Effects of Exercise Training on Diastolic Heart Function in Postmenopausal Women

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00125476
• Date of registration: 29/07/2005
• Primary sponsor: National Heart, Lung, and Blood Institute (NHLBI)
• Public title: Effects of Exercise Training on Diastolic Heart Function in Postmenopausal Women
• Scientific title: Training and Diastolic Function in Postmenopausal Women
• Date of first enrolment: July 2004
• Target sample size: 215
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00125476
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Countries of recruitment

United States

Contacts

• Name: Steven Blair
• Affiliation: The Cooper Institute

Key inclusion & exclusion criteria

Inclusion Criteria:

- Physically inactive for 6 months prior to study entry; defined as sedentary and
having an energy expenditure of less than 35 kcal(kg¯¹)(day¯¹)

- 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 Criteria:

- 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



Age minimum: 45 Years
Age maximum: 75 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Cardiovascular Diseases

Heart Failure, Congestive

Intervention(s)

Behavioral: Exercise

Primary Outcome(s)

Diastolic function as assessed by mitral inflow filling pattern (E/A ratio) (measured at Month 6)

Secondary Outcome(s)

Color M-mode mitral inflow propagation velocity

Left ventricular mass (measured at Month 6)

Pulmonary vein flow pattern

Tissue Doppler

Secondary ID(s)

235

R21 HL077165

Source(s) of Monetary Support

Please refer to primary and secondary sponsors