Recruiting

Aerobic Exercise

Sponsor:

University of Colorado, Denver

Code:

NCT06912984

Conditions

Aging

Physical Activity

Vascular Health

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Aerobic Exercise Training

Study Details

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 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.

Conditions

Aging

Physical Activity

Vascular Health

Study ID

NCT06912984

Start date

May 28, 2025

Status verified date

Jun, 2025

Completion date

Jul 31, 2029

Anticipated

Primary completion date

Jul 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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;

Study Design

Enrollment

242 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Aerobic Exercise Training

Participants randomized to this arm will engage in moderate-intensity aerobic exercise (AE) training program consisting of treadmill walking/running and upright cycling. The training program involves 3 training sessions per week for 12 weeks. Each session will be ≈ 60 minutes in duration.

During the 12-week intervention, participants will maintain their typical diet and daily physical activity, aside from the prescribed training program. Participants will periodically check in with the study team to assess any changes in weight and report any changes in their physical activity, diet, or medications.

no intervention: Control

Participants randomized to this arm will serve as the non-exercise control group. During the 12-week control period, participants will maintain their typical daily physical activity and diet. Participants will periodically check in with the study team to assess any changes in weight and report any changes in their physical activity, diet, or medications.

Interventions

Aerobic Exercise Training

The aerobic exercise training intervention will consist of moderate-intensity aerobic exercise training program consisting of treadmill walking/running and upright cycling. The training program involves 3 training sessions per week for 12 weeks. Each session will be ≈ 60 minutes in duration.

Primary outcome measure

  • Endothelial function [ Time Frame: Baseline and after 12 weeks ]
  • Cerebrovascular function [ Time Frame: Baseline and after 12 weeks ]

Central Contacts and Locations

Central contacts

Kerrie Moreau, PhD

(303)-724-1914kerrie.moreau@cuanschutz.edu

Claire Cox

303-724-1396claire.cox@cuanschutz.edu

Locations

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

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Kerrie Moreau, PhD

303-724-1914kerrie.moreau@cuanschutz.edu

Claire Cox, BA

303-724-1396claire.cox@cuanschutz.edu

Principal Investigator:

Kerrie Moreau, PhD

More Information

Sponsor

University of Colorado, Denver

Last update posted

Jun 5, 2025

Last verified

Jun, 2025

Keywords

  • Healthy
  • Vascular Health
  • Exercise training

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2025-06-05.