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NCT04916340 | RECRUITING | Peripheral Vascular Diseases


Examining the Impact of Exercise Training on Vascular Dysfunction in Individuals With Mental Health Disorders - Study 3
Sponsor:

Virginia Commonwealth University

Brief Summary:

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)).

Condition or disease

Peripheral Vascular Diseases

Intervention/treatment

Muscular Strength Training Group

Muscular Fitness Training Group

Phase

NA

Detailed Description:

Study #3 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 two weight lifting programs that differ based on the amount of weight lifted (heavy vs moderate weight).

Study Type : INTERVENTIONAL
Estimated Enrollment : 240 participants
Masking : NONE
Primary Purpose : BASIC_SCIENCE
Official Title : Examining the Impact of Exercise Training on Vascular Dysfunction in Individuals With Mental Health Disorders - Study 3
Actual Study Start Date : 2022-01-24
Estimated Primary Completion Date : 2026-02-28
Estimated Study Completion Date : 2026-02-28

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 35 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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

Examining the Impact of Exercise Training on Vascular Dysfunction in Individuals With Mental Health Disorders - Study 3

Location Details

NCT04916340


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How to Participate

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Locations


RECRUITING

United States, Virginia

Virginia Commonwealth University

Richmond, Virginia, United States, 23298

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