Aerobic Exercise and Cognitive Training Effects on Postconcussive Symptomology

Acquired Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03674398
• Other study ID #: 18814
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: May 3, 2019

Study information

• Verified date: August 2019
• Source: University of Illinois at Urbana-Champaign
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 3, 2019
• Est. primary completion date: May 3, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Closed Head Injury
• Craniocerebral Trauma
• Head Injuries, Closed
• Head Injury
• Headache
• MTBI - Mild Traumatic Brain Injury
• Post-Concussion Syndrome
• Post-Concussive Syndrome, Chronic
• Post-Traumatic Headache
• Syndrome
• Wounds and Injuries

Intervention

Behavioral:
• Exercise+CT
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
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.

Locations

Country	Name	City	State
United States	University of Illinois at Urbana-Champaign	Urbana	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Psychosocial Battery - Mindfulness and Attention Awareness Scale (MAAS)	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.	Assessed at baseline and 1-month follow-up
Other	Psychosocial Battery - Hospital Anxiety and Depression Scale (HAD Scale)	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).	Assessed at baseline and at 1-month follow-up
Other	Cognitive Self-Efficacy - Metamemory Questionnaire (MMQ)	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.	Assessed at baseline and at 1-month follow-up
Other	Psychosocial Battery - Perceived Mental Fatigue (PMF)	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.	Assessed at baseline, intra-session, and 1-month follow-up
Primary	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	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.	Assessed at baseline and at 1-month follow-up
Secondary	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.	Assessed at baseline and at 1-month follow-up

External Links

•   Exercise, Technology, and Cognition Laboratory