RecruitingNot Applicable

Examining the Impact of Exercise Training on Vascular Dysfunction in Individuals With Mental Health Disorders - Study 1

United States720 participantsStarted 2021-08-23

Plain-language summary

The purpose of this research study is to examine the role oxidants, substances produced in the blood that can damage blood vessel function, may play in blood vessel function in healthy individuals as well as individuals with mental health disorders (posttraumatic stress disorder (PTSD) and/or generalized anxiety disorder (GAD)).

Who can participate

Age range

18 Years – 35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * apparently healthy and free of overt cardiovascular, pulmonary, or metabolic disease * for PTSD group, a score of ≥ 33 on PCL-5 checklist * for GAD group, a score of ≥ 10 on the GAD-7 self-report scale and \< 33 on the PCL-5 checklist * for Healthy Control group, a score of ≤ 10 on the GAD-7 self-report scale and \< 33 on the PCL-5 checklist Exclusion Criteria: * taking medications that could influence cardiovascular function * current smokers who have recently quit smoking * illicit drug use or excessive alcohol consumption * pregnant women * significant calorie restriction or vitamin/mineral deficiencies * limited English proficiency

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Arm Vascular Function at Rest (Flow Mediated Dilation Test)

Timeframe: Baseline to the end of the final visit, about 2 weeks

Leg Vascular Function (Passive Leg Movement Test)

Timeframe: Baseline to the end of the final visit, about 2 weeks

Arm Vascular Function in Response to Exercise (Handgrip Exercise Test)

Timeframe: Baseline to the end of the final visit, about 2 weeks

Trial details

NCT IDNCT04916327

SponsorVirginia Commonwealth University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05

Contact for this trial

Ryan Garten, PhD

(804) 828-1948 rsgarten@vcu.edu

View on ClinicalTrials.gov More Peripheral Vascular Diseases trials

Plain-language summary

Who can participate

Age range

18 Years – 35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Arm Vascular Function at Rest (Flow Mediated Dilation Test)

Timeframe: Baseline to the end of the final visit, about 2 weeks

Leg Vascular Function (Passive Leg Movement Test)

Timeframe: Baseline to the end of the final visit, about 2 weeks

Arm Vascular Function in Response to Exercise (Handgrip Exercise Test)

Timeframe: Baseline to the end of the final visit, about 2 weeks