Concussion, MildNCT04586179
A Comparison Between Cardiovascular Exercise Modes Following Sport Related Concussion
A study testing Aerobic (treadmill) Exercise and Dynamic (Agility) Exercise in people with Concussion, Mild and Sport Injury, run by University of Pittsburgh at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 35 years
- Conditions the study is for
- Concussion, Mild, Sport Injury
- What is being tested?
- Aerobic (treadmill) Exercise and Dynamic (Agility) Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2020to 3 Jun 2021
- 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 14 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Neuromuscular Research Laboratory-Warrior Human Performance Research Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: A Physiological and Clinical Comparison Between Cardiovascular Exercise Modes Following Sport Related Concussion
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
Read the 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.
- Conditions
- Concussion, Mild, Sport Injury
- Being tested
- Aerobic (treadmill) Exercise, Dynamic (Agility) Exercise
- Keywords
- sport-related concussion, concussion therapy, aerobic exercise, exercise testing
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic (treadmill) ExerciseOther
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.
Dynamic (Agility) ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic (treadmill) Exercise | Active comparator | Participants will wear a heart rate monitor and complete the Buffalo Concussion Treadmill Test Receives: Other: Aerobic (treadmill) Exercise |
| Dynamic Exercise | Experimental | Participants will wear a heart rate monitor and complete a dynamic exertion assessment that incorporates directional changes that incrementally increases in exercise intensity Receives: Other: Dynamic (Agility) Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At 1 study visit within 30 days following concussion, and within 15 minutes of initiating exercise until approximately 15 minutes after exercise cessation
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.
Measured: 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
Systolic and diastolic blood pressure, measured in mmHg with a non-invasive blood pressure cuff, will be recorded prior to and following exercise intervention.
Measured: At 1 study visit within 30 days following concussion, and within 15 minutes of initiating exercise until approximately 15 minutes after exercise cessation
Exercise duration
Exercise duration, the time interval between exercise initiation and cessation, will be recorded in seconds (range: 0-900)
Measured: Completed during the 1 study visit within 30 days following concussion
Clinical recovery
Duration of clinical recovery, measured in days, is the interval between injury onset until medical clearance to resume unrestricted sport participation.
Measured: Through study completion, approximately between 3 and 30 days following concussion
Secondary outcomes (1)
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.
Measured: At 1 study visit within 30 days following concussion, and within 15 minutes of initiating exercise until approximately 15 minutes after exercise cessation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start27 Sep 2020
- Primary completion3 Jun 2021
- Study completion3 Jun 2021
Why it stopped: Unable to enroll target number of participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Concussion, MildStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh Medical Center
- Responsible party
- Principal investigator, Anthony P. Kontos, Ph.D., University of Pittsburgh
- Investigators
- Anthony P Kontos, PhD, Study director, UPMC Sports Medicine Concussion Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04586179
- Sponsor's protocol ID
- STUDY20010091
- Status last verified
- May 2022
- First submitted
- 29 Sep 2020
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 30439726Lal 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.
PubMed 28570092Lumba-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.
PubMed 31432081
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Physiological and Clinical Comparison Between Cardiovascular Exercise Modes Following Sport Related Concussion
- ClinicalTrials.gov ID
- NCT04586179
- Acronym / sponsor ID
- STUDY20010091
- Conditions
- Concussion, Mild, Sport Injury
- Keywords
- sport-related concussion, concussion therapy, aerobic exercise, exercise testing
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to enroll target number of participants.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- University of Pittsburgh Medical Center
- Study start
- 27 Sep 2020 (actual)
- Primary completion
- 3 Jun 2021 (actual)
- Study completion
- 3 Jun 2021 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic (treadmill) Exercise | Active comparator | Other: Aerobic (treadmill) ExerciseParticipants will wear a heart rate monitor and complete the Buffalo Concussion Treadmill Test |
| Dynamic Exercise | Experimental | Other: Dynamic (Agility) ExerciseParticipants will wear a heart rate monitor and complete a dynamic exertion assessment that incorporates directional changes that incrementally increases in exercise intensity |
Who may qualify
- Ages
- 14 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic (treadmill) ExerciseIndividuals 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. | Other | Aerobic (treadmill) Exercise |
| Dynamic (Agility) ExerciseParticipants 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. | Other | Dynamic Exercise |
Primary outcome
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
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.
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.
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)
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.
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: Unable to enroll target number of participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Background: PubMed 30439726Orr 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.
- Background: PubMed 28570092Lal 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.
- Background: PubMed 31432081Lumba-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.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony P Kontos, PhD study director
UPMC Sports Medicine Concussion Program
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic (treadmill) Exercise and Dynamic (Agility) Exercise in people with Concussion, Mild and Sport Injury, run by University of Pittsburgh at 1 site in United States.
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 4 inclusion and 10 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 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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: Unable to enroll target number of participants.). 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?
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). The study lists 5 primary outcomes in all. 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 NCT04586179, which also lists 3 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 10 May 2022; AzTrials last refreshed its copy on 6 Nov 2026.