Back to results

Aerobic Exercise and Cognitive Training Effects on Postconcussive Symptomology

Primary Purpose

Post-Concussion Syndrome, Post-Traumatic Headache, Post-Concussive Syndrome, Chronic

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Exercise+CT

Exercise only

About this trial

This is an interventional treatment trial for Post-Concussion Syndrome focused on measuring post-concussion, Mild Traumatic Brain Injury, head injury, headache, aerobic exercise, cognitive training, brain training, home-based intervention, social cognitive neuroscience

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

University of Illinois at Urbana-Champaign

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise+CT

Exercise only

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT03674398

First Posted

August 21, 2018

Last Updated

August 22, 2019

Sponsor

University of Illinois at Urbana-Champaign

1. Study Identification

Unique Protocol Identification Number

NCT03674398

Brief Title

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

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

October 1, 2018 (Actual)

Primary Completion Date

May 3, 2019 (Actual)

Study Completion Date

May 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Illinois at Urbana-Champaign

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Exercise+CT

Arm Type

Experimental

Arm Description

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

Arm Title

Exercise only

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Exercise+CT

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Exercise only

Intervention Description

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 Outcome Measure Information:

Title

The Rivermead Post Concussion Symptoms Questionnaire

Description

Time Frame

Assessed at baseline and at 1-month follow-up

Secondary Outcome Measure Information:

Title

NIH Toolbox Cognition Battery - Working Memory

Description

Time Frame

Assessed at baseline and at 1-month follow-up

Title

NIH Toolbox Cognition Battery - Attention

Description

Time Frame

Assessed at baseline and at 1-month follow-up

Other Pre-specified Outcome Measures:

Title

Psychosocial Battery - Mindfulness and Attention Awareness Scale (MAAS)

Description

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.

Time Frame

Assessed at baseline and 1-month follow-up

Title

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

Description

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).

Time Frame

Assessed at baseline and at 1-month follow-up

Title

Cognitive Self-Efficacy - Metamemory Questionnaire (MMQ)

Description

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.

Time Frame

Assessed at baseline and at 1-month follow-up

Title

Psychosocial Battery - Perceived Mental Fatigue (PMF)

Description

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.

Time Frame

Assessed at baseline, intra-session, and 1-month follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sean P Mullen, PhD

Organizational Affiliation

University of Illinois at Urbana-Champaign

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Daniel Palac, MA

Organizational Affiliation

University of Illinois at Urbana-Champaign

Official's Role

Study Director

Facility Information:

Facility Name

University of Illinois at Urbana-Champaign

City

Urbana

State/Province

Illinois

ZIP/Postal Code

61801

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Links:

URL

http://exercisetechlab.com

Description

Exercise, Technology, and Cognition Laboratory

Learn more about this trial

Aerobic Exercise and Cognitive Training Effects on Postconcussive Symptomology

We'll reach out to this number within 24 hrs