Aerobic Exercise and Cognitive Training Effects on Postconcussive Symptomology
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|ClinicalTrials.gov Identifier: NCT03674398|
Recruitment Status : Not yet recruiting
First Posted : September 17, 2018
Last Update Posted : September 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Post-Concussion Syndrome Post-Traumatic Headache Post-Concussive Syndrome, Chronic Head Injury MTBI - Mild Traumatic Brain Injury Acquired Brain Injury Closed Head Injury||Behavioral: Exercise+CT Behavioral: Exercise only||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Efficacy of an Aerobic Exercise and Cognitive Training Program on Postconcussive Symptomology|
|Estimated Study Start Date :||October 1, 2018|
|Estimated Primary Completion Date :||May 1, 2019|
|Estimated Study Completion Date :||May 1, 2019|
Aerobic exercise for 30 minutes and smart-phone delivered cognitive training application for 20 minutes, 3 times per week for 4 weeks
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.
Active Comparator: Exercise only
Aerobic exercise for 30 minutes and smart-phone delivered videos for 20 minutes, 3 times per week for 4 weeks
Behavioral: 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.
- The Rivermead Post Concussion Symptoms Questionnaire [ Time Frame: Assessed at baseline and at 1-month follow-up ]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.
- NIH Toolbox Cognition Battery - Working Memory [ Time Frame: Assessed at baseline and at 1-month follow-up ]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.
- NIH Toolbox Cognition Battery - Attention [ Time Frame: Assessed at baseline and at 1-month follow-up ]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.
- Psychosocial Battery - Mindfulness and Attention Awareness Scale (MAAS) [ Time Frame: Assessed at baseline and 1-month follow-up ]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.
- Psychosocial Battery - Hospital Anxiety and Depression Scale (HAD Scale) [ Time Frame: Assessed at baseline and at 1-month follow-up ]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).
- Cognitive Self-Efficacy - Metamemory Questionnaire (MMQ) [ Time Frame: Assessed at baseline and at 1-month follow-up ]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.
- Psychosocial Battery - Perceived Mental Fatigue (PMF) [ Time Frame: Assessed at baseline, intra-session, and 1-month follow-up ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03674398
|Contact: Sean P Mullen, PhDemail@example.com|
|Contact: Daniel Palac, MAfirstname.lastname@example.org|
|Principal Investigator:||Sean P Mullen, PhD||University of Illinois at Urbana-Champaign|
|Study Director:||Daniel Palac, MA||University of Illinois at Urbana-Champaign|