Understanding how exercise affects blood vessels in aging adults

Exerkines and the Heterogeneity of Peripheral and Cerebral Vascular Adaptations to Exercise Training With Aging in Women and Men

This study is testing how a 12-week aerobic exercise program affects blood vessel health in middle-aged and older adults, looking at differences between men and women.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 242 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Colorado, Denver (Academic / other)
• Locations: 1 site (Aurora, Colorado)
• Trial ID: NCT06912984 on ClinicalTrials.gov

What this trial studies

This study aims to investigate the variability in the benefits of aerobic exercise on vascular health among middle-aged and older adults, focusing on differences between men and women. Participants will be randomly assigned to either a 12-week aerobic exercise program or a control group with no exercise. The study will assess various biological factors, including molecular signals and pathways, that may influence how exercise impacts vascular function. Data will be collected through biospecimens, fitness assessments, and health questionnaires to provide a comprehensive understanding of the effects of exercise on vascular health.

Who should consider this trial

Good fit: Ideal candidates include healthy men and women aged 18 and older who are sedentary or recreationally active and can participate in exercise.

Not a fit: Patients with orthopedic limitations, significant cardiovascular issues, or those on medications affecting cardiovascular function may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to tailored exercise recommendations that optimize vascular health in aging adults.

How similar studies have performed: Other studies have shown success in understanding exercise's impact on vascular health, but this study's specific focus on age and sex differences is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Ability to provide consent;
* Man or woman \>= 18 years;
* Willing to be randomized to an exercise or control intervention;
* No orthopedic limitations that would prevent the volunteer from performing treadmill or cycling exercise;
* No use of hormone therapy in postmenopausal women or in men (note, hormonal contraceptives in premenopausal women will be allowed);
* Healthy, as determined by medical history, physical examination, standard blood chemistries and ECG at rest and during a physician monitored graded exercise treadmill test;
* Sedentary or recreationally active (\<2 days/wk vigorous activity);
* No use of medications that might influence cardiovascular function (e.g., blood pressure and lipid lowering medications, metformin, insulin, sulfonylureas, etc.);
* No use of vitamins, supplements or anti-inflammatory medications, or willing to stop 1 month prior to enrollment and for the duration of the study;

Exclusion Criteria:

* Contraindications to aerobic exercise;
* Diabetic or fasted glucose \>126 mg/dL;
* Resting blood pressure \>= 140/90 mmHg;
* Current or past history of cancer other than skin cancer;
* Preexisting or active cardiac, renal or hepatic disease;
* History of stomach ulcer or bleeding or epilepsy or nervous system and/or seizure disorder;
* Active or chronic infection;
* An abnormal resting ECG, angina and/or ECG evidence of acute myocardial ischemia during the exercise test (development of ST-segment depression of more than 0.3 mV that is either horizontal, downsloping, or slowly upsloping- less than 1 mvolt/sec and lasts more than 0.08 sec; ST elevation; chest pain or discomfort), bundle branch block, AV block greater than first degree, arrhythmias;
* Thyroid dysfunction, defined as ultrasensitive TSH \<0.5 or \>5 mU/L. Participants with abnormal TSH values will be reconsidered for participation after follow-up with their PCP and initiation of thyroid replacement medications for at least 3 months;
* Smoking or tobacco use;
* Alcohol consumption \> 14 drinks/week;
* Body mass index \> 39kg/m2;

Where this trial is running

Aurora, Colorado

• University of Colorado Anschutz Medical Center, Clinical Translational Research Center and Exercise Research Laboratory — Aurora, Colorado, United States (Recruiting)

Study contacts

• Study coordinator: Kerrie Moreau, PhD

Conditions Aging; Physical Activity; Vascular Health; Healthy; Exercise training