Aerobic Exercise and Cognitive Training Effects on Postconcussive Symptomology

NCT03674398 | Completed

• 1 other identifier: 18814
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• NIH Toolbox Cognition Battery - Working Memory

  Assessed at baseline and at 1-month follow-up

• NIH Toolbox Cognition Battery - Attention

  Assessed at baseline and at 1-month follow-up

Other Outcomes (4)

• Psychosocial Battery - Mindfulness and Attention Awareness Scale (MAAS)

  Assessed at baseline and 1-month follow-up

• Psychosocial Battery - Hospital Anxiety and Depression Scale (HAD Scale)

  Assessed at baseline and at 1-month follow-up

• Cognitive Self-Efficacy - Metamemory Questionnaire (MMQ)

  Assessed at baseline and at 1-month follow-up

Study Arms (2)

Exercise+CT

EXPERIMENTAL

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

Exercise only

ACTIVE COMPARATOR

Aerobic exercise for 30 minutes and smart-phone delivered videos for 20 minutes, 3 times per week for 4 weeks

Behavioral: Exercise only

Interventions

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+CT

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.

Exercise only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead

Study Sites (1)

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

Location

Related Links

• Exercise, Technology, and Cognition Laboratory

MeSH Terms

Conditions

Post-Concussion Syndrome; Post-Traumatic Headache; Craniocerebral Trauma; Brain Concussion; Brain Injuries; Head Injuries, Closed; Headache

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Wounds, Nonpenetrating; Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Brain Injuries, Traumatic; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sean P Mullen, PhD

  University of Illinois at Urbana-Champaign

  PRINCIPAL INVESTIGATOR

• Daniel Palac, MA

  University of Illinois at Urbana-Champaign

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: September 17, 2018
• Study Start: October 1, 2018
• Primary Completion: May 3, 2019
• Study Completion: May 3, 2019
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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.
• 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.

Locations

US (1)