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Aerobic Exercise and Cognitive Training Effects on Postconcussive Symptomology

U

University of Illinois at Urbana-Champaign

Status

Completed

Conditions

Post-Concussive Syndrome, Chronic
Head Injury
Closed Head Injury
Post-Concussion Syndrome
Acquired Brain Injury
Post-Traumatic Headache
MTBI - Mild Traumatic Brain Injury

Treatments

Behavioral: Exercise only
Behavioral: Exercise+CT

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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).

Enrollment

34 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

34 participants in 2 patient groups

Exercise+CT
Experimental group
Description:
Aerobic exercise for 30 minutes and smart-phone delivered cognitive training application for 20 minutes, 3 times per week for 4 weeks
Treatment:
Behavioral: Exercise+CT
Exercise only
Active Comparator group
Description:
Aerobic exercise for 30 minutes and smart-phone delivered videos for 20 minutes, 3 times per week for 4 weeks
Treatment:
Behavioral: Exercise only

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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