Exercise Training in Depressed Traumatic Brain Injury Survivors

NCT ID: NCT01805479

Last Updated: 2015-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-06-30

Brief Summary

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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

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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.

Conditions

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Depression Traumatic Brain Injury

Keywords

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exercise depression traumatic brain injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

stretching and flexibility program

Intervention Type OTHER

stretching and flexibility program for the Placebo Comparator Arm

aerobic exercise group

aerobic activity targeting 60% peak heart rate for 12 weeks is the active group.

Group Type ACTIVE_COMPARATOR

aerobic exercise

Intervention Type OTHER

the active arm will be asked to perform 60% of maximum heart rate

Interventions

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aerobic exercise

the active arm will be asked to perform 60% of maximum heart rate

Intervention Type OTHER

stretching and flexibility program

stretching and flexibility program for the Placebo Comparator Arm

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne Hudak, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Countries

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United States

References

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Related Links

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http://surfer.nmr.mgh.harvard.edu

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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

7K23HD067553

Identifier Type: NIH

Identifier Source: secondary_id

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PT107574

Identifier Type: -

Identifier Source: org_study_id