Heterogeneity of Vascular Adaptations to Exercise With Aging in Women and Men
Launched by UNIVERSITY OF COLORADO, DENVER · Apr 2, 2025
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how exercise affects blood vessel health in middle-aged and older adults, particularly looking at differences between men and women. Researchers want to understand why some people experience more benefits from aerobic exercise, like walking or cycling, than others. To do this, they'll invite adults aged 18 and older who are not currently active to participate in a 12-week program where some will engage in aerobic exercise while others will not exercise at all. The goal is to find out how age and gender might influence the benefits of exercise on blood vessels, which could lead to personalized exercise recommendations in the future.
To participate, individuals must be generally healthy, able to consent, and willing to be assigned to either the exercise or control group. They should not have any serious medical conditions that would prevent them from exercising, and they must not be taking certain medications that could affect heart health. Participants can expect to undergo some health screenings before the study begins, and they will be monitored throughout the trial to help understand the effects of exercise on their vascular health. This research aims to provide insights that could help improve health outcomes for those who may not respond well to standard exercise programs.
Gender
ALL
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;
About University Of Colorado, Denver
The University of Colorado, Denver, is a leading academic institution dedicated to advancing medical research and improving healthcare outcomes. With a strong emphasis on innovation and collaboration, the university conducts a diverse range of clinical trials aimed at addressing critical health challenges. Its research initiatives are supported by a multidisciplinary team of experts, state-of-the-art facilities, and a commitment to ethical standards and patient safety. By fostering partnerships with local and global communities, the University of Colorado, Denver, strives to translate scientific discoveries into meaningful advancements in clinical practice and public health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Aurora, Colorado, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported