Status:
COMPLETED
Effects of Aerobic Exercise on Cognition, Mood and Fatigue Following TBI
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
Centers for Disease Control and Prevention
U.S. Department of Education
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18+ years
Phase:
NA
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 Neu...
Detailed Description
The cognitive, emotional and physical effects of TBI are well documented in the literature. Specifically, reduced cognitive functioning and depression, which are much more prevalent than in the genera...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT00619463
Start Date
August 1 2007
End Date
October 1 2012
Last Update
September 24 2013
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029