Exercise Training in Depressed Traumatic Brain Injury Survivors

Not Applicable

Withdrawn

• Conditions: Depression; Traumatic Brain Injury
• Interventions: Other: stretching and flexibility program; Other: aerobic exercise

• Registration Number: NCT01805479
• Lead Sponsor: Virginia Commonwealth University

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.

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 Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-03-01
• Study First Submitted QC: 2013-03-04
• Study First Posted: 2013-03-06
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-18
• Last Update Posted: 2015-12-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Exclusion Criteria

• prior history of brain process (example, stroke, brain tumor)
• aphasia
• psychosis, mania, bipolar disorder, schizophrenia
• pregnancy
• inability to exercise via cycles or treadmill

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
stretching-flexibility	stretching and flexibility program	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.
aerobic exercise group	aerobic exercise	aerobic activity targeting 60% peak heart rate for 12 weeks is the active group.

Primary Outcome Measures

Name	Time	Method
completion of exercise protocol	12 weeks	The primary aim is to measure the rate of completion of the exercise protocol.

Secondary Outcome Measures

Name	Time	Method
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.
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.
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.
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.

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States