Sex Differences in Vascular Responses to Exercise

NCT ID: NCT04128215

Last Updated: 2024-11-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-22

Study Completion Date

2023-05-31

Brief Summary

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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

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Conditions

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Aging

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Older Men

Group Type ACTIVE_COMPARATOR

Control Period

Intervention Type BEHAVIORAL

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

Exercise Period

Intervention Type 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 Postmenopausal Women

Group Type ACTIVE_COMPARATOR

Control Period

Intervention Type BEHAVIORAL

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

Exercise Period

Intervention Type 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.

Interventions

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Control Period

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

Intervention Type BEHAVIORAL

Exercise 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

60 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Demetra Christou, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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Integrative Cardiovasculal Physiology Laboratory, University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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R21AG063143

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB201902165- N

Identifier Type: -

Identifier Source: org_study_id

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