Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113061
Status:
COMPLETED
Last Update Posted:
2016-07-29
First Post:
2005-06-03
Brief Title:
Effect of Exercise on Elevated C-reactive Protein Concentrations in Formerly Inactive Adults
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
INFLAME Inflammation and Exercise
Status:
COMPLETED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL075442 | NIH | None | httpsreporternihgovquickSearchR01HL075442 |