A Comparison Between Cardiovascular Exercise Modes Following Sport Related Concussion

NCT04586179 | Terminated

• 1 other identifier: STUDY20010091
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Conditions

Concussion, Mild; Sport Injury

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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

  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.

  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.

  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)

  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.

  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

  At 1 study visit within 30 days following concussion, and within 15 minutes of initiating exercise until approximately 15 minutes after exercise cessation

Study Arms (2)

Aerobic (treadmill) Exercise

ACTIVE COMPARATOR

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

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

Other: Dynamic (Agility) Exercise

Interventions

Aerobic (treadmill) Exercise OTHER

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.

Aerobic (treadmill) Exercise

Dynamic (Agility) Exercise OTHER

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.

Dynamic Exercise

Eligibility Criteria

• Age: 14 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• University of Pittsburgh Medical Center: collaborator

Study Sites (1)

Neuromuscular Research Laboratory-Warrior Human Performance Research Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (3)

• 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.

  PMID: 30439726 BACKGROUND

• 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.

  PMID: 28570092 BACKGROUND

• 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.

  PMID: 31432081 BACKGROUND

MeSH Terms

Conditions

Brain Concussion

Interventions

Exercise

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Anthony P Kontos, PhD

  UPMC Sports Medicine Concussion Program

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Care provider will not be aware of group assignment; participant will be aware of intervention assessment
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 14, 2020
• Study Start: September 27, 2020
• Primary Completion: June 3, 2021
• Study Completion: June 3, 2021
• Last Updated: May 10, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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

Locations

US (1)