Exercise Training in Depressed Traumatic Brain Injury Survivors

NCT01805479 | Withdrawn DMC

• 2 other identifiers: PT1075747K23HD067553
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Traumatic Brain Injury

Keywords

exercise; depression; traumatic brain injury

Outcome Measures

Primary Outcomes (1)

• completion of exercise protocol

  The primary aim is to measure the rate of completion of the exercise protocol.

  12 weeks

Secondary Outcomes (5)

• neuropsychological testing

  pre and post intervention, week zero and week 13

• mood assessment

  week 0, week 13, and weekly during 12 week intervention

• Columbia-Suicide Severity Rating Scale

  week 0, week 13, and weekly during 12 week intervention

• magnetic resonance imaging

  week 0, week 13

• biochemical assays

  week 0, week 13

Study Arms (2)

stretching-flexibility

PLACEBO COMPARATOR

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

aerobic exercise group

ACTIVE COMPARATOR

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

Other: aerobic exercise

Interventions

aerobic exercise OTHER

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

aerobic exercise group

stretching and flexibility program OTHER

stretching and flexibility program for the Placebo Comparator Arm

stretching-flexibility

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298-0568, United States

Location

Related Publications (129)

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Related Links

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

MeSH Terms

Conditions

Depression; Brain Injuries, Traumatic; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Anne Hudak, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2013
• First Posted: March 6, 2013
• Study Start: February 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: December 21, 2015

Record last verified: 2015-12

Locations

US (1)