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Completed

NCT Number: NCT03674398

Aerobic Exercise and Cognitive Training Effects 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.

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Key information

Conditions

Post-Concussion Syndrome Acquired Brain Injury Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Closed Head Injury Craniocerebral Trauma Head Injuries, Closed Head Injury Headache Headache Disorders Headache Disorders, Secondary MTBI - Mild Traumatic Brain Injury Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Post-Concussive Syndrome, Chronic Post-Traumatic Headache Signs and Symptoms Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. 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.

  2. 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).

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Illinois at Urbana-Champaign

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 17, 2018
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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