Traumatic Brain Injury Clinical Trial
Official title:
Effects of Aerobic Exercise on Cognition, Mood and Fatigue Following TBI
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.
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 group. Participants 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, fatigue, and life satisfaction. Blood will be drawn 2 or 3 times
to 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.
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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