Cardiovascular DiseasesNCT00005169
Lifestyle and Chronic Disease in College Alumni (Harvard Alumni Health Study)
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Coronary Disease
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1984to Jun 2000
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
No eligibility criteria
About this study
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.
Read the 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 man's 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 alumni(ae) 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 5,500; from stroke, 1,000; and from all causes, 14,500. 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.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Coronary Disease, Hypertension, Cerebrovascular Accident
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Coronary Disease, Hypertension, Stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startSep 1984
- Study completionJun 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (46)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Ralph Paffenbarger, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005169
- Sponsor's protocol ID
- 1043
- Status last verified
- Oct 2002
- First submitted
- 25 May 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Paffenbarger RS Jr, Wing AL, Hyde RT, Jung DL. Physical activity and incidence of hypertension in college alumni. Am J Epidemiol. 1983 Mar;117(3):245-57. doi: 10.1093/oxfordjournals.aje.a113537.
PubMed 6829553Whittemore AS, Paffenbarger RS Jr, Anderson K, Halpern J. Early precursors of pancreatic cancer in college men. J Chronic Dis. 1983;36(3):251-6. doi: 10.1016/0021-9681(83)90059-0.
PubMed 6826689Paffenbarger RS Jr: Exercise in the Primary Prevention of Coronary Heart Disease. In: Heart Disease and Rehabilitation, M Pollock (Ed). New York: John Wiley & Sons, 2nd Ed., 1986.
Paffenbarger RS Jr, Hyde RT. Exercise in the prevention of coronary heart disease. Prev Med. 1984 Jan;13(1):3-22. doi: 10.1016/0091-7435(84)90037-9.
PubMed 6371776Paffenbarger RS Jr, Hyde RT, Wing AL, Steinmetz CH. A natural history of athleticism and cardiovascular health. JAMA. 1984 Jul 27;252(4):491-5.
PubMed 6737639Paffenbarger RS Jr, Hyde RT, Jung DL, Wing AL. Epidemiology of exercise and coronary heart disease. Clin Sports Med. 1984 Apr;3(2):297-318.
PubMed 6388854Whittemore AS, Paffenbarger RS Jr, Anderson K, Lee JE. Early precursors of urogenital cancers in former college men. J Urol. 1984 Dec;132(6):1256-61. doi: 10.1016/s0022-5347(17)50118-4.
PubMed 6502830Whittemore AS, Paffenbarger RS Jr, Anderson K, Lee JE. Early precursors of site-specific cancers in college men and women. J Natl Cancer Inst. 1985 Jan;74(1):43-51.
PubMed 3855486Paffenbarger RS Jr: Physical Activity as a Defense Against Coronary Heart Disease. In: Coronary Heart Disease, WE Connor and JD Bristow (Eds). Philadelphia: JB Lippincott Company, 1985
Powell KE, Paffenbarger RS Jr. Workshop on Epidemiologic and Public Health Aspects of Physical Activity and Exercise: a summary. Public Health Rep. 1985 Mar-Apr;100(2):118-26.
PubMed 3920710Paffenbarger RS Jr, Hyde RT: Exercise in the Primary Prevention of Ischemic Heart Disease. In: Current Therapy in Sports Medicine 1985-1986, RP Welsh and RJ Shephard (Eds.), St. Louis: CV Mosby Company, 1985
Spaulding RB (Ed), Paffenbarger RS Jr, Cooper KH, Fielding JE: Dialogue III - Health Promotion/Disease Prevention. Harvard Public Health Alumni Bulletin, p. 4-40, Spring 1985
Sasco AJ, Paffenbarger RS Jr. Measles infection and Parkinson's disease. Am J Epidemiol. 1985 Dec;122(6):1017-31. doi: 10.1093/oxfordjournals.aje.a114183.
PubMed 4061437Curfman GD, Thomas GS, Paffenbarger RS Jr: Physical Activity and Primary Prevention of Cardiovascular Disease. In: Cardiovascular Clinics (Symposium on Preventive Cardiology and Cardiac Rehabilitation), GD Curfman, A Leaf (Eds). Volume 3, Number 2:203-222. Philadelphia, WB Saunders Company, May 1985
Whittemore AS, Zheng S, Wu A, Wu ML, Fingar T, Jiao DA, Ling CD, Bao JL, Henderson BE, Paffenbarger RS Jr. Colorectal cancer in Chinese and Chinese-Americans. Natl Cancer Inst Monogr. 1985 Dec;69:43-6.
PubMed 3834343
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle and Chronic Disease in College Alumni (Harvard Alumni Health Study)
- ClinicalTrials.gov ID
- NCT00005169
- Acronym / sponsor ID
- 1043
- Conditions
- Cardiovascular Diseases, Heart Diseases, Coronary Disease, Hypertension, Cerebrovascular Accident
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 1984
- Study completion
- Jun 2000
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 man's 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 alumni(ae) 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 5,500; from stroke, 1,000; and from all causes, 14,500. 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 design
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- Background: PubMed 6829553Paffenbarger RS Jr, Wing AL, Hyde RT, Jung DL. Physical activity and incidence of hypertension in college alumni. Am J Epidemiol. 1983 Mar;117(3):245-57. doi: 10.1093/oxfordjournals.aje.a113537.
- Background: PubMed 6826689Whittemore AS, Paffenbarger RS Jr, Anderson K, Halpern J. Early precursors of pancreatic cancer in college men. J Chronic Dis. 1983;36(3):251-6. doi: 10.1016/0021-9681(83)90059-0.
- BackgroundPaffenbarger RS Jr: Exercise in the Primary Prevention of Coronary Heart Disease. In: Heart Disease and Rehabilitation, M Pollock (Ed). New York: John Wiley & Sons, 2nd Ed., 1986.
- Background: PubMed 6371776Paffenbarger RS Jr, Hyde RT. Exercise in the prevention of coronary heart disease. Prev Med. 1984 Jan;13(1):3-22. doi: 10.1016/0091-7435(84)90037-9.
- Background: PubMed 6737639Paffenbarger RS Jr, Hyde RT, Wing AL, Steinmetz CH. A natural history of athleticism and cardiovascular health. JAMA. 1984 Jul 27;252(4):491-5.
- Background: PubMed 6388854Paffenbarger RS Jr, Hyde RT, Jung DL, Wing AL. Epidemiology of exercise and coronary heart disease. Clin Sports Med. 1984 Apr;3(2):297-318.
- Background: PubMed 6502830Whittemore AS, Paffenbarger RS Jr, Anderson K, Lee JE. Early precursors of urogenital cancers in former college men. J Urol. 1984 Dec;132(6):1256-61. doi: 10.1016/s0022-5347(17)50118-4.
- Background: PubMed 3855486Whittemore AS, Paffenbarger RS Jr, Anderson K, Lee JE. Early precursors of site-specific cancers in college men and women. J Natl Cancer Inst. 1985 Jan;74(1):43-51.
- BackgroundPaffenbarger RS Jr: Physical Activity as a Defense Against Coronary Heart Disease. In: Coronary Heart Disease, WE Connor and JD Bristow (Eds). Philadelphia: JB Lippincott Company, 1985
- Background: PubMed 3920710Powell KE, Paffenbarger RS Jr. Workshop on Epidemiologic and Public Health Aspects of Physical Activity and Exercise: a summary. Public Health Rep. 1985 Mar-Apr;100(2):118-26.
- BackgroundPaffenbarger RS Jr, Hyde RT: Exercise in the Primary Prevention of Ischemic Heart Disease. In: Current Therapy in Sports Medicine 1985-1986, RP Welsh and RJ Shephard (Eds.), St. Louis: CV Mosby Company, 1985
- BackgroundSpaulding RB (Ed), Paffenbarger RS Jr, Cooper KH, Fielding JE: Dialogue III - Health Promotion/Disease Prevention. Harvard Public Health Alumni Bulletin, p. 4-40, Spring 1985
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralph Paffenbarger
Stanford University
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005169, which also lists 46 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.