Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005447
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2000-05-25
Brief Title:
Physical Activity and Cardiovascular Disease Prevention
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:
2002-04
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 provide new scientific information regarding the role of physical activity in primary and secondary disease prevention particularly coronary heart disease CHD
Detailed Description:
DESIGN NARRATIVE
The long-term follow-up and data analysis of two epidemiologic studies a general population study and a clinical trial provided the basis for the study The first study assessed the long-term relationship between total physical activity both during work and leisure time and mortality in a random sample of 1656 Black and white men and women residents of the City of Buffalo New York The study focused on participants 30 years of age at baseline of the Buffalo Health Study an epidemiological investigation conducted in Buffalo in 1960 As part of the investigation detailed information was gathered from participants with regard to a number of demographic and socioeconomic characteristics age body mass index education marital status etc and the participants usual daily activities both during a weekday and weekend at work and outside work This information was used to compute a total physical activity index The study related the participants physical activity characteristics to their all-cause and CHD mortality experience throughout the follow-up period and tested whether or not the relationship between physical activity and mortality was similar across gender and race The detailed baseline demographic and socioeconomic data allowed analysis of the independence of any observed association between physical activity and mortality
The second study extended to 17 years the follow-up of the National Exercise and Heart Disease Project NEHDP a multi-center randomized clinical trial designed to study the effects of a regular medically prescribed and supervised exercise program on the rehabilitation of male survivors ages 30-64 at baseline of a myocardial infarction MI Three year findings from the trial reported non-significant differences between the treatment and control groups for all-cause mortality and recurrent MI in favor of the exercise group Other outcomes favoring the treatment group were reported after one year and included increased physical working capacity and decreased body fat diastolic blood pressure and triglycerides The study determined vital status for all original study participants and cause of death in the deceased The longer follow-up permitted analysis of whether the long-term survival of the treatment group differed from that of the controls In addition the investigators were able to assess if the risk factor changes observed in the first year of the trial were present after three years whether these changes were related to long-term survival whether differences in mortality observed in sub-groups ie smokers after three years remained after 17 years and whether baseline patient characteristics ie anxiety and depression predicted mortality
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
The long-term follow-up and data analysis of two epidemiologic studies a general population study and a clinical trial provided the basis for the study The first study assessed the long-term relationship between total physical activity both during work and leisure time and mortality in a random sample of 1656 Black and white men and women residents of the City of Buffalo New York The study focused on participants 30 years of age at baseline of the Buffalo Health Study an epidemiological investigation conducted in Buffalo in 1960 As part of the investigation detailed information was gathered from participants with regard to a number of demographic and socioeconomic characteristics age body mass index education marital status etc and the participants usual daily activities both during a weekday and weekend at work and outside work This information was used to compute a total physical activity index The study related the participants physical activity characteristics to their all-cause and CHD mortality experience throughout the follow-up period and tested whether or not the relationship between physical activity and mortality was similar across gender and race The detailed baseline demographic and socioeconomic data allowed analysis of the independence of any observed association between physical activity and mortality
The second study extended to 17 years the follow-up of the National Exercise and Heart Disease Project NEHDP a multi-center randomized clinical trial designed to study the effects of a regular medically prescribed and supervised exercise program on the rehabilitation of male survivors ages 30-64 at baseline of a myocardial infarction MI Three year findings from the trial reported non-significant differences between the treatment and control groups for all-cause mortality and recurrent MI in favor of the exercise group Other outcomes favoring the treatment group were reported after one year and included increased physical working capacity and decreased body fat diastolic blood pressure and triglycerides The study determined vital status for all original study participants and cause of death in the deceased The longer follow-up permitted analysis of whether the long-term survival of the treatment group differed from that of the controls In addition the investigators were able to assess if the risk factor changes observed in the first year of the trial were present after three years whether these changes were related to long-term survival whether differences in mortality observed in sub-groups ie smokers after three years remained after 17 years and whether baseline patient characteristics ie anxiety and depression predicted mortality
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R29HL054874 | NIH | None | httpsreporternihgovquickSearchR29HL054874 |