Trials / Withdrawn
WithdrawnNCT01805479
Exercise Training in Depressed Traumatic Brain Injury Survivors
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Virginia Commonwealth University · Academic / Other
- Sex
- All
- Age
- 14 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the feasibility of successfully delivering moderate intensity aerobic exercise training to depressed traumatic brain injury subjects between one and three years after injury.
Detailed description
Traumatic brain injury (TBI) alters the lives of many civilians and those involved in armed conflicts. Sequelae of TBI includes depression in up to 30% of cases. Appearance of depression after TBI impairs recovery and results in sub-optimal re-integration into society. Treatment of post TBI depression relies on oral medications, whose efficacy and side effect profile is sub-optimal. Exercise training is effective in spontaneous depression as a stand alone treatment and in conjunction with oral medications, and this may represent an alternative treatment option in the TBI population. Further, the pathophysiology of depression after TBI has yet to be examined with the full scientific rigor required. This project proposes to use exercise training of moderate intensity as a treatment for depression after TBI, while measuring biological markers as a way to investigate efficacy and provide insight into the pathophysiology.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | aerobic exercise | the active arm will be asked to perform 60% of maximum heart rate |
| OTHER | stretching and flexibility program | stretching and flexibility program for the Placebo Comparator Arm |
Timeline
- Start date
- 2013-02-01
- Primary completion
- 2014-06-01
- Completion
- 2014-06-01
- First posted
- 2013-03-06
- Last updated
- 2015-12-21
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01805479. Inclusion in this directory is not an endorsement.