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

  • STATUS
    Recruiting
  • days left to enroll
    70
  • participants needed
    720
  • sponsor
    Virginia Commonwealth University
Updated on 2 September 2021
vitamin e
antioxidant

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)).

Description

Study #1 is made up of three sessions done on three separate days and the entire study can be completed in as little as two weeks. All testing sessions will take place at the Exercise Physiology Research Laboratory. Volunteers will be asked to participate in one initial testing session (Visit 1) lasting < 1 hour that will help make them more familiar with the study equipment and procedures, determine body measures (height, weight, body fat), determine the maximum strength of their forearm and calf, and require one blood draw. The following two testing sessions (Visits 2 and 3) with each session lasting between 2-3 hours that will involve multiple tests designed to determine the health of their blood vessels. For Visit #2 they will be randomly given either antioxidant pills or placebo pills to determine the effect of oxidants on blood vessel health. For Visit #3, they will be given whatever set of pills (antioxidant or placebo) that they did not receive during Visit #2.

Details
Condition Peripheral Vascular Disease, peripheral arterial disease, Peripheral vascular disease, Vascular Diseases, Peripheral Arterial Disease (PAD), Atherosclerosis, Circulation Disorders
Treatment Placebo, Antioxidant
Clinical Study IdentifierNCT04916327
SponsorVirginia Commonwealth University
Last Modified on2 September 2021

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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