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Sex Differences in Vascular Responses to Exercise

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04128215
Enrollment
20
Registered
2019-10-16
Start date
2019-11-22
Completion date
2023-05-31
Last updated
2024-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging

Keywords

High-Intensity Interval Training, Aerobic exercise, Acute exercise

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.

Interventions

BEHAVIORALControl Period

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

BEHAVIORALExercise Period

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.

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
University of Florida
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to 79 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in FMD in Response to Chronic HIITFrom baseline to end of 8-week control period; From end of 8-week control period to end of 8-week exercise interventionFlow 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 StateFrom pre-exercise to end of exercise; From pre-exercise to 1-hour post-exercise; From pre-exercise to 24-hours post-exerciseFlow 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 StateFrom pre-exercise to end of exercise; From pre-exercise to 1-hour post-exercise; From pre-exercise to 24-hours post-exerciseFlow 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 HIITAcute 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

Countries

United States

Participant flow

Participants by arm

ArmCount
Older Men
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.
9
Older Postmenopausal Women
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.
11
Total20

Baseline characteristics

CharacteristicOlder MenTotalOlder Postmenopausal Women
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
3 Participants11 Participants8 Participants
Age, Categorical
Between 18 and 65 years
6 Participants9 Participants3 Participants
Age, Continuous68 years
STANDARD_DEVIATION 6
68 years
STANDARD_DEVIATION 6
68 years
STANDARD_DEVIATION 5
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants2 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
8 Participants18 Participants10 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Flow Mediated Dilation3.41 % of flow mediated dilation
STANDARD_DEVIATION 0.89
3.39 % of flow mediated dilation
STANDARD_DEVIATION 1.38
3.38 % of flow mediated dilation
STANDARD_DEVIATION 1.73
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants1 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
8 Participants18 Participants10 Participants
Region of Enrollment
United States
9 Participants20 Participants11 Participants
Sex: Female, Male
Female
0 Participants11 Participants11 Participants
Sex: Female, Male
Male
9 Participants9 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 90 / 11
other
Total, other adverse events
3 / 98 / 11
serious
Total, serious adverse events
0 / 90 / 11

Outcome results

Primary

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).

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

ArmMeasureGroupValue (MEAN)Dispersion
Older Postmenopausal WomenChange in FMD in Response to Acute HIIT in the Trained StateEnd of exercise0.77 % flow mediated dilationStandard Deviation 2.24
Older Postmenopausal WomenChange in FMD in Response to Acute HIIT in the Trained State1-hour post-exercise-0.66 % flow mediated dilationStandard Deviation 2.59
Older Postmenopausal WomenChange in FMD in Response to Acute HIIT in the Trained State24-hours post-exercise-0.45 % flow mediated dilationStandard Deviation 1.71
Older MenChange in FMD in Response to Acute HIIT in the Trained StateEnd of exercise-0.07 % flow mediated dilationStandard Deviation 2.32
Older MenChange in FMD in Response to Acute HIIT in the Trained State1-hour post-exercise-0.63 % flow mediated dilationStandard Deviation 2.15
Older MenChange in FMD in Response to Acute HIIT in the Trained State24-hours post-exercise1.35 % flow mediated dilationStandard Deviation 1.79
Primary

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).

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

ArmMeasureGroupValue (MEAN)Dispersion
Older Postmenopausal WomenChange in FMD in Response to Acute HIIT in the Untrained StateEnd of exercise-0.46 % flow mediated dilationStandard Deviation 2.04
Older Postmenopausal WomenChange in FMD in Response to Acute HIIT in the Untrained State1-hour post-exercise-0.64 % flow mediated dilationStandard Deviation 1.97
Older Postmenopausal WomenChange in FMD in Response to Acute HIIT in the Untrained State24-hours post-exercise-0.53 % flow mediated dilationStandard Deviation 1.18
Older MenChange in FMD in Response to Acute HIIT in the Untrained StateEnd of exercise0.19 % flow mediated dilationStandard Deviation 1.85
Older MenChange in FMD in Response to Acute HIIT in the Untrained State1-hour post-exercise-1.28 % flow mediated dilationStandard Deviation 1.69
Older MenChange in FMD in Response to Acute HIIT in the Untrained State24-hours post-exercise0.12 % flow mediated dilationStandard Deviation 1.93
Primary

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.

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

ArmMeasureGroupValue (MEAN)Dispersion
Older Postmenopausal WomenChange in FMD in Response to Chronic HIITControl period0.11 % flow mediated dilationStandard Deviation 1.27
Older Postmenopausal WomenChange in FMD in Response to Chronic HIITExercise intervention0.81 % flow mediated dilationStandard Deviation 1.78
Older MenChange in FMD in Response to Chronic HIITControl period0.57 % flow mediated dilationStandard Deviation 2.07
Older MenChange in FMD in Response to Chronic HIITExercise intervention0.10 % flow mediated dilationStandard Deviation 2.36
Primary

Correlation Coefficient for the Relationship Between Acute and Chronic FMD Response to HIIT

Time frame: 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

ArmMeasureGroupValue (NUMBER)
Older Postmenopausal WomenCorrelation Coefficient for the Relationship Between Acute and Chronic FMD Response to HIIT24-hour post-exercise-0.17 Correlation coefficient
Older Postmenopausal WomenCorrelation Coefficient for the Relationship Between Acute and Chronic FMD Response to HIITEnd of exercise-0.32 Correlation coefficient
Older Postmenopausal WomenCorrelation Coefficient for the Relationship Between Acute and Chronic FMD Response to HIIT1-hour post-exercise0 Correlation coefficient
Older MenCorrelation Coefficient for the Relationship Between Acute and Chronic FMD Response to HIIT24-hour post-exercise0.07 Correlation coefficient
Older MenCorrelation Coefficient for the Relationship Between Acute and Chronic FMD Response to HIITEnd of exercise-0.26 Correlation coefficient
Older MenCorrelation Coefficient for the Relationship Between Acute and Chronic FMD Response to HIIT1-hour post-exercise-0.20 Correlation coefficient

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026