Aerobic Exercise and Cognitive Training Effects on Postconcussive Symptomology
NCT ID: NCT03674398
Last Updated: 2019-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
34 participants
INTERVENTIONAL
2018-10-01
2019-05-03
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effects of Aerobic Exercise on Cognition, Mood and Fatigue Following TBI
NCT00619463
The Effect of Exercise on Neurorecovery Following Mild Traumatic Brain Injury
NCT02276079
Exercise and Rehabilitation After Traumatic Brain Injury
NCT03407924
Modulating Exercise Dosage to Improve Concussion Recovery
NCT05434130
Early Exercise to Improve Psychosocial Function After Pediatric Mild Traumatic Brain Injury
NCT04199247
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Baseline and post-intervention assessments will consist of symptom reporting, cognitive measures, and psychosocial questionnaires. Physiological measures including heart rate and blood pressure will be assessed at baseline and at follow-up as well as during each in-lab exercise session. The wait-list control group is asked to complete all baseline and follow-up assessments and resume normal activity during the four weeks. The first week of exercise will take place in a lab-based environment, while weeks 2-4 will take place outside of the lab (participants must have access to exercise equipment at home or local fitness facility).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Exercise+CT
Aerobic exercise for 30 minutes and smart-phone delivered cognitive training application for 20 minutes, 3 times per week for 4 weeks
Exercise+CT
The exercise+CT group is asked to participate in 30 minutes of aerobic exercise followed by a 20-minute cognitive training (CT) program that targets attention and memory. Training will take place following exercise due to elevated levels of brain-derived neurotrophic factor and increased arousal, which is theorized to benefit cognitive task performance. Computerized CT exercises will be delivered using participants' smartphone. Adherence to the computerized CT program is monitored using electronic data upload after each training session. Participants are asked to engage in three sessions per week with the first week taking place in a lab-setting. Participants are asked to continue the aerobic exercise and CT program at home for the subsequent three weeks.
Exercise only
Aerobic exercise for 30 minutes and smart-phone delivered videos for 20 minutes, 3 times per week for 4 weeks
Exercise only
The exercise only group will receive the same exercise prescription as the exercise+CT group. Participants in this group are asked to watch 20 minutes of health-related educational videos post-exercise. Videos are administered via participants' smartphones. After each video session, participants answer multiple-choice questions that assess engagement. Following the first week of treatment in-lab, participants are asked to continue watching health-related videos, post-exercise, for three weeks at home.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Exercise+CT
The exercise+CT group is asked to participate in 30 minutes of aerobic exercise followed by a 20-minute cognitive training (CT) program that targets attention and memory. Training will take place following exercise due to elevated levels of brain-derived neurotrophic factor and increased arousal, which is theorized to benefit cognitive task performance. Computerized CT exercises will be delivered using participants' smartphone. Adherence to the computerized CT program is monitored using electronic data upload after each training session. Participants are asked to engage in three sessions per week with the first week taking place in a lab-setting. Participants are asked to continue the aerobic exercise and CT program at home for the subsequent three weeks.
Exercise only
The exercise only group will receive the same exercise prescription as the exercise+CT group. Participants in this group are asked to watch 20 minutes of health-related educational videos post-exercise. Videos are administered via participants' smartphones. After each video session, participants answer multiple-choice questions that assess engagement. Following the first week of treatment in-lab, participants are asked to continue watching health-related videos, post-exercise, for three weeks at home.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Ability to exercise at moderate to vigorous activity levels (defined as 50%-75% of the adjusted age-predicted maximum heart rate)
* Experiencing persistent symptoms (persistent defined as, most days per week for at least 2 weeks since sustaining injury) resulting from concussion or head injury
* Access to a smartphone and willingness to allow research staff to install application (and space to allow for installation)
* Access to a treadmill to complete exercise outside of lab environment
* Willingness to provide proof of concussion or head injury medical diagnosis
* Willingness to provide contact information of individual to confirm persistent symptoms if medical diagnosis is unavailable
* Willingness to be randomized into one of three groups
Exclusion Criteria
* Experiencing less than 3 persistent symptoms (persistent defined as, most days per week for at least 2 weeks since sustaining injury)
* No access to a smartphone
* No access to a treadmill
* Too active (as defined by regular exercise most days per week for 30+ minutes over the past 3 months)
* Unable or unwilling to comply to lab and home-based exercise prescription
* Unable or unwilling to commit to full length of program
* Incapable of performing moderately intensive aerobic exercise OR sustaining attention to screen for 20 minutes
* Unwilling to be randomized to one of 3 groups
* Unable to commute to and from UIUC campus
* Already involved in regular weekly physical activity or cognitive training program
* Had previously diagnosed mental health condition (e.g., Major Depressive Disorder, Generalized Anxiety Disorder)
* Current involvement in litigation specific to injury
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Illinois at Urbana-Champaign
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sean Mullen
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sean P Mullen, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Illinois at Urbana-Champaign
Daniel Palac, MA
Role: STUDY_DIRECTOR
University of Illinois at Urbana-Champaign
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Illinois at Urbana-Champaign
Urbana, Illinois, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Exercise, Technology, and Cognition Laboratory
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
18814
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.