Effects of Aerobic Exercise on Cognition, Mood and Fatigue Following TBI

NCT00619463 | Completed

• 1 other identifier: 1R49CE001171-01
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine the efficacy of aerobic exercise for improving cognition, mood, and fatigue after Traumatic Brain Injury (TBI) as well as examine the role of Brain Derived Neurotropic Factor (BDNF) and peripheral Vascular Endothelial Growth Factor (VEGF) as mediators of response to exercise.

Conditions

Traumatic Brain Injury

Keywords

Traumatic Brain Injury; Exercise; Cognition; Brain Derived Neurotrophic Factor (BDNF); peripheral vascular endothelial growth factor (VEGF)

Outcome Measures

Primary Outcomes (9)

• Hopkins Verbal Learning Test-Revised (HVLT-R)

  Every 8 weeks for 24 weeks

• Trail Making Tests A and B (TMT)

  Every 8 weeks for 24 weeks

• Digit span subtests of the WAIS-III

  Every 8 weeks for 24 weeks

• Wisconsin card sort test (WCST)

  Every 8 weeks for 24 weeks

• Controlled Oral Word Association Test (COWAT)

  Every 8 weeks for 24 weeks

• Stroop Word Color Test

  Every 8 weeks for 24 weeks

• Global Fatigue Index (GFI)

  Every 8 weeks for 24 Weeks.

• Beck Depression Inventory-II ( BDI-II)

  Every 8 weeks for 24 Weeks.

• Blood draws for assessment of BDNF and VEGF levels

  Every 8 weeks for 24 weeks

Secondary Outcomes (7)

• Injury characteristics and demographic variables

  At the beginning of the study. Week 1 of 24

• BISQ - Brain Injury Screening Questionnaire

  At the beginning of the study. Week 1 of 24

• Life 3

  Every 8 weeks for 24 Weeks

• Transition Measures

  Every 8 weeks for 24 Weeks

• University of Rhode Island Change Assessment (URICA)

  Every 8 weeks for 24 Weeks

Study Arms (2)

exercise then monitor

EXPERIMENTAL

8 weeks of aerobic exercise followed by 16 weeks of monitoring

Behavioral: Exercise

monitor than exercise

EXPERIMENTAL

8 weeks of monitoring followed by 16 weeks of aerobic exercise

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

Eight weeks in an aerobic exercise program- 50 minutes of aerobic exercise on a treadmill - 3 days a week for 8 -16 weeks.

exercise then monitor

Eligibility Criteria

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

You may qualify if:

• Be 18 to 99
• Have experienced a TBI as a result of a blow to the head with a loss of consciousness or a period of being dazed and confused. This must be medically documented (e.g. EMS report, hospital record, physician record).
• Be at least six-months post-injury
• Be English-speaking since assessments and treatment sessions will be conducted by English-speaking therapists
• Have residential telephone service since follow up assessments may be completed via phone
• Live within 1.5 hours of NYC to be able to participate in baseline assessment and attend treatment sessions
• Provide written informed consent for participation
• Be willing to complete questionnaires and interviews about mood, thinking skills, fatigue, and life satisfaction
• Being willing to comply with protocol requirements and a schedule of exercise and assessments visits
• Being able to take part in a treadmill-based exercise program

You may not qualify if:

• Any medical condition in which exercising may be harmful, e.g., evidence of cardiovascular compromise including: history of acute myocardial infarction, history of coronary artery disease, unstable angina, uncontrolled hypertension, orthostatic hypotension, significant aortic valve disease, uncontrolled arrhythmia, uncompensated congestive heart failure, 3rd degree AV block without a pacemaker, active pericarditis, active myocarditis, or any evidence of pulmonary, endocrine or neurologic compromise; impaired left ventricular dysfunction; or syncopal episode within the past year
• Any medical condition requiring treatment with beta blockers or calcium channel blockers
• Under the age of 18 years of age
• Any clinically significant evidence of pulmonary, endocrine or neurologic (ataxia, gait disturbance, vertigo) compromise
• Resting pulse oxymetry of less than 95% oxygen (O2) saturation, in normal air
• Recent diagnosis of deep vein thrombosis or pulmonary embolism
• Active systemic illness or chronic infection that is not stable
• Active inflammatory process that is not stable
• Clinically significant anemia
• Clinically significant abnormal thyroid function tests
• Pregnant females
• Any reason that, in the investigator's opinion, makes the person unsuitable to participate
• Unable to physically participate in an exercise program
• Active participation in regular aerobic exercise in the six months prior to potential enrollment.
• Active substance abuse

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Centers for Disease Control and Prevention: collaborator
• U.S. Department of Education: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Wayne Gordon, Ph.D.

  Icahn School of Medicine at Mount Sinai

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2008
• First Posted: February 21, 2008
• Study Start: August 1, 2007
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: September 24, 2013

Record last verified: 2013-09

Locations

US (1)