Sex Differences in Vascular Responses to Exercise

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

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

Conditions
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Aging

Intervention / Treatment
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* Behavioral: Control Period
* Behavioral: Exercise Period


Participation Criteria
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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 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)

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Older Men<br> | Behavioral: Control Period<br>* Subjects will complete an 8-week control period of normal lifestyle, followed by the 8-week exercise period.<br>Behavioral: Exercise Period<br>* 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.<br>|
| Active Comparator: Postmenopausal Women<br> | Behavioral: Control Period<br>* Subjects will complete an 8-week control period of normal lifestyle, followed by the 8-week exercise period.<br>Behavioral: Exercise Period<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High-Intensity Interval Training, Aerobic exercise, Acute exercise