Trials / Completed
CompletedNCT03674398
Aerobic Exercise and Cognitive Training Effects on Postconcussive Symptomology
The Efficacy of an Aerobic Exercise and Cognitive Training Program on Postconcussive Symptomology
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 34 (actual)
- Sponsor
- University of Illinois at Urbana-Champaign · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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).
Conditions
- Post-Concussion Syndrome
- Post-Traumatic Headache
- Post-Concussive Syndrome, Chronic
- Head Injury
- MTBI - Mild Traumatic Brain Injury
- Acquired Brain Injury
- Closed Head Injury
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| BEHAVIORAL | 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. |
Timeline
- Start date
- 2018-10-01
- Primary completion
- 2019-05-03
- Completion
- 2019-05-03
- First posted
- 2018-09-17
- Last updated
- 2019-08-28
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03674398. Inclusion in this directory is not an endorsement.