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NCT Number: NCT04916340

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

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)).

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Key information

Conditions

Peripheral Vascular Diseases Cardiovascular Diseases Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Vascular Diseases

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location status: Recruiting

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Muscular Strength Training Group

Behavioral

Week 1 3 days/week Bench Press - 1 set at 80% of one repetition maximum

(1RM) Bent Over Row - 1 set at 80% 1RM Back Squat - 1 set at 80% 1RM Romanian Deadlift - 1 set at 80% 1RM

Week 2 3 days/week Bench Press - 2 sets at 80% 1RM Bent Over Row - 2 sets at 80% 1RM Back Squat - 2 sets at 80% 1RM Romanian Deadlift - 2 sets at 80% 1RM

Weeks 3-10 3 days/week Bench Press - 3 sets at 80% 1RM Bent Over Row - 3 sets at 80% 1RM Back Squat - 3 sets at 80% 1RM Romanian Deadlift - 3 sets at 80% 1RM

Muscular Fitness Training Group

Behavioral

Week 1 3 days/week Bench Press - 1 set at 65% 1RM Bent Over Row - 1 set at 65% 1RM Back Squat - 1 set at 65% 1RM Romanian Deadlift - 1 set at 65% 1RM

Week 2 3 days/week Bench Press - 2 sets at 65% 1RM Bent Over Row - 2 sets at 65% 1RM Back Squat - 2 sets at 65% 1RM Romanian Deadlift - 2 sets at 65% 1RM

Weeks 3-10 3 days/week Bench Press - 3 sets at 65% 1RM Bent Over Row - 3 sets at 65% 1RM Back Squat - 3 sets at 65% 1RM Romanian Deadlift - 3 sets at 65% 1RM

Primary outcomes

  1. Arm Vascular Function at Rest (Flow Mediated Dilation Test)

    Time frame: Baseline to the end of the final visit, about 14 weeks

    Change in Brachial Artery Dilation from Baseline Values

  2. Leg Vascular Function (Passive Leg Movement Test)

    Time frame: Baseline to the end of the final visit, about 14 weeks

    Change in Leg Blood Flow Values from Baseline

  3. Arm Vascular Function in Response to Exercise (Handgrip Exercise Test)

    Time frame: Baseline to the end of the final visit, about 14 weeks

    Change in Brachial Artery Dilation from Baseline Values

Study contacts

Contact information is provided by the study sponsor or research team.

Ryan Garten, PhD

CONTACT

[email protected]

(804) 828-1948

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jun 7, 2021
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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