Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005169
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-05-25
Brief Title:
Lifestyle and Chronic Disease in College Alumni Harvard Alumni Health Study
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:
2002-10
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 monitor the relationship of lifestyle variables particularly exercise to cardiovascular mortality all-cause mortality projected longevity and aging and cardiovascular morbidity in a large cohort of college graduates To assess changing patterns of exercise cigarette smoking body weight and blood pressure between the 1960s and 1990s for relationship to cardiovascular morbidity and mortality
Detailed Description:
BACKGROUND
Hypertension and atherosclerotic cardiovascular disease have been ascribed to a variety of host-environmental characteristics -- cigarette smoking modern-day dietary practices abnormal blood lipid and blood glucose patterns obesity psychosocial factors genetics etc -- together with the decline in vigorous job activity because of mechanization and related developments in industry and transportation To the extent that job assignments limit exercise opportunities leisure-time physical activity may be of increasing importance in the control and reduction of coronary heart disease There is need to determine what levels frequencies and intensities of exercise exist in modern American lifestyles--particularly the trends of exercise enthusiasm and how these have changed during the periods of increasing and decreasing cardiovascular incidence from 1912-1967 and 1968 to date respectively There is need to know what physical demands on the human body are essential to maintain cardiac and vascular well-being in successive age groups including old age and what conversion from a sedentary to an active lifestyle can mean to the betterment or detriment of mans health The present study began as an intramural project of the National Heart Institute in 1961 and has continued to date becoming an extramural project in 1968 Approval was received from the NIH and the universities concerned to use the baseline data collected from college physical examinations social and athletic records of male students examined at Harvard University between 1916-1950 and at the University of Pennsylvania between 1931-1940
DESIGN NARRATIVE
This longitudinal study began in 1984 and built on college data from entrance physical examinations social and athletic records for 1916-1950 self-assessed mail questionnaire responses on six occasions from 1962-1980 and death certificates from 1916 to date A seventh lifestyle and health questionnaire was sent to living alumni in 1988 Exercise findings gathered from this and former questionnaires were converted into a physical activity index on the basis of estimated energy output ratings expressed in kilocalorie per unit of time and kilocalorie per kilogram per unit of time The 1988 questionnaire preserved comparability with earlier observations but allowed assessment of endurance body weight standard caloric values of specific physical activities and intensity and frequency of effort It was felt that such distinctions would aid an attempt to devise exercise prescriptions for men of differing ages and conditions of health To obtain current and historical medical data on alumni permission was requested of the study subjects to contact personal physicians Results of physical examinations completed by staff in 1962-1965 were provided to personal physicians of study subjects Similar results were provided to personal physicians of alumni undergoing treadmill and clinical testing in 1988
The study was renewed in 1996 in order to refine and extend observations on continuity and change in physical activity for relation to cardiovascular disease CVD morbidity and mortality to functional capacity and quality of life and to longevity and to direct special emphasis to the type intensity duration and timing of exercise that distinguish the effects of light moderate and vigorous activities on health In accomplishing these aims confounding interaction and trends of relations with personal characteristics and other health habits are taken into account Resources for study include 1 college student data of 1916-1950 collected from health social and athletic records 2 contemporary alumniae data collected on eight occasions 1962-1993 by mail questionnaires pertaining to physician-diagnosed disease physical exercise cigarette smoking body size and shape diet alcohol consumption other life way elements and family disease patterns and 3 annual cause-specific mortality certification 1916-1998 Anticipated deaths 1989-1998 from CHD will approximate 5500 from stroke 1000 and from all causes 14500 Non-fatal CHD and stroke events will increase these already large numbers substantially Using both prior and redefined definitions of physical activity the investigators will direct attention to continued and altered exercise patterns both increases and decreases in energy expenditure between the 1960s and 70s between the 70s and 80s and between the 80s and 90s for relation through 1998 to incidence of non-fatal and fatal CVD and to quality-adjusted years of life remaining Statistical power to detect relations between exercise and CVD will be considerable for alumni although weak for alumnae Special efforts are made to collect data from women in the Pennsylvania cohort The study ends in June 2000
Hypertension and atherosclerotic cardiovascular disease have been ascribed to a variety of host-environmental characteristics -- cigarette smoking modern-day dietary practices abnormal blood lipid and blood glucose patterns obesity psychosocial factors genetics etc -- together with the decline in vigorous job activity because of mechanization and related developments in industry and transportation To the extent that job assignments limit exercise opportunities leisure-time physical activity may be of increasing importance in the control and reduction of coronary heart disease There is need to determine what levels frequencies and intensities of exercise exist in modern American lifestyles--particularly the trends of exercise enthusiasm and how these have changed during the periods of increasing and decreasing cardiovascular incidence from 1912-1967 and 1968 to date respectively There is need to know what physical demands on the human body are essential to maintain cardiac and vascular well-being in successive age groups including old age and what conversion from a sedentary to an active lifestyle can mean to the betterment or detriment of mans health The present study began as an intramural project of the National Heart Institute in 1961 and has continued to date becoming an extramural project in 1968 Approval was received from the NIH and the universities concerned to use the baseline data collected from college physical examinations social and athletic records of male students examined at Harvard University between 1916-1950 and at the University of Pennsylvania between 1931-1940
DESIGN NARRATIVE
This longitudinal study began in 1984 and built on college data from entrance physical examinations social and athletic records for 1916-1950 self-assessed mail questionnaire responses on six occasions from 1962-1980 and death certificates from 1916 to date A seventh lifestyle and health questionnaire was sent to living alumni in 1988 Exercise findings gathered from this and former questionnaires were converted into a physical activity index on the basis of estimated energy output ratings expressed in kilocalorie per unit of time and kilocalorie per kilogram per unit of time The 1988 questionnaire preserved comparability with earlier observations but allowed assessment of endurance body weight standard caloric values of specific physical activities and intensity and frequency of effort It was felt that such distinctions would aid an attempt to devise exercise prescriptions for men of differing ages and conditions of health To obtain current and historical medical data on alumni permission was requested of the study subjects to contact personal physicians Results of physical examinations completed by staff in 1962-1965 were provided to personal physicians of study subjects Similar results were provided to personal physicians of alumni undergoing treadmill and clinical testing in 1988
The study was renewed in 1996 in order to refine and extend observations on continuity and change in physical activity for relation to cardiovascular disease CVD morbidity and mortality to functional capacity and quality of life and to longevity and to direct special emphasis to the type intensity duration and timing of exercise that distinguish the effects of light moderate and vigorous activities on health In accomplishing these aims confounding interaction and trends of relations with personal characteristics and other health habits are taken into account Resources for study include 1 college student data of 1916-1950 collected from health social and athletic records 2 contemporary alumniae data collected on eight occasions 1962-1993 by mail questionnaires pertaining to physician-diagnosed disease physical exercise cigarette smoking body size and shape diet alcohol consumption other life way elements and family disease patterns and 3 annual cause-specific mortality certification 1916-1998 Anticipated deaths 1989-1998 from CHD will approximate 5500 from stroke 1000 and from all causes 14500 Non-fatal CHD and stroke events will increase these already large numbers substantially Using both prior and redefined definitions of physical activity the investigators will direct attention to continued and altered exercise patterns both increases and decreases in energy expenditure between the 1960s and 70s between the 70s and 80s and between the 80s and 90s for relation through 1998 to incidence of non-fatal and fatal CVD and to quality-adjusted years of life remaining Statistical power to detect relations between exercise and CVD will be considerable for alumni although weak for alumnae Special efforts are made to collect data from women in the Pennsylvania cohort The study ends in June 2000
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?: