Examining how exercise affects blood vessel health in people with mental health disorders
Examining the Impact of Exercise Training on Vascular Dysfunction in Individuals With Mental Health Disorders - Study 1
This study tests how exercise and antioxidant pills can improve blood vessel health in people with mental health disorders like PTSD and GAD, compared to healthy individuals.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 720 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | All |
| Sponsor | Virginia Commonwealth University Academic / other |
| Locations | 1 site (Richmond, Virginia) |
| Trial ID | NCT04916327 on ClinicalTrials.gov |
What this trial studies
This research investigates the impact of oxidants on blood vessel function in individuals with mental health disorders, specifically PTSD and GAD, as well as healthy individuals. The study consists of three sessions over two weeks, where participants will undergo various tests to assess their vascular health. In two of the sessions, participants will receive either antioxidant or placebo pills to evaluate the effects on their blood vessels. The goal is to better understand the relationship between mental health and cardiovascular function.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with PTSD or GAD, as well as healthy controls without cardiovascular issues.
Not a fit: Patients with significant cardiovascular, pulmonary, or metabolic diseases, or those on medications affecting cardiovascular function, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for individuals with mental health disorders by enhancing vascular health.
How similar studies have performed: While the specific approach of this study may be novel, previous studies have indicated potential benefits of exercise and antioxidant interventions on vascular health.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Richmond, Virginia
- Virginia Commonwealth University — Richmond, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Ryan Garten, PhD — Virginia Commonwealth University
- Study coordinator: Ryan Garten, PhD
- Email: rsgarten@vcu.edu
- Phone: (804) 828-1948
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.