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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT06912984
Status
Recruiting
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Conditions

  • Aging
  • Physical Activity
  • Vascular Health

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Aerobic Exercise Training — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
May 28, 2025
Status verified
Jun 2025
Primary completion
Jul 31, 2029
Completion
Jul 31, 2029

Study Design

Enrollment
242 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado Anschutz Medical Center, Clinical Translational Research Center and Exercise Research LaboratoryAuroraColorado80045
Kerrie Moreau, PhD
[email protected]
303-724-1914
Claire Cox, BA
[email protected]
303-724-1396
Kerrie Moreau, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Colorado Anschutz Medical Center, Clinical Translational Research Center and Exercise Research Laboratory· Aurora, CO

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