Sex Differences in Vascular Responses to Exercise

Not Applicable

Completed

• Conditions: Aging
• Interventions: Behavioral: Control Period; Behavioral: Exercise Period

• Registration Number: NCT04128215
• Lead Sponsor: University of Florida

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-10-14
• Study First Submitted QC: 2019-10-14
• Study First Posted: 2019-10-16
• Study Start: 2019-11-22
• Primary Completion: 2023-05-31
• Study Completion: 2023-05-31
• Results First Submitted: 2024-08-07
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-23
• Last Update Submitted: 2024-10-23
• Results First Posted: 2024-11-14
• Last Update Posted: 2024-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Postmenopausal Women	Control Period	-
Postmenopausal Women	Exercise Period	-
Older Men	Control Period	-
Older Men	Exercise Period	-

Primary Outcome Measures

Name	Time	Method
Change in FMD in Response to Chronic HIIT	From baseline to end of 8-week control period; From end of 8-week control period to end of 8-week exercise intervention	Flow mediated dilation (FMD) is an established non-invasive measure of endothelial function. Brachial artery FMD was determined via ultrasonography in response to reactive hyperemia following 5-min forearm ischemia. FMD was expressed as % change and was calculated as (max diameter-baseline-diameter)/baseline diameter)\*100. The change in FMD for the control period was calculated as the difference in FMD from baseline to the end of the 8-week control period. The change in FMD for the exercise intervention period was calculated as the difference in FMD from the end of the 8-week control period to the end of the 8-week intervention period.
Change in FMD in Response to Acute HIIT in the Untrained State	From pre-exercise to end of exercise; From pre-exercise to 1-hour post-exercise; From pre-exercise to 24-hours post-exercise	Flow mediated dilation (FMD) is an established non-invasive measure of endothelial function. Brachial artery FMD was determined via ultrasonography in response to reactive hyperemia following 5-min forearm ischemia. FMD was expressed as % change and was calculated as (max diameter-baseline-diameter)/baseline diameter)\*100. FMD was investigated at pre-exercise, at the end of a HIIT session, and 1-hour and 24-hours following a HIIT session in the untrained state (before beginning the 8-week exercise intervention consisting of HIIT). The change in FMD in response to acute HIIT was calculated 1) at the end of exercise (as the difference from pre-exercise to end of exercise); 2) 1-hour post-exercise (as the difference from pre-exercise to 1-hour post-exercise) and 3) 24-hours post-exercise (as the difference from pre-exercise to 24-hours post-exercise).
Change in FMD in Response to Acute HIIT in the Trained State	From pre-exercise to end of exercise; From pre-exercise to 1-hour post-exercise; From pre-exercise to 24-hours post-exercise	Flow mediated dilation (FMD) is an established non-invasive measure of endothelial function. Brachial artery FMD was determined via ultrasonography in response to reactive hyperemia following 5-min forearm ischemia. FMD was expressed as % change and was calculated as (max diameter-baseline-diameter)/baseline diameter)\*100. FMD was investigated at pre-exercise, at the end of a HIIT session, and 1-hour and 24-hours following a HIIT session in the trained state (at the end of the 8-week exercise intervention consisting of HIIT). The change in FMD in response to acute HIIT was calculated 1) at the end of exercise (as the difference from pre-exercise to end of exercise); 2) 1-hour post-exercise (as the difference from pre-exercise to 1-hour post-exercise) and 3) 24-hours post-exercise (as the difference from pre-exercise to 24-hours post-exercise).
Correlation Coefficient for the Relationship Between Acute and Chronic FMD Response to HIIT	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

Trial Locations

Locations (1)

Integrative Cardiovasculal Physiology Laboratory, University of Florida; 🇺🇸 Gainesville, Florida, United States