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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise+CT | Experimental | Aerobic exercise for 30 minutes and smart-phone delivered cognitive training application for 20 minutes, 3 times per week for 4 weeks |
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| Exercise only | Active Comparator | Aerobic exercise for 30 minutes and smart-phone delivered videos for 20 minutes, 3 times per week for 4 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise+CT | Behavioral | 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. |
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Psychosocial Battery - Mindfulness and Attention Awareness Scale (MAAS) | Self reported items assessing experience with meditation. Participants rate 15 items on a scale from 1-6 (1=almost always; 6=almost never) yielding a mean score across the 15 items, with higher scores indicating greater mindfulness. | Assessed at baseline and 1-month follow-up |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sean P Mullen, PhD | University of Illinois at Urbana-Champaign | Principal Investigator |
| Daniel Palac, MA | University of Illinois at Urbana-Champaign | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Urbana-Champaign | Urbana | Illinois | 61801 | United States |
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| Label | URL |
|---|---|
| Exercise, Technology, and Cognition Laboratory | View source |
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De-identified individual participant data for all primary and secondary outcome measures will be made available.
Although this is not an NIH-funded study, we will update these records within 1 year of data collection completion per NIH guidelines.
Data will be accessible on an open site (e.g., Open Science Framework https://osf.io/) with a request to interested parties to engage with the investigative team about any publication of these data in an effort to avoid redundancy. Appropriate authorship crediting investigators involved in the parent study conceptualization, and any consultation regarding data interpretation should be sought by any researchers interested in publishing these data.
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| Exercise only | Behavioral | 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. |
|
| 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 |
| Psychosocial Battery - Hospital Anxiety and Depression Scale (HAD Scale) |
Self reported items assessing anxiety and depression. Participants rate 14 items on a scale from 0-3 (0=not at all; 1=from time to time, occasionally; 2=a lot of the time; 3=most of the time) yielding a total score from 0-21. Three subscale scores are computed (non cases 0-7; doubtful cases 8-10; definite cases 11-21). |
| Assessed at baseline and at 1-month follow-up |
| Cognitive Self-Efficacy - Metamemory Questionnaire (MMQ) | Self reported items assessing emotions and perceptions about current memory abilty. Participants rate 57 items on a 5-point scale (0=strongly agree/all the time; 1=agree/often; 2=undecided/sometimes; 3=disagree/rarely; 4=strongly disagree/never), yielding three subscales (contentment, ability, and strategies). Scores are added with higher scores indicating greater contentment, ability, or strategy. | Assessed at baseline and at 1-month follow-up |
| Psychosocial Battery - Perceived Mental Fatigue (PMF) | Self-reported items assessing fatigue. Participants rate their present moment feelings on a scale from 1 - 5 (1=not true at all, 5=very true) yielding a mean score across all 7 items, with higher scores indicating greater mental fatigue. | Assessed at baseline, intra-session, and 1-month follow-up |
| ID | Term |
|---|---|
| D038223 | Post-Concussion Syndrome |
| D051298 | Post-Traumatic Headache |
| D006259 | Craniocerebral Trauma |
| D001924 | Brain Concussion |
| D001930 | Brain Injuries |
| D016489 | Head Injuries, Closed |
| D006261 | Headache |
| ID | Term |
|---|---|
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| D051271 | Headache Disorders, Secondary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D000070642 | Brain Injuries, Traumatic |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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