Sex Differences in Vascular Responses to Exercise

University of Florida

Status: Completed

Conditions: Aging

Treatments: Behavioral: Control Period; Behavioral: Exercise Period

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04128215

IRB201902165- N

R21AG063143 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

A key early event in cardiovascular disease development is endothelial dysfunction, characterized by impaired flow-mediated dilation. Regular aerobic exercise ameliorates endothelial dysfunction in healthy older men, but the data in healthy postmenopausal women are inconsistent with many studies showing no effect. The primary objective of this study was to examine sex differences in acute and chronic endothelial responses to exercise training in older men vs. older postmenopausal women.

Enrollment: 20 patients

Sex: All

Ages: 60 to 79 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• adults able to give consent
• men and women
• women must be postmenopausal (either natural or surgical)
• 60 to 79 years of age

Exclusion criteria

• any relevant cardiovascular diseases (e.g., history of coronary artery bypass surgery or angioplasty, or heart failure, myocardial infarction, angina pectoris, peripheral arterial disease)
• myocardial ischemia during maximal graded exercise test
• major chronic clinical disease (e.g., diabetes, renal or hepatic disease or infection with hepatitis B, C, or HIV)
• seizures, or other relevant on-going or recurrent illness
• recent (within 3 months) or recurrent hospitalizations
• systolic blood pressure < 100 mmHg
• body mass index > 35 kg/m^2
• >5% weight change in past 3 months or unwilling to remain weight stable during study participation
• use of tobacco products including smoking traditional or e-cigarettes
• use of hormone replacement therapy in women or men (e.g., estrogen, progesterone or testosterone)
• regular aerobic exercise training (≥30 min/session and ≥ 3 days/week)

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Older Men

Active Comparator group

Treatment:

Behavioral: Exercise Period

Behavioral: Control Period

Older Postmenopausal Women

Active Comparator group

Treatment:

Behavioral: Exercise Period

Behavioral: Control Period