Sex Differences in Vascular Responses to Exercise

Aging Clinical Trial

Official title:

Sex Differences in Chronic and Acute Vascular Responses to Aerobic Exercise in Older Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04128215
• Other study ID #: IRB201902165- N
• Secondary ID: R21AG063143
• Status: Recruiting
• Phase: N/A
• Start date: November 22, 2019
• Est. completion date: May 31, 2024

Study information

• Verified date: August 2023
• Source: University of Florida
• Contact: Demetra Christou, PhD
• Phone: 352-294-1746
• Email: ddchristou[@]ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 is to examine sex differences in acute and chronic endothelial responses to exercise training in older men vs. postmenopausal women.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 33
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 79 Years

Eligibility

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

• body mass index > 35 kg/m2

• >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)

Related Conditions & MeSH terms

• Aging

Intervention

Behavioral:
• Control Period
Subjects will complete an 8-week control period of normal lifestyle, followed by the 8-week exercise period.
• Exercise Period
Subjects will complete an 8-week non-weight-bearing all-extremity high intensity interval training (NWA-HIIT). NWA-HIIT will consist of 4x4-min bouts at 90% of maximal heart rate (HRmax) interspersed by 3x3-min bouts at 70% of HRmax. A 10-min warm-up and 5-minute cool-down at 70% of HRmax will be included.

Locations

Country	Name	City	State
United States	Integrative Cardiovasculal Physiology Laboratory, University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in brachial FMD	Flow mediated dilation (FMD) is an established non-invasive measure of endothelial function. Brachial artery FMD will be determined via ultrasonography in response to reactive hyperemia following 5-min forearm ischemia. FMD will be expressed as % change and will be calculated as (max diameter-baseline-diameter)/baseline diameter)*100.	Baseline; Following 8 weeks of normal lifestyle; Following 8 weeks of HIIT