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Tracking Information | |||||
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First Received Date † | July 29, 2005 | ||||
Last Updated Date | October 10, 2006 | ||||
Start Date † | July 2004 | ||||
Current Primary Outcome Measures † |
Diastolic function as assessed by mitral inflow filling pattern (E/A ratio) (measured at Month 6) | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00125476 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Effects of Exercise Training on Diastolic Heart Function in Postmenopausal Women | ||||
Official Title † | Training and Diastolic Function in Postmenopausal Women | ||||
Brief Summary | This study is a prospective follow-up study to the Dose-Response to Exercise in Women (DREW) study. In DREW, 450 overweight, sedentary postmenopausal women were randomly assigned to either a non-exercise control group or to 1 of 3 weekly physical activity groups. The DREW study is evaluating the dose-response of exercise training in regard to changes in multiple cardiac risk factors. This study will measure diastolic heart function in a subset of the DREW population in order to examine the relationship between dose response, changes in physical activity, and diastolic function. Diastolic heart function will be assessed using both traditional and novel echocardiographic measures. |
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Detailed Description | BACKGROUND: Congestive heart failure (CHF) has become the number one reason for hospitalization in the United States. Diastolic heart dysfunction is becoming increasingly recognized as a significant factor in the etiology of CHF. Of the total affected population, 70% of patients with diastolic heart failure are female, the majority of which are elderly. There is currently no effective pharmacological therapy for the treatment of diastolic heart dysfunction. Existing cross-sectional studies and limited training trials supporting the hypothesis that exercise may improve diastolic function have only studied men. There is a need for more properly controlled and adequately powered studies examining the effect of exercise training on diastolic function, particularly in populations at high risk for CHF, such as sedentary, postmenopausal women with elevated blood pressure. DESIGN NARRATIVE: A total of 215 sedentary, postmenopausal women at moderate risk for cardiovascular disease will be randomly assigned to receive either exercise training or no exercise for six months. This study will measure diastolic heart function using novel echocardiographic measurements, such as pulmonary vein flow pattern, tissue Doppler, and color M-mode mitral inflow propagation velocity. The study will also measure the left ventricular mass. |
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Study Phase | |||||
Study Type † | Interventional | ||||
Study Design † | Randomized, Open Label, Active Control, Parallel Assignment | ||||
Condition † |
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Intervention † | Behavioral: Exercise | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 215 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female | ||||
Ages | 45 Years to 75 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00125476 | ||||
Responsible Party | |||||
Secondary IDs †† | R21 HL077165 | ||||
Study Sponsor † | National Heart, Lung, and Blood Institute (NHLBI) | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) | ||||
Verification Date | October 2006 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |