Effect of Exercise on Elevated C-reactive Protein Concentrations in Formerly Inactive Adults
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00113061|
Recruitment Status : Completed
First Posted : June 6, 2005
Last Update Posted : July 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases Heart Diseases Obesity||Procedure: Exercise||Not Applicable|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||162 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||INFLAME: Inflammation and Exercise|
|Study Start Date :||July 2004|
|Actual Study Completion Date :||June 2006|
- Plasma CRP concentration (measured at Month 4)
- Changes in visceral adiposity, the cytokines interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha), and heart rate variability (measured at Month 4)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00113061
|United States, Louisiana|
|Pennington Biomedical Research Center, LSU System|
|Baton Rouge, Louisiana, United States, 70808|
|Principal Investigator:||Timothy S. Church||Pennington Biomedical Research Center|