A Comparison Between Cardiovascular Exercise Modes Following Sport Related Concussion
NCT04586179 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2022-05-10
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
Interventions
- 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.
- 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.
Sponsors & Collaborators
-
University of Pittsburgh Medical Center
collaborator OTHER -
University of Pittsburgh
lead OTHER
Principal Investigators
-
Anthony P Kontos, PhD · UPMC Sports Medicine Concussion Program
Study Design
- Allocation
- RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 14 Years
- Max Age
- 35 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-09-27
- Primary Completion
- 2021-06-03
- Completion
- 2021-06-03
Countries
- United States
Study Locations
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