Aerobic Exercise and Cognitive Training Effects on Postconcussive Symptomology

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

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.

Study Overview

• Status: Completed
• Conditions: Acquired Brain Injury; Post-Concussion Syndrome; Head Injury; Post-Traumatic Headache; MTBI - Mild Traumatic Brain Injury; Closed Head Injury; Post-Concussive Syndrome, Chronic
• Intervention / Treatment: Behavioral: Exercise+CT; Behavioral: Exercise only

Detailed Description

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
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Urbana, Illinois, United States, 61801
      • University of Illinois at Urbana-Champaign

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise+CT; 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; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: University of Illinois at Urbana-Champaign
• Investigators: Study Director: Daniel Palac, MA, University of Illinois at Urbana-Champaign

Publications and helpful links

Helpful Links

• Exercise, Technology, and Cognition Laboratory

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): May 3, 2019
• Study Completion (Actual): May 3, 2019

Study Registration Dates

• First Submitted: August 21, 2018
• First Submitted That Met QC Criteria: September 13, 2018
• First Posted (Actual): September 17, 2018

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 22, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: aerobic exercise; head injury; cognitive training; headache; Mild Traumatic Brain Injury; brain training; post-concussion; home-based intervention; social cognitive neuroscience
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Disease; Trauma, Nervous System; Headache Disorders; Wounds, Nonpenetrating; Headache Disorders, Secondary; Syndrome; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Headache; Craniocerebral Trauma; Post-Concussion Syndrome; Brain Concussion; Post-Traumatic Headache; Head Injuries, Closed
• Other Study ID Numbers: 18814

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
• IPD Sharing Time Frame: Although this is not an NIH-funded study, we will update these records within 1 year of data collection completion per NIH guidelines.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No