| City: |
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New York |
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State:
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NY |
| Zip Code: |
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10029 |
| Conditions: |
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Traumatic Brain Injury |
| Purpose: |
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The purpose of the study is to determine the efficacy of aerobic exercise for improving
cognition, mood, and life satisfaction 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.
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| Study summary: |
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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 general population, represent key challenges in the rehabilitation of persons
recovering from TBI. Aerobic exercise has been shown to improve cognition and mood in the
general population. Although the positive effects of exercise have been known for some time,
only recently have some of the mechanisms underlying these effects been defined. One
hypothesized mechanism was that exercise elevates the levels of BDNF and VEGF in the CNS.
Although research examining the effects of aerobic exercise in individuals with TBI is
limited, exercise has been effective in improving cognition and depression in individuals
with other medical conditions, such as cancer, multiple sclerosis, fibromyalgia, dementia,
chronic fatigue syndrome, chronic obstructive pulmonary disease and the elderly.
The effects of aerobic exercise on patients with TBI will be examined in this clinical
trial, using a crossover design with a wait-list control. The classic crossover design has
been modified to examine the effects of an additional 8 weeks of exercise, for a total
16-week intervention, in one groupParticipants will be randomized into one of two
conditions: Group A - immediate eight weeks of intervention followed by monitoring or Group
B - monitoring followed by 8 weeks of intervention. In addition, the participants in Group B
will serve as their own controls to determine if another 8 weeks of exercise, for a total of
16 weeks, is necessary for cognitive improvement.
Each person will undergo individual interviews and testing/ questionnaires aimed at
measuring cognition, mood, participation in the community, and life satisfaction. Blood will
be drawn 2 or 3 timesto monitor BDNF and VEGF levels. Assessment of cognition, mood,
fatigue and life satisfaction will occur at four time points for both groups.
It is hypothesized that aerobic exercise will result in improved cognition and mood from
both subjective and objective perspectives. In addition, we will explore the effect of
post-TBI exercise on community participation and life satisfaction and explore personal and
injury characteristics that mediate effectiveness of aerobic exercise in individuals with
TBI. |
| Criteria: |
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Inclusion Criteria:
- 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
- Have at least a sixth grade reading level
- Provide written informed consent for participation
- Be willing to complete questionnaires and interviews about mood, thinking skills,
fatigue, community participation 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 Criteria:
- 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 |
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| Study is available at: |
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Mount Sinai School of Medicine
New York, NY 10029
United States
Primary Contact:
Wayne Gordon, Ph.D.
Email: wayne.gordon@mountsinai.org
Phone: 212-659-9372
Secondary Contact:
Katherine Gregersen
Email: Katherine.gregersen@mountsinai.org
Phone: 212-241-5152 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 22, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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