Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00246883
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2005-10-29
Brief Title:
Effect of Regular Exercise on Vascular Function and Cardiovascular Risk in a Sedentary Work Force
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Effect of Regular Exercise on Vascular Function and Cardiovascular Risk in a Sedentary Work Force The NHLBI Keep the Beat Program
Status:
COMPLETED
Status Verified Date:
2009-04-15
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:
This study will evaluate the effects of NHLBIs employee exercise program Keep the Beat on blood vessel function Damage to blood vessels can cause narrowing of the vessels resulting in reduced blood flow to parts of the body such as the heart Stem cells called endothelial progenitor cells or EPCs may be able to heal blood vessel damage Exercise such as walking on a treadmill can help move EPCs from the bone marrow where they originate into the blood stream to help heal the damaged blood vessels The Keep the Beat program encourages NHLBI employees to exercise 15 minutes during the workday and provides exercise facilities to accomplish this
NHLBI employees who have access to NIH exercise facilities may be eligible for this study Candidates must have no history of heart disease must not currently be exercising more than 15 hours per week and must not have participated in the Keep the Beat program for 3 months prior to entering the study They are screened with blood tests and blood pressure measurements
Participants undergo the following tests and procedures before beginning the study and 3 months after participating in Keep the Beat
Blood tests to identify EPCs and their function measure the level of nitric oxide a gas produced by healthy blood vessels and measure C-reactive protein an inflammatory marker that may be a risk factor for cardiovascular disease
Brachial artery reactivity study to measure how well the arteries widen An ultrasound device is placed over the subjects artery just above the elbow The device measures the size of the artery and the flow of blood through it before and after a pressure cuff is inflated around the forearm
Treadmill exercise testing to evaluate physical fitness Subjects exercise on a treadmill for as long as they can An exercise specialist is present throughout the test Heart rhythm and oxygen saturation are monitored continuously and blood pressure is measured every 3 minutes
NHLBI employees who have access to NIH exercise facilities may be eligible for this study Candidates must have no history of heart disease must not currently be exercising more than 15 hours per week and must not have participated in the Keep the Beat program for 3 months prior to entering the study They are screened with blood tests and blood pressure measurements
Participants undergo the following tests and procedures before beginning the study and 3 months after participating in Keep the Beat
Blood tests to identify EPCs and their function measure the level of nitric oxide a gas produced by healthy blood vessels and measure C-reactive protein an inflammatory marker that may be a risk factor for cardiovascular disease
Brachial artery reactivity study to measure how well the arteries widen An ultrasound device is placed over the subjects artery just above the elbow The device measures the size of the artery and the flow of blood through it before and after a pressure cuff is inflated around the forearm
Treadmill exercise testing to evaluate physical fitness Subjects exercise on a treadmill for as long as they can An exercise specialist is present throughout the test Heart rhythm and oxygen saturation are monitored continuously and blood pressure is measured every 3 minutes
Detailed Description:
Evidence suggests that Americans are becoming increasingly sedentary at work and at home due to technological advances Physical inactivity coupled with excess caloric intake especially of calorie-rich fast foods are responsible for the epidemic of obesity in this country Physical inactivity in obese and non-obese individuals increases the risk of cardiovascular disease and all-cause mortality Premature cardiovascular disease leads to lost productivity in the work place impaired quality of life and escalating health care costs In response to these concerns the American Heart Association advocates 30 minutes of aerobic exercise most days however busy schedules coupled with a lack of convenient access to exercise equipment or motivation to use it limit adoption of regular exercise by many One year ago the National Heart Lung and Blood Institute NHLBI initiated the Keep the Beat program which encourages Institute employees to engage in fifteen minutes of exercise during the work day and provides exercise equipment at specific work sites to accomplish this goal Yet fewer than 10 of NHLBI employees regularly participate in Keep the Beat and many who initially enrolled have failed to continue participation The purpose of our prospective cohort study is to determine whether participation in the Keep the Beat program can improve an important measure of cardiovascular risk-arterial endothelial function-by stimulating bone marrow-derived endothelial progenitor cells to repair endothelium We propose to characterize important components of vascular health by measuring endothelial nitric oxide bioactivity as determined by brachial artery reactivity to shear stress and nitric oxide metabolites in blood and vascular repair potential as determined by endothelial progenitor cell number and function at baseline and at 3 months in National Institutes of Health employees who agree to participate in Keep the Beat Secondary analyses will include other biomarkers of risk such as C-reactive protein blood pressure body mass index lipid profile fasting glucoseinsulin and homeostasis model assessment index to be measured in our study and subgroup analyses of participants at particularly high cardiovascular risk greater than 20 over 10 years minorities and women Demonstration of improved vascular function with implications of reduced cardiovascular risk may serve as an incentive for greater employee participation in established employer-initiated programs and for adoption of similar programs by other employers If objective benefit cannot be demonstrated in vascular function and other biomarkers of risk modification of the program may be required to reduce cardiovascular risk
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 |
|---|---|---|---|
| 06-H-0018 | None | None | None |