- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00113061
Effect of Exercise on Elevated C-reactive Protein Concentrations in Formerly Inactive Adults
INFLAME: Inflammation and Exercise
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Louisiana
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Baton Rouge, Louisiana, Vereinigte Staaten, 70808
- Pennington Biomedical Research Center, LSU System
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
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Plasma CRP concentration (measured at Month 4)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
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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)
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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Timothy S. Church, Pennington Biomedical Research Center
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 180
- R01HL075442 (US NIH Stipendium/Vertrag)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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