post-exercise [ Time Frame: At 1 study visit within 30 days following concussion, and within 15 minutes of initiating exercise until approximately 15 minutes after exercise cessation ]
    The vestibular/ocular motor screening (VOMS) tool is a brief (approximately 5 minutes) patient-reported assessment to screen for vestibular and ocular motor impairments after concussion. Participants report on a 0-10 Likert scale (0 'none' to 10 'severe') prior to and following each of the 7 VOMS sub-tests: smooth pursuits, horizontal saccades, vertical saccades, near-point of convergence, horizontal vestibular-ocular reflex, vertical vestibular-ocular reflex, visual motion sensitivity; and near point of convergence (NPC) distance. Symptoms will be totaled across all symptoms and sub-tests (maximum=240) whereby greater scores indicate worse symptom burden.



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages 14-35
  • Prior to injury, participant fulfilled ACSM's guidelines for regular aerobic activity (30 minutes of moderate-intensity exercise 5 days per week or 20 minutes of vigorous exercise 3 days per week) prior to injury.
  • Diagnosed with a sport related concussion within 14 days of injury in the window of 3-30 days prior to completing the first study visit, and also being a single episode.
  • Participants referred to exertion therapy after a trained clinician from University of Pittsburgh Medical Center (UPMC) Sports Medicine Concussion Program has interpreted neurocognitive, vestibular, and clinical interview outcomes

Exclusion Criteria:

  • History of brain surgery or traumatic brain injury(based on Glasgow Coma Scale of <13)
  • History of neurological disorder (seizure disorder, epilepsy, brain tumors or malformations)
  • Current history of pre-existing vestibular disorder [benign paroxysmal positional vertigo (BPPV), labyrinthitis or vestibular neuritis]
  • Previous diagnosis of ocular motor condition (Ocular motor apraxia)Currently taking anticoagulant, beta-blockers, and anticonvulsant prescription medication
  • Diagnosed with a cardiac, peripheral, or cerebrovascular disease (type 1 or 2 diabetes, or renal disease.
  • Experienced chest pain or shortness of breath while at rest or with mild exertion.
  • Lose balance because of dizziness or have lost consciousness (aside from concussion) from exertion
  • Diagnosed with or taking medication for a chronic medical condition
  • Currently have a mental or physical impairment exacerbated by physical activity, leading to the inability to complete 30 minutes of moderate to vigorous exercise
  • Been told by a doctor to only conduct physical activity under medical supervision.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04586179


Contacts
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Contact: Aaron M Sinnott, MS 1412-246-0460 ams626@pitt.edu
Contact: Cynthia Holland, MPH 412-904-1298 CLH197@pitt.edu

Locations
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United States, Pennsylvania
Neuromuscular Research Laboratory-Warrior Human Performance Research Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Aaron Sinnott, MS ATC    412-246-0460    ams626@pitt.edu   
Contact: Cynthia Holland, MPH    412-904-1298    clh197@pitt.edu   
Principal Investigator: Aaron M Sinnott, MS ATC         
Sub-Investigator: Anthony P Kontos, PhD         
Sub-Investigator: Christopher Connaboy, PhD         
Sub-Investigator: Victoria Kochick, DPT PT         
Sub-Investigator: Shawn R Eagle, PhD ATC         
Sponsors and Collaborators
University of Pittsburgh
University of Pittsburgh Medical Center
Investigators
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Study Director: Anthony P Kontos, PhD UPMC Sports Medicine Concussion Program
Publications:
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Responsible Party: Anthony P. Kontos, Ph.D., Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT04586179    
Other Study ID Numbers: STUDY20010091
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Sharing Statement: Deidentified Individual participant data that underlie the current protocol will be available. Study protocol, statistical analysis plan, informed consent form, and individual participant data will be available (including data dictionary) beginning 12 months following completion of study and ending 36 months afterward. Investigators who provide a methodologically sound proposal to achieve individual participant data for meta-analyses should be directed to: https://www.nmrl.pitt.edu/ OR https://www.orthonet.pitt.edu/research/research-centers-and-labs/concussion-research-laboratory
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: 12 months following completion of study and ending 36 months afterward
Access Criteria: Investigators who provide a methodologically sound proposal to achieve individual participant data for meta-analyses
URL: http://www.orthonet.pitt.edu/research/research-centers-and-labs/concussion-research-laboratory

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anthony P. Kontos, Ph.D., University of Pittsburgh:
sport-related concussion
concussion therapy
aerobic exercise
exercise testing
Additional relevant MeSH terms:
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Brain Concussion
Athletic Injuries
Wounds and Injuries
Brain Injuries, Traumatic
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating