Recruiting

Impact of Exercise Training on Vascular Dysfunction in Individuals with Mental Health Disorders

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Study Aim

This study aims to investigate how exercise training affects vascular function in individuals with mental health disorders, focusing on changes in arm and leg blood flow at rest and in response to exercise.

What is being tested

Antioxidant

+ Placebo

Dietary Supplement
Who is being recruted

Trauma and Stressor Related Disorders+4

+ Mental Disorders

+ Cardiovascular Diseases

From 18 to 35 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Interventional
Study Start: August 2021
See protocol details

Summary

Principal SponsorVirginia Commonwealth University
Study ContactRyan Garten, PhD
Last updated: March 13, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 23, 2021

Actual date on which the first participant was enrolled.

This study focuses on understanding how exercise training impacts vascular dysfunction in individuals with mental health disorders. It's a basic science study, which means it's designed to explore how certain things work in the body. The study is specifically interested in people with mental health disorders, as they may have unique vascular responses. The goal is to learn more about blood vessel health in this group, which could potentially improve care and treatment options. The study consists of three sessions, each held on a separate day, and can be completed in as little as two weeks. The first session is an introduction to the study equipment and procedures, and involves measuring body metrics like height, weight, and body fat, as well as determining forearm and calf strength. The next two sessions involve multiple tests to evaluate blood vessel health. In one session, participants will receive antioxidant pills, and in the other, they will receive placebo pills. This is to understand the role of oxidants in blood vessel health. The study measures changes in blood flow and artery dilation in response to rest and exercise, as well as during a passive leg movement test.

Official TitleExamining the Impact of Exercise Training on Vascular Dysfunction in Individuals With Mental Health Disorders - Study 1
NCT04916327
Principal SponsorVirginia Commonwealth University
Study ContactRyan Garten, PhD
Last updated: March 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

720 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 35 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Trauma and Stressor Related DisordersMental DisordersCardiovascular DiseasesStress Disorders, Post-TraumaticVascular DiseasesPeripheral Vascular DiseasesStress Disorders, Traumatic

Criteria

4 inclusion criteria required to participate
for Healthy Control group, a score of <= 10 on the GAD-7 self-report scale and < 33 on the PCL-5 checklist

for GAD group, a score of >= 10 on the GAD-7 self-report scale and < 33 on the PCL-5 checklist

apparently healthy and free of overt cardiovascular, pulmonary, or metabolic disease

for PTSD group, a score of >= 33 on PCL-5 checklist

6 exclusion criteria prevent from participating
taking medications that could influence cardiovascular function

current smokers who have recently quit smoking

illicit drug use or excessive alcohol consumption

pregnant women

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Subjects will ingest an antioxidant cocktail prior to their second visit and a placebo prior to third second visit

Group II

Experimental
Subjects will ingest a placebo prior to their second visit and an antioxidant cocktail prior to their third visit.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Virginia Commonwealth University

Richmond, United StatesOpen Virginia Commonwealth University in Google Maps
Recruiting
One Study Center