INFLAME: Inflammation and Exercise
18 Years
75 Years
Both
Cardiovascular Diseases, Heart Diseases, Obesity
Trial Information
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.
Inclusion Criteria:
- Physically inactive
- C-reactive protein level at least 2.0 mg/L but less than 10.0 mg/L upon study entry
- Body mass index between 18.5 kg/square meter and 40.0 kg/square meter as measured at
study entry
- Does not smoke
- Total cholesterol at least 240 mg/dl with LDL-C at least 160 mg/dl OR LDL less than
190 mg/dl and Framingham less than 10%
- Triglyceride levels no higher than 300 mg/dl
- Fasting glucose level less than 126
- Systolic blood pressure less than 140 mm Hg and/or diastolic blood pressure less than
90 mm Hg as measured at study entry
- If taking an oral contraceptive, aspirin, ibuprofen, or other anti-inflammatory
medications, must be on a stable dose for 6 months prior to study entry
- If taking a cholesterol medication, including statins, blood pressure medication
(including ace inhibitors), or multi-vitamins, must be on a stable dose for 2 months
prior to study entry
Exclusion Criteria:
- Using a beta blocker, hormone replacement therapy, or corticosteroids (except
inhalers)
- Any rheumatologic, orthopedic, neurological, or autoimmune diseases, or seizure
disorder
- Any significant cardiovascular disease or disorders including, but not limited to,
stent or coronary artery bypass grafting
- Cardiac dysrhythmias including, but not limited to, left bundle branch block, atrial
fibrillation, pacemaker, or automatic implantable cardioverter defibrillator
- Any surgery, broken bones, blood donation, or anaphylactic shock within 6 months of
study entry
- Any sprain or strain, removal of wisdom teeth, or use of antibiotics within 3 months
of study entry
- History of stroke or TIA
- History of cancer within at least 5 years of study entry
- Diabetes or glucose intolerance
- Planning on participating in any other research trials during the next year
- Currently pregnant
- Planning to becoming pregnant during the next year
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Prevention
Outcome Measure:
Plasma CRP concentration (measured at Month 4)
Principal Investigator
Timothy S. Church
Investigator Role:
Principal Investigator
Investigator Affiliation:
Pennington Biomedical Research Center
Authority:
United States: Federal Government
Study ID:
180
NCT ID:
NCT00113061
Start Date:
July 2004
Completion Date:
June 2006
Related Keywords:
- Cardiovascular Diseases
- Heart Diseases
- Obesity
- Coronary Heart Disease Risk Reduction
- Cardiovascular Diseases
- Heart Diseases
- Obesity
Name | Location |
|---|---|
| Pennington Biomedical Research Center, LSU System | Baton Rouge, Louisiana 70808 |
