INFLAME: Inflammation and Exercise
BACKGROUND:
CRP, a marker of systemic inflammation, has been reported to be an independent predictor of
cardiovascular disease in both women and men. Recently published data from cross-sectional
analyses showed that CRP is inversely related to cardiorespiratory fitness, and that this
association is independent of body mass index. Regular exercise may affect CRP levels, and
can possibly be used as a means of reducing elevated CRP levels. Though there are a number
of studies focusing on related topics, there are no published reports from randomized
clinical trials on the effect of exercise training alone on CRP levels.
DESIGN NARRATIVE:
An estimated 200 individuals will be randomly assigned to either a no exercise control group
or an exercise group. Exercising individuals will participate in 3 or 4 training sessions
each week for 4 months, and will progress to a total energy expenditure of 16 kcal [kg(-1),
week(-1)], which is an exercise dose at the upper end of current public health
recommendations for physical activity. The target exercise intensity will be 50-70% of
baseline volume of oxygen consumed (V02 max). VO2 max is the maximal rate of oxygen
consumption during exercise, and is a measurement of fitness. The primary outcome measure
will be plasma CRP concentration. Secondary outcomes will be changes in variables that are
potential mechanisms through which regular exercise might reduce CRP. These variables
include visceral adiposity, the cytokines interleukin-6 (IL-6) and tumor necrosis
factor-alpha (TNF-alpha), and heart rate variability as a measure of autonomic balance.
Although the primary outcome is CRP level, this study will also contribute significantly to
the limited body of literature examining the effect of exercise on the variables of visceral
adiposity, cytokines, and heart rate variability.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Prevention
Plasma CRP concentration (measured at Month 4)
Timothy S. Church
Principal Investigator
Pennington Biomedical Research Center
United States: Federal Government
180
NCT00113061
July 2004
June 2006
Name | Location |
---|---|
Pennington Biomedical Research Center, LSU System | Baton Rouge, Louisiana 70808 |