Exercise Training in Depressed Traumatic Brain Injury Survivors

Depression Clinical Trial

Official title:

Exercise Training in Depressed Traumatic Brain Injury Survivors

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01805479
• Other study ID #: PT107574
• Secondary ID: 7K23HD067553
• Status: Withdrawn
• Phase: N/A
• First received: March 1, 2013
• Last updated: December 18, 2015
• Start date: February 2013
• Est. completion date: June 2014

Study information

• Verified date: December 2015
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Brain Injuries
• Depression
• Traumatic Brain Injury

Intervention

Other:
• aerobic exercise
the active arm will be asked to perform 60% of maximum heart rate
• stretching and flexibility program
stretching and flexibility program for the Placebo Comparator Arm

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

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Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	completion of exercise protocol	The primary aim is to measure the rate of completion of the exercise protocol.	12 weeks	No
Secondary	neuropsychological testing	cognitive testing battery will be performed to examine the impact of exercise on cognition in depressed traumatic brain injury subjects. Administered to both arms.	pre and post intervention, week zero and week 13	No
Secondary	mood assessment	depression symptom inventories will be performed to examine the impact of exercise on cognition in depressed traumatic brain injury subjects. Administered to both arms.	week 0, week 13, and weekly during 12 week intervention	No
Secondary	Columbia-Suicide Severity Rating Scale	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.	week 0, week 13, and weekly during 12 week intervention	Yes
Secondary	magnetic resonance imaging	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.	week 0, week 13	No
Secondary	biochemical assays	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.	week 0, week 13	No

External Links

•   Arhinoula A. Martinos Center for Biomedical Imaging, Charlestown, Massachusetts freely available online