Status:
COMPLETED
Effects of Exercise Training on Diastolic Heart Function in Postmenopausal Women
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Heart Failure, Congestive
Cardiovascular Diseases
Eligibility:
FEMALE
45-75 years
Phase:
NA
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-exerc...
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 ...
Eligibility Criteria
Inclusion
- Physically inactive for 6 months prior to study entry; defined as sedentary and having an energy expenditure of less than 35 kcal(kgˉ¹)(dayˉ¹)
- Postmenopausal and fits one of the following criteria: over 55 years old and no natural menses for at least 5 years; less than 55 years old and no natural menses for at least 2 years and a serum follicle stimulating hormone (FSH) level greater than 40 mIU/ml; hysterectomy with documentation of bilateral oophorectomy; less than 55 years old with a hysterectomy but no documentation of bilateral oophorectomy and with an FSH level greater than 40 mIU/ml and estradiol level less than 25 pg/ml
- If taking hormone replacement therapy, must have been on a stable dose for at least 6 months, and must maintain the same dosage of the same medication throughout the study
- Body mass index between 25 and 40 kg/m²
- Systolic blood pressure between 120 and 159 mm Hg and diastolic blood pressure no greater than 99 mm Hg
- Fasting plasma glucose level less than 126 mg/dl
- Physically capable of exercise
Exclusion
- Currently taking any antihypertensive medications
- Current or history of significant cardiovascular diseases or disorders, including arrythmias; myocarditis; cardiomyopathy; congestive heart failure; stroke or transient ischemic cerebral attacks; peripheral vascular disease with intermittent claudication; acute, chronic, or recurrent thrombophlebitis; and Stage II or III hypertension
- Current or history of total cholesterol level of at least 240 mg/dl with LDL-C level of at least 160 mg/dl or triglyceride levels of at least 300 mg/dl
- Current or history of hematologic disorders, including anemias, bleeding disorders, chronic thrombotic disorders, or hypercoagulable states
- Recent blood donation within the 6 weeks before study entry (participants also will be asked to refrain from blood donation during the study)
- Weight loss of 20 or more kilograms within the year prior to study entry
- Hospitalization for mental illness within 5 years of study entry or score of at least 10 on the Center for Epidemiological Studies Depression scale (CESD)
- Plans to be out of the city for more than 4 weeks over the next 6 months
- Other significant medical conditions, including the following: chronic or recurrent respiratory, gastrointestinal, neuromuscular, neurological, or psychiatric conditions; musculoskeletal problems interfering with exercise; autoimmune or collagen vascular diseases; immunodeficiency diseases or a positive HIV test; malignancies within 5 years of study entry, with the exception of skin cancer that is therapeutically controlled; endocrine and metabolic disorders; or any other medical condition or disease that is life-threatening or that may interfere with or be aggravated by exercise
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
215 Patients enrolled
Trial Details
Trial ID
NCT00125476
Start Date
July 1 2004
Last Update
October 11 2006
Active Locations (1)
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1
The Cooper Institute
Dallas, Texas, United States, 75230