Exercise Training in Depressed Traumatic Brain Injury Survivors

Sponsor

Virginia Commonwealth University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01805479

Collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)

Enrollment

Location

Arms

15.9

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Depression Traumatic Brain Injury	Other: aerobic exercise Other: stretching and flexibility program	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Official Title:

Exercise Training in Depressed Traumatic Brain Injury Survivors

Study Start Date :

Feb 1, 2013

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

completion of exercise protocol [12 weeks]
The primary aim is to measure the rate of completion of the exercise protocol.

Secondary Outcome Measures

neuropsychological testing [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

CT brain with subdural hematoma, subarachnoid hemorrhage, and/or cortical contusion
Glasgow outcome scale extended of 4 to 8
speaks English
Beck Depression Inventory -II score between 14 and 28
sedentary life style
one to three years after traumatic brain injury