Post-Concussion Differences Between Buffalo Concussion Treadmill Test (BCTT) and Modified Dynamic Exertion (mEXiT) Test

NCT06276660 | Active Not Recruiting

• 1 other identifier: STUDY23070079
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare symptom provocation, physiologic response, and rate of perceived (RPE) between the Buffalo Concussion Treadmill Test (BCTT) and a Modified Dynamic Exertion (mEXiT) test after sport related concussion in adolescents aged 14-17. Participants will be enrolled at their initial concussion clinical visit within 14 days of their injury, and randomly assigned to either the BCTT or mEXiT group. Participants will complete a single visit.

Conditions

Mild Traumatic Brain Injury

Keywords

mtbi; concussion; exertion therapy

Outcome Measures

Primary Outcomes (2)

• Physiological response to dynamic or aerobic test (HEART RATE)

  Participants will have their heart rate taken before the exercise protocol, then monitored throughout the test and after they complete the BCTT or mEXiT.

  Visit 1 (baseline) (pre, during, and post testing) 90 minutes

• Physiological response to dynamic or aerobic test (SYMPTOM PROVOCATION)

  Participants will report on a Likert scale ranging from 0-10 (10 being severe) for headache, dizziness, and nausea, and provide a rating of perceived exertion (RPE) on a Borg scale ranging from 6 to 20 before and after completion of the BCTT or mEXiT.

  Visit 1 (baseline) (pre and post testing) 90 minutes

Secondary Outcomes (6)

• Post Concussion Symptom Scale

  Visit 1 Baseline (60-90 minutes), participants only complete one visit

• Patient Health Questionnaire (PHQ-9)

  Visit 1 Baseline (60-90 minutes), participants only complete one visit

• Generalized Anxiety Disorder (GAD-7)

  Visit 1 Baseline (60-90 minutes), participants only complete one visit

• Vestibular Ocular Motor Screening (VOMS)

  Visit 1 Baseline (pre and post testing 60-90 minutes), participants only complete one visit

• Clinical Profiles Screening (CP-Screen)

  Visit 1 Baseline (60-90 minutes), participants only complete one visit

Study Arms (2)

Buffalo Concussion Treadmill Test (BCTT)

ACTIVE COMPARATOR

Participants in this group will complete the Buffalo Concussion Treadmill Test (BCTT). This involves individuals 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.

Other: BCTT

Modified EXiT Test (mEXiT)

EXPERIMENTAL

Participants in this group will complete the modified EXiT test (mEXiT). Participants will complete a 12 minute treadmill interval program followed by a dynamic circuit (10 squat jumps, 10 side to side push ups and 10 medicine ball rotations), jump ball toss, zig zag agility and arrow agility. Parameters will be recorded the same as the established dynamic EXiT test; heart rate and RPE will be recorded at 0, 2, 6:30 and 12 minutes of the treadmill program as well as after the second trial of each activity. The time to complete two trials of the zig zag agility and arrow agility will also be recorded.

Other: Dynamic ExIT

Interventions

BCTT OTHER

Participants will complete the Buffalo Concussion Treadmill Test, which involves individuals 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.

Buffalo Concussion Treadmill Test (BCTT)

Dynamic ExIT OTHER

The modified EXiT test will complete a 12 minute treadmill interval program followed by a dynamic circuit (10 squat jumps, 10 side to side push ups and 10 medicine ball rotations), jump ball toss, zig zag agility and arrow agility. Parameters will be recorded the same as the established dynamic EXiT test; heart rate and RPE will be recorded at 0, 2, 6:30 and 12 minutes of the treadmill program as well as after the second trial of each activity. The time to complete two trials of the zig zag agility and arrow agility will also be recorded.

Modified EXiT Test (mEXiT)

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosed with a sport related concussion within 14 days of injury
• 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 and determined the participant is capable of completing structured exercise.

You may not qualify if:

• Medically cleared from a previous concussion within the past 6 months
• More than 2 previous concussions (excluding current injury)
• History of brain surgery or traumatic brain injury (TBI) (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 or oculomotor condition
• Currently taking antidepressant, anticoagulant, beta-blocker, or anticonvulsant prescription medications
• Incapable of treadmill running up to 5.5 miles per hour (mph) and 4.5 mph for males and females respectively (self-reported).
• 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
• Currently have (or have had within the past 12 months) a bone, joint, or soft tissue (muscle, ligament, or tendon) problem that could be made worse by physical activity
• Been told by a doctor to only conduct physical activity under medical supervision.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

UPMC/Univ of Pgh Sports Medicine Concussion Research Program

Pittsburgh, Pennsylvania, 15203, United States

Location

MeSH Terms

Conditions

Brain Concussion

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

Study Officials

• Anthony P Kontos, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Research Director University of Pittsburgh Concussion Lab

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 26, 2024
• Study Start: March 5, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: During and after study completion. No end date
• Access Criteria: Researchers will need to contact the study investigators and ask for access to available de-identified data.

Locations

US (1)