RECRUITING

Heterogeneity of Vascular Adaptations to Exercise With Aging in Women and Men

Conditions

Aging Physical Activity Vascular Health Healthy Exercise training

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 differences between men and women. To achieve this goal, a mechanistic randomized controlled (RCT) will be conducted, in which adults are randomized to 12-weeks intervention of AE or no-exercise Control. Our overall hypothesis is that the exercise response variation in vascular benefits is related to age and sex differences in the biological changes underlying vascular aging and/or the molecular transducers (i.e., circulating molecules) that communicate and coordinate the effects of AE on the vasculature in the periphery and brain. Because this is a mechanistic trial, the overall goal is not a single health-related outcome. Rather, the goal is to advance our understanding of the molecular signals and pathways underlying the systemic and local effects of AE on vascular health that may explain the variability in AE responses with age and sex. This knowledge will allow for the development of personalized age- and sex-specific AE recommendations, and/or provide insights into molecular targets that can be manipulated to enhance and/or mimic exercise in non-responders or in persons unable to exercise.

Official Title

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

Quick Facts

Study Start:2025-05-13

Study Completion:2029-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06912984

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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;	* 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;

Inclusion Criteria

Exclusion 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;

* 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;

Contacts and Locations

Study Contact

Kerrie Moreau, PhD

CONTACT

(303)-724-1914

kerrie.moreau@cuanschutz.edu

Claire Cox

CONTACT

303-724-1396

claire.cox@cuanschutz.edu

Study Locations (Sites)

University of Colorado Anschutz Medical Center, Clinical Translational Research Center and Exercise Research Laboratory

Aurora, Colorado, 80045

United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-13

Study Completion Date2029-08-31

Study Record Updates

Study Start Date2025-05-13

Study Completion Date2029-08-31

Terms related to this study

Keywords Provided by Researchers

Healthy
Vascular Health
Exercise training

Additional Relevant MeSH Terms

Aging
Physical Activity
Vascular Health