Aerobic Exercise and Cognitive Training Effects on Postconcussive Symptomology

Study Overview
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Brief Summary
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The purpose of this study is to compare a 4-week, moderately intensive, lab and home-based aerobic exercise program versus exercise plus cognitive training. Participants will include individuals who experience lingering symptoms of a head injury or concussion.

Detailed Description
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Eligible participants will engage in 30 minute bouts of aerobic exercise three times per week followed by a 20-minute post-exercise activity. Randomization will place participants into one of three groups: (1) aerobic exercise + cognitive training, (2) aerobic exercise + videos, or (3) waitlist control. Post-exercise activities will be delivered via participants' smartphone device by downloading the appropriate cognitive training platform or online video link. 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).

Official Title
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The Efficacy of an Aerobic Exercise and Cognitive Training Program on Postconcussive Symptomology

Conditions
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Post-Concussion Syndrome, Post-Traumatic Headache, Post-Concussive Syndrome, Chronic, Head Injury, MTBI - Mild Traumatic Brain Injury, Acquired Brain Injury, Closed Head Injury

Intervention / Treatment
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* Behavioral: Exercise+CT
* Behavioral: Exercise only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must have history of at least one concussion (onset was at age 18 or later) 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: No history of concussion, head injury, or mild traumatic brain injury 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise+CT<br>Aerobic exercise for 30 minutes and smart-phone delivered cognitive training application for 20 minutes, 3 times per week for 4 weeks | Behavioral: Exercise+CT<br>* 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.<br>|
| Active Comparator: Exercise only<br>Aerobic exercise for 30 minutes and smart-phone delivered videos for 20 minutes, 3 times per week for 4 weeks | Behavioral: Exercise only<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Rivermead Post Concussion Symptoms Questionnaire | Self reported symptoms following a head injury. Each of the 16 symptom items (e.g., sleep disturbance) is scored 0-4 (0=not experienced at all; 1=no more of a problem; 2=a mild problem; 3=a moderate problem; 4=a severe problem), yielding a total between 0 and 64. We are targeting change in total symptoms but because of the problems with change scores our operational definition of successful change in the primary outcome will be the time 2 total score (1-month follow-up) regressed on group while statistically adjusting for baseline score. | Assessed at baseline and at 1-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIH Toolbox Cognition Battery - Working Memory | List Sorting Working Memory. Participant recalls and sequences different visually and orally presented stimuli. Pictures of different foods and animals are displayed (maximum of 7 at one time) with both an accompanying audio recording and written text that name the item. Participants are asked to say the items back to the examiner in size order from smallest to largest. This test produces a standardized memory accuracy score. | Assessed at baseline and at 1-month follow-up | 
| NIH Toolbox Cognition Battery - Attention | Flanker Inhibitory Control and Attention. Participant focuses on a given stimulus while inhibiting attention to stimuli flanking it. Participants see a row of 5 arrows and choose the button that matches the direction the middle arrow is pointing. This test contains 20 items yielding a standardized accuracy and processing speed score. | Assessed at baseline and at 1-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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post-concussion, Mild Traumatic Brain Injury, head injury, headache, aerobic exercise, cognitive training, brain training, home-based intervention, social cognitive neuroscience