Exercise Training in Depressed Traumatic Brain Injury Survivors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01805479|
Recruitment Status : Withdrawn (Unable to enroll participants. Sponsor requested study closure.)
First Posted : March 6, 2013
Last Update Posted : December 21, 2015
|Condition or disease||Intervention/treatment||Phase|
|Depression Traumatic Brain Injury||Other: aerobic exercise Other: stretching and flexibility program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Exercise Training in Depressed Traumatic Brain Injury Survivors|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
Placebo Comparator: stretching-flexibility
This group will use a stretching and flexibility program designed to utilize minimal levels of aerobic capacity. It was chosen in place of a education-based control group due to the high level of personal interaction that is found in the active arm.
Other: stretching and flexibility program
stretching and flexibility program for the Placebo Comparator Arm
Active Comparator: aerobic exercise group
aerobic activity targeting 60% peak heart rate for 12 weeks is the active group.
Other: aerobic exercise
the active arm will be asked to perform 60% of maximum heart rate
- completion of exercise protocol [ Time Frame: 12 weeks ]The primary aim is to measure the rate of completion of the exercise protocol.
- neuropsychological testing [ Time Frame: pre and post intervention, week zero and week 13 ]cognitive testing battery will be performed to examine the impact of exercise on cognition in depressed traumatic brain injury subjects. Administered to both arms.
- mood assessment [ Time Frame: week 0, week 13, and weekly during 12 week intervention ]depression symptom inventories will be performed to examine the impact of exercise on cognition in depressed traumatic brain injury subjects. Administered to both arms.
- Columbia-Suicide Severity Rating Scale [ Time Frame: week 0, week 13, and weekly during 12 week intervention ]Columbia-Suicide Severity Rating Scale was developed to meet the need for tracking changes in a person's suicidal thinking and behavior over time, and to determine who is most at risk. Administered to both arms.
- magnetic resonance imaging [ Time Frame: week 0, week 13 ]MRI will be done before and after exercise protocol on a subset of subjects. Selection of these subjects will be done by randomization, starting once the MRI is available for use. The purpose is to examine the brain for exercise influenced volumetric changes. Administered to a subset of both arms of the study.
- biochemical assays [ Time Frame: week 0, week 13 ]brain-derived neurotrophic factor, vascular endothelial growth factor, insulin-like growth factor-1. The listed neurotrophic factors have been linked to depression and have been shown to be influenced by exercise. The impact of depression and exercise in the context of traumatic brain injury is unknown. Administered to both study arms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01805479
|United States, Virginia|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298-0568|
|Principal Investigator:||Anne Hudak, MD||Virginia Commonwealth University|