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A Comparison Between Cardiovascular Exercise Modes Following Sport Related Concussion

Primary Purpose

Concussion, Mild, Sport Injury

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Aerobic (treadmill) Exercise

Dynamic (Agility) Exercise

About this trial

This is an interventional diagnostic trial for Concussion, Mild focused on measuring sport-related concussion, concussion therapy, aerobic exercise, exercise testing

Eligibility Criteria

14 Years - 35 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Neuromuscular Research Laboratory-Warrior Human Performance Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Aerobic (treadmill) Exercise

Dynamic Exercise

Arm Description

Participants will wear a heart rate monitor and complete the Buffalo Concussion Treadmill Test

Participants will wear a heart rate monitor and complete a dynamic exertion assessment that incorporates directional changes that incrementally increases in exercise intensity

Outcomes

Primary Outcome Measures

Changes in Concussion Symptoms From Pre to Post Exercise

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

Heart Rate

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.

Systolic and Diastolic Blood Pressure

Systolic and diastolic blood pressure, measured in mmHg with a non-invasive blood pressure cuff, will be recorded prior to and following exercise intervention.

Exercise duration

Exercise duration, the time interval between exercise initiation and cessation, will be recorded in seconds (range: 0-900)

Clinical recovery

Duration of clinical recovery, measured in days, is the interval between injury onset until medical clearance to resume unrestricted sport participation.

Secondary Outcome Measures

Changes in vestibular ocular motor screening (VOMS) symptoms from pre-exercise to post-exercise

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.

Full Information

NCT ID

NCT04586179

First Posted

September 29, 2020

Last Updated

May 4, 2022

Sponsor

University of Pittsburgh

Collaborators

University of Pittsburgh Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04586179

Brief Title

A Comparison Between Cardiovascular Exercise Modes Following Sport Related Concussion

Official Title

A Physiological and Clinical Comparison Between Cardiovascular Exercise Modes Following Sport Related Concussion

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Terminated

Why Stopped

Unable to enroll target number of participants.

Study Start Date

September 27, 2020 (Actual)

Primary Completion Date

June 3, 2021 (Actual)

Study Completion Date

June 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Pittsburgh

Collaborators

University of Pittsburgh Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Concussion, Mild, Sport Injury

Keywords

sport-related concussion, concussion therapy, aerobic exercise, exercise testing

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care Provider

Masking Description

Care provider will not be aware of group assignment; participant will be aware of intervention assessment

Allocation

Randomized

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Aerobic (treadmill) Exercise

Arm Type

Active Comparator

Arm Description

Participants will wear a heart rate monitor and complete the Buffalo Concussion Treadmill Test

Arm Title

Dynamic Exercise

Arm Type

Experimental

Arm Description

Participants will wear a heart rate monitor and complete a dynamic exertion assessment that incorporates directional changes that incrementally increases in exercise intensity

Intervention Type

Other

Intervention Name(s)

Aerobic (treadmill) Exercise

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Dynamic (Agility) Exercise

Intervention Description

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 Measure Information:

Title

Changes in Concussion Symptoms From Pre to Post Exercise

Description

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

Title

Heart Rate

Description

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

Title

Systolic and Diastolic Blood Pressure

Description

Systolic and diastolic blood pressure, measured in mmHg with a non-invasive blood pressure cuff, will be recorded prior to and following exercise intervention.

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

Title

Exercise duration

Description

Exercise duration, the time interval between exercise initiation and cessation, will be recorded in seconds (range: 0-900)

Time Frame

Completed during the 1 study visit within 30 days following concussion

Title

Clinical recovery

Description

Duration of clinical recovery, measured in days, is the interval between injury onset until medical clearance to resume unrestricted sport participation.

Time Frame

Through study completion, approximately between 3 and 30 days following concussion

Secondary Outcome Measure Information:

Title

Changes in vestibular ocular motor screening (VOMS) symptoms from pre-exercise to post-exercise

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anthony P Kontos, PhD

Organizational Affiliation

UPMC Sports Medicine Concussion Program

Official's Role

Study Director

Facility Information:

Facility Name

Neuromuscular Research Laboratory-Warrior Human Performance Research Center

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

IPD Sharing Time Frame

12 months following completion of study and ending 36 months afterward

IPD Sharing Access Criteria

Investigators who provide a methodologically sound proposal to achieve individual participant data for meta-analyses

IPD Sharing URL

http://www.orthonet.pitt.edu/research/research-centers-and-labs/concussion-research-laboratory

Citations:

PubMed Identifier

30439726

Citation

Orr R, Bogg T, Fyffe A, Lam LT, Browne GJ. Graded Exercise Testing Predicts Recovery Trajectory of Concussion in Children and Adolescents. Clin J Sport Med. 2021 Jan;31(1):23-30. doi: 10.1097/JSM.0000000000000683.

Results Reference

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PubMed Identifier

28570092

Citation

Lal A, Kolakowsky-Hayner SA, Ghajar J, Balamane M. The Effect of Physical Exercise After a Concussion: A Systematic Review and Meta-analysis. Am J Sports Med. 2018 Mar;46(3):743-752. doi: 10.1177/0363546517706137. Epub 2017 Jun 1.

Results Reference

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PubMed Identifier

31432081

Citation

Lumba-Brown A, Teramoto M, Bloom OJ, Brody D, Chesnutt J, Clugston JR, Collins M, Gioia G, Kontos A, Lal A, Sills A, Ghajar J. Concussion Guidelines Step 2: Evidence for Subtype Classification. Neurosurgery. 2020 Jan 1;86(1):2-13. doi: 10.1093/neuros/nyz332.

Results Reference

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A Comparison Between Cardiovascular Exercise Modes Following Sport Related Concussion

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