Trials / Completed
CompletedNCT02276079
The Effect of Exercise on Neurorecovery Following Mild Traumatic Brain Injury
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 39 (actual)
- Sponsor
- University of Florida · Academic / Other
- Sex
- All
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Accepted
Summary
The study is a "proof-of-principle" project to examine the safety and feasibility of implementing a 1-week aerobic exercise program in the post-acute phase after mild traumatic brain injury (mTBI). The study will define the extent to which the exercise program improves recovery from mTBI in terms of relevant functional outcomes (cognition, mood, and physical status) and biomarkers (peripheral brain-derived neurotrophic factor \[BDNF\] concentration).
Detailed description
This is a "proof-of-principle" project for human subjects to examine the safety and feasibility of implementing a 1-week aerobic exercise program in the post-acute phase after mild traumatic brain injury (mTBI). This study will define the extent to which the exercise program improves recovery from mTBI in terms of relevant functional outcomes (cognition, mood, and physical status) and biomarkers (peripheral brain-derived neurotrophic factor \[BDNF\] concentration). This project will also lay the foundation for understanding the relationship between exercise and BDNF in the area of mTBI neurorecovery, thereby allowing future studies to develop best-practice methods for implementing exercise interventions as a treatment option for brain injuries.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Aerobic Exercise | Aerobic exercise will consist of riding a stationary bicycle at moderate intensity for 2 consecutive, 20-minute periods with a 5-minute break in between. Moderate intensity is defined as maintaining 65-75% of estimated maximum heart rate based on the calculation (HRmax = 208 - 0.7 × age). |
| BEHAVIORAL | Non-Aerobic Exercise | Non-Aerobic exercise will consist of very low-intensity movements including static stretching and toning exercises.Participants will complete 2 consecutive, 20-minute periods with a 5-minute break in between, mirroring the aerobic exercise condition. Heart rate will be monitored by research staff to ensure that it remains below 50% of estimated maximum heart rate. |
Timeline
- Start date
- 2015-02-17
- Primary completion
- 2016-12-22
- Completion
- 2016-12-22
- First posted
- 2014-10-27
- Last updated
- 2018-12-04
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02276079. Inclusion in this directory is not an endorsement.