Clinical trial NCT03674398: Aerobic Exercise and Cognitive Training Effects on Postconcussive Symptomology
Official title: The Efficacy of an Aerobic Exercise and Cognitive Training Program on Postconcussive Symptomology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Concussion Syndrome
Post-Traumatic Headache
Post-Concussive Syndrome, Chronic
Head Injury
MTBI - Mild Traumatic Brain Injury
Acquired Brain Injury
Closed Head Injury
Keywords: post-concussion
Mild Traumatic Brain Injury
head injury
headache
aerobic exercise
cognitive training
brain training
home-based intervention
social cognitive neuroscience
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
First posted: 2018-09-17
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: The Rivermead Post Concussion Symptoms Questionnaire
timeFrame: Assessed at baseline and at 1-month follow-up
Secondary outcomes:
measure: NIH Toolbox Cognition Battery - Working Memory
timeFrame: Assessed at baseline and at 1-month follow-up
measure: NIH Toolbox Cognition Battery - Attention
timeFrame: Assessed at baseline and at 1-month follow-up
Other outcomes:
measure: Psychosocial Battery - Mindfulness and Attention Awareness Scale (MAAS)
timeFrame: Assessed at baseline and 1-month follow-up
measure: Psychosocial Battery - Hospital Anxiety and Depression Scale (HAD Scale)
timeFrame: Assessed at baseline and at 1-month follow-up
measure: Cognitive Self-Efficacy - Metamemory Questionnaire (MMQ)
timeFrame: Assessed at baseline and at 1-month follow-up
measure: Psychosocial Battery - Perceived Mental Fatigue (PMF)
timeFrame: Assessed at baseline, intra-session, and 1-month follow-up
Locations:
city: Urbana
country: United States
facility: University of Illinois at Urbana-Champaign
state: Illinois
Study officials:
affiliation: University of Illinois at Urbana-Champaign
name: Sean P Mullen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Illinois at Urbana-Champaign
name: Daniel Palac, MA
role: STUDY_DIRECTOR
References: