Exercise Training in Depressed Traumatic Brain Injury Survivors

December 18, 2015 updated by: Virginia Commonwealth University
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298-0568
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
completion of exercise protocol
Time Frame: 12 weeks
The primary aim is to measure the rate of completion of the exercise protocol.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
pre and post intervention, week zero and week 13
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.
week 0, week 13, and weekly during 12 week intervention
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.
week 0, week 13, and weekly during 12 week intervention
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.
week 0, week 13
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.
week 0, week 13

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Collaborators

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

Investigators

  • Principal Investigator: Anne Hudak, MD, Virginia Commonwealth University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

March 1, 2013

First Submitted That Met QC Criteria

March 4, 2013

First Posted (Estimate)

March 6, 2013

Study Record Updates

Last Update Posted (Estimate)

December 21, 2015

Last Update Submitted That Met QC Criteria

December 18, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PT107574
  • 7K23HD067553 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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