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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Colorado, Denver

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

242 Participants
are divided into 2 treatment groups
Group A: Aerobic Exercise TrainingExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Endothelial function

Changes in brachial artery flow-mediated dilation calculated as %

Time frame
Baseline and after 12 weeks
2

Cerebrovascular function

Changes in cerebrovascular reactivity to a hypercapnic stimulus calculated as cm/s/mmHg

Time frame
Baseline and after 12 weeks

Secondary outcomes

1

Transcriptome in plasma

Changes in mRNA-based expression within blood plasma

Time frame
Baseline and after 12 weeks
2

Metabolome in plasma

Changes in metabolites within blood plasma

Time frame
Baseline and after 12 weeks
3

Proteome in plasma

Change in proteins within blood plasma

Time frame
Baseline and after 12 weeks
4

Endothelial microvesicles

Change in circulating EMVs

Time frame
Baseline and after 12 weeks

Other outcomes

1

Body composition

Change in total body fat measured as a %

Time frame
Baseline and after 12 weeks
2

Blood pressure

Change in seated blood pressure measured as mmHg

Time frame
Baseline and after 12 weeks
3

Endothelial cell oxidative stress

Change in the production of reactive oxygen species in cultured endothelial cells after incubation with participant serum

Time frame
Baseline and after 12 weeks
4

Endothelial cell nitric oxide production

Change in the production of nitric oxide in cultured endothelial cells after incubation with participant serum

Time frame
Baseline and after 12 weeks

Sponsors and contacts

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University of Colorado, Denver

Lead sponsor

National Institute on Aging (NIA)

Collaborator