Clinical trial NCT04128215: Sex Differences in Vascular Responses to Exercise
Official title: Sex Differences in Chronic and Acute Vascular Responses to Aerobic Exercise in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: High-Intensity Interval Training
Aerobic exercise
Acute exercise
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2019-10-16
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change in FMD in Response to Chronic HIIT
timeFrame: From baseline to end of 8-week control period; From end of 8-week control period to end of 8-week exercise intervention
measure: Change in FMD in Response to Acute HIIT in the Untrained State
timeFrame: From pre-exercise to end of exercise; From pre-exercise to 1-hour post-exercise; From pre-exercise to 24-hours post-exercise
measure: Change in FMD in Response to Acute HIIT in the Trained State
timeFrame: From pre-exercise to end of exercise; From pre-exercise to 1-hour post-exercise; From pre-exercise to 24-hours post-exercise
measure: Correlation Coefficient for the Relationship Between Acute and Chronic FMD Response to HIIT
timeFrame: Acute FMD response at 1) pre-exercise vs. end of exercise; 2) pre-exercise vs. 1-hour post-exercise; and 3) pre-exercise vs. 24-hours post-exercise. Chronic FMD response at baseline vs. end of 8-week. exercise intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Integrative Cardiovasculal Physiology Laboratory, University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Demetra Christou, PhD
role: PRINCIPAL_INVESTIGATOR
References: