Examining the Effect of Mental Health Disorders on Vascular Function and Exercise Tolerance

Mental Health Disorders Clinical Trial

Official title:

Examining the Effect of Mental Health Disorders on Vascular Function and Exercise Tolerance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03216980
• Other study ID #: HM20009929
• Status: Completed
• Phase: N/A
• Start date: May 15, 2017
• Est. completion date: March 31, 2021

Study information

• Verified date: August 2021
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Specific Aim #1: Examining the impact of mental health disorders (PTSD and GAD) on peripheral vascular function and sympathetic nervous system activity in young individuals.

Specific Aim #2: Examining the impact of mental health disorders (PTSD and GAD) on peripheral hemodynamics and metabolic byproducts during small muscle mass exercise in young individuals.

Specific Aim #3: Examining the impact of mental health disorders (PTSD and GAD) on exercise tolerance, peripheral hemodynamics and metabolic byproducts during large muscle mass exercise in young individuals.

Description:

Mental health disorders are highly prevalent and underdiagnosed and can cause perturbations in cardiovascular and metabolic function leading to substantial individual burden (increased health care cost, loss of work productivity). Post-traumatic stress disorder (PTSD) and generalized anxiety disorder (GAD), two common mental health disorders, can cause increase cardiovascular disease risk due to chronic increases or fluctuations in heart rate, blood pressure, stress hormones, inflammation, and oxidative stress. Post-traumatic stress disorder (PTSD) is a disabling psychiatric condition characterized by a persistent maladaptive reaction resulting from exposure to severe psychological stress. It has been revealed that individuals with PTSD, in addition to adverse mental health symptoms, also possess higher prevalence rates for physical comorbidities such as hypertension, obesity, diabetes, and metabolic syndrome. Taken together, these PTSD-induced comorbidities result in a significant increase in the likelihood of developing cardiovascular disease (CVD) when compared to individuals without PTSD. Anxiety disorders, the most prevalent mental health issue in the United States, is associated an increased incidence of hypertension and heart disease. This increased cardiovascular disease (CVD) risk is thought to derive from an overactivation of the sympathetic nervous system that results in a predominately pro-oxidant, pro-inflammatory cardiovascular environment. Peripheral vascular dysfunction, or the inability of the blood vessels to adequately respond to specific stimuli, is a factor closely related to CVD. Therefore, this study will focus on a younger population with PTSD or GAD in an attempt to ascertain the presence of peripheral vascular dysfunction and the magnitude to which two potential primary contributors (autonomic dysfunction, oxidative stress) are involved in this dysfunction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Exclusion Criteria:

• taking medications that could influence cardiovascular function

• limited English proficiency

Related Conditions & MeSH terms

• Mental Disorders
• Mental Health Disorders

Intervention

Dietary Supplement:
• PTSD/GAD Antioxidant
Subjects will ingest an antioxidant cocktail containing 800 milligrams of alpha lipoic acid, 1 gram of vitamin C (ascorbic acid), and 400 milligrams of vitamin E (alpha tocopherol).
• PTSD/GAD Placebo
Subjects will ingest placebo (microcrystalline cellulose) pills.
• Healthy Control Antioxidant
Subjects will ingest an antioxidant cocktail containing 800 milligrams of alpha lipoic acid, 1 gram of vitamin C (ascorbic acid), and 400 milligrams of vitamin E (alpha tocopherol).
• Healthy Control Placebo
Subjects will ingest placebo (microcrystalline cellulose) pills.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arm Vascular Function at Rest (Flow Mediated Dilation Test) and in Response to Exercise (Handgrip Exercise Test)	Change in Brachial Artery Dilation from Baseline Values	Before and Immediately After Intervention
Primary	Leg Vascular Function (Passive Leg Movement Test)	Change in Leg Blood Flow Values from Baseline	Before and Immediately After Intervention