Clinical Trials Directory

Trials / Terminated

TerminatedNCT04586179

A Comparison Between Cardiovascular Exercise Modes Following Sport Related Concussion

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

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
6 (actual)
Sponsor
University of Pittsburgh · Academic / Other
Sex
All
Age
14 Years – 35 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERAerobic (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.
OTHERDynamic (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.

Timeline

Start date
2020-09-27
Primary completion
2021-06-03
Completion
2021-06-03
First posted
2020-10-14
Last updated
2022-05-10

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04586179. Inclusion in this directory is not an endorsement.