Sex Differences in Vascular Responses to Exercise

NCT04128215 | Completed Results

• 2 other identifiers: IRB201902165- NR21AG063143
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging

Keywords

High-Intensity Interval Training; Aerobic exercise; Acute exercise

Outcome Measures

Primary Outcomes (4)

• Change in FMD in Response to Chronic HIIT

  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.

  From baseline to end of 8-week control period; From end of 8-week control period to end of 8-week exercise intervention

• Change in FMD in Response to Acute HIIT in the Untrained State

  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).

  From pre-exercise to end of exercise; From pre-exercise to 1-hour post-exercise; From pre-exercise to 24-hours post-exercise

• Change in FMD in Response to Acute HIIT in the Trained State

  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).

  From pre-exercise to end of exercise; From pre-exercise to 1-hour post-exercise; 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

Study Arms (2)

Older Men

ACTIVE COMPARATOR

Behavioral: Control Period; Behavioral: Exercise Period

Older Postmenopausal Women

ACTIVE COMPARATOR

Behavioral: Control Period; Behavioral: Exercise Period

Interventions

Control Period BEHAVIORAL

Participants completed an 8-week control period of normal lifestyle.

Older Men; Older Postmenopausal Women

Exercise Period BEHAVIORAL

Participants completed an 8-week exercise intervention period of remotely supervised home-based non-weight-bearing all-extremity high intensity interval training (NWA-HIIT). NWA-HIIT consisted 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 were included.

Older Men; Older Postmenopausal Women

Eligibility Criteria

• Age: 60 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Integrative Cardiovasculal Physiology Laboratory, University of Florida

Gainesville, Florida, 32611, United States

Location

Results Point of Contact

• Title: Dr. Demetra Christou
• Organization: University of Florida

ddchristou@ufl.edu

3522941715

Study Officials

• Demetra Christou, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: October 16, 2019
• Study Start: November 22, 2019
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: November 14, 2024
• Results First Posted: November 14, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)