Clinical trial NCT03216980: Examining the Effect of Mental Health Disorders on Vascular Function and Exercise Tolerance
Official title: Examining the Effect of Mental Health Disorders on Vascular Function and Exercise Tolerance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Disorders
Keywords: cardiovascular disease
vascular function
PTSD
GAD
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2017-07-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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.

Eligibility 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

Exclusion Criteria:

* taking medications that could influence cardiovascular function
* limited English proficiency

Primary outcomes:
measure: Arm Vascular Function at Rest (Flow Mediated Dilation Test) and in Response to Exercise (Handgrip Exercise Test)
timeFrame: Before and Immediately After Intervention
measure: Leg Vascular Function (Passive Leg Movement Test)
timeFrame: Before and Immediately After Intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Ryan Garten, PhD
role: PRINCIPAL_INVESTIGATOR
References: