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

Completed · Not applicable

Conditions studied: Traumatic Brain Injury

In brief

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.

Key facts

Study ID

NCT00619463

Run by

Icahn School of Medicine at Mount Sinai

People needed

154

Starts

2007-08-01

Expected to finish

2012-10-01

Last updated by the study team

2013-09-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

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