Exercise Training in Depressed Traumatic Brain Injury Survivors

Virginia Commonwealth University (VCU)

Status: Withdrawn

Conditions: Traumatic Brain Injury; Depression

Treatments: Other: aerobic exercise; Other: stretching and flexibility program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01805479

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

PT107574

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 14 to 65 years old

Volunteers: No 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

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

Trial design

0 participants in 2 patient groups, including a placebo group

stretching-flexibility

Placebo Comparator group

Description:

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.

Treatment:

Other: stretching and flexibility program

aerobic exercise group

Active Comparator group

Description:

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

Treatment:

Other: aerobic exercise