Examining the Impact of Exercise Training on Vascular Dysfunction in Individuals With Mental Health Disorders - Study 2

Virginia Commonwealth University (VCU)

Status: Enrolling

Conditions: Peripheral Vascular Diseases

Treatments: Behavioral: Moderate Intensity, Normal Volume Exercise Training; Behavioral: Moderate Intensity, High Volume Exercise Training; Behavioral: High Intensity, Normal Volume Exercise Training

Study type: Interventional

Funder types: Other

Identifiers

NCT04922762

HM20020955-2

Details and patient eligibility

About

The purpose of this research study is to examine the effect of various forms of exercise training on blood vessel function in healthy individuals as well as individuals with mental health disorders (posttraumatic stress disorder (PTSD) and/or generalized anxiety disorder (GAD)).

Full description

Study #2 is made up of five sessions done on five separate days and the entire study can be completed in as little as 14 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. also include two additional testing days (Visits 5 and 6) that are identical to Visits #2 and #3, two visits to test endurance or strength prior to and after the exercise training (Visit 4 and 7), and ten weeks of exercise training (done 3-5 days per week). The exercise training will include one of three treadmill running programs that differ by exercise intensity and/or exercise frequency.

Enrollment: 360 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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360 participants in 3 patient groups

Moderate Intensity, Normal Volume Exercise Training

Experimental group

Description:

Participants will complete study 1 (HM20020955-1) and then 10 weeks of moderate intensity, normal volume exercise training

Treatment:

Behavioral: Moderate Intensity, Normal Volume Exercise Training

High Intensity, Normal Volume Exercise Training

Experimental group

Description:

Participants will complete study 1 (HM20020955-1) and then 10 weeks of high intensity, normal volume exercise training

Treatment:

Behavioral: High Intensity, Normal Volume Exercise Training

Moderate Intensity, High Volume Exercise Training

Experimental group

Description:

Participants will complete study 1 (HM20020955-1) and then 10 weeks of moderate intensity, high volume exercise training

Treatment:

Behavioral: Moderate Intensity, High Volume Exercise Training