- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT00005447
Physical Activity and Cardiovascular Disease Prevention
Studie Overzicht
Toestand
Gedetailleerde beschrijving
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 1,656 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 (i.e. smokers) after three years remained after 17 years, and whether baseline patient characteristics (i.e., 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.
Studietype
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Studie plan
Hoe is de studie opgezet?
Medewerkers en onderzoekers
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 4376
- R29HL054874 (Subsidie/contract van de Amerikaanse NIH)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .