Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000523
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-10-27
Brief Title:
Optimal Exercise Regimens for Persons at Increased Risk
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-01
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:
To assess exercise training adherence and compliance over two years in subjects who were at relatively high risk for coronary artery disease Also to test strategies for improving adherence and compliance and to assess the effect of exercise training
Detailed Description:
BACKGROUND
Regular physical exercise is associated with lower coronary heart disease mortality favorably affects coronary risk factors and increases cardiovascular functional capacity Fewer than one-third of Americans engage in regular physical exercise and only 20 percent of men and 10 percent of women over age 45 do so This is largely because effective strategies for increasing the exercise habit in a broadly-based segment of Americans have not been developed This study applied physiological and behavioral knowledge derived in numerous laboratories over the past 10-15 years to a clinical setting
DESIGN NARRATIVE
Following stratification by gender and cigarette smoking status subjects were randomized to one of four groups home exercise of moderate intensity which was individually monitored home exercise of high intensity which was individually monitored exercise of high intensity which was group supervised and a no program control group The intervention program was conducted for one year followed by a one-year maintenance program Main outcome measures included treadmill exercise test performance exercise participation rates and heart disease risk factors Variables measured over two years included plasma lipids lipoproteins apoproteins lipase activity glucose and insulin sex hormones cardiovascular reactivity to psychological stress cigarette smoking nutrient intake psychological status and cardiovascular functional capacity
Regular physical exercise is associated with lower coronary heart disease mortality favorably affects coronary risk factors and increases cardiovascular functional capacity Fewer than one-third of Americans engage in regular physical exercise and only 20 percent of men and 10 percent of women over age 45 do so This is largely because effective strategies for increasing the exercise habit in a broadly-based segment of Americans have not been developed This study applied physiological and behavioral knowledge derived in numerous laboratories over the past 10-15 years to a clinical setting
DESIGN NARRATIVE
Following stratification by gender and cigarette smoking status subjects were randomized to one of four groups home exercise of moderate intensity which was individually monitored home exercise of high intensity which was individually monitored exercise of high intensity which was group supervised and a no program control group The intervention program was conducted for one year followed by a one-year maintenance program Main outcome measures included treadmill exercise test performance exercise participation rates and heart disease risk factors Variables measured over two years included plasma lipids lipoproteins apoproteins lipase activity glucose and insulin sex hormones cardiovascular reactivity to psychological stress cigarette smoking nutrient intake psychological status and cardiovascular functional capacity
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: