Status:
COMPLETED
Effect of Exercise on Elevated C-reactive Protein Concentrations in Formerly Inactive Adults
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Cardiovascular Diseases
Heart Diseases
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The purpose of this study is to determine the effect of exercise training on elevated C-reactive protein (CRP) concentrations, an indicator of inflammation, in initially inactive women and men.
Detailed Description
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 anal...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT00113061
Start Date
July 1 2004
End Date
June 1 2006
Last Update
July 29 2016
Active Locations (1)
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1
Pennington Biomedical Research Center, LSU System
Baton Rouge, Louisiana, United States, 70808