Status:
RECRUITING
Heterogeneity of Vascular Adaptations to Exercise With Aging in Women and Men
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Aging
Physical Activity
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of the proposed study is to understand the reasons for the variability in aerobic exercise (AE) training benefits on the vasculature in middle-age and older (MA/O) adults, including differenc...
Detailed Description
This is a single-blind (investigator and outcomes assessor), parallel-design clinical trial to determine whether heterogeneity in the biology of aging and molecular transducers with acute and chronic ...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
May 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2029
Estimated Enrollment :
242 Patients enrolled
Trial Details
Trial ID
NCT06912984
Start Date
May 28 2025
End Date
July 31 2029
Last Update
June 5 2025
Active Locations (1)
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1
University of Colorado Anschutz Medical Center, Clinical Translational Research Center and Exercise Research Laboratory
Aurora, Colorado, United States, 80045