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

NCT04916340 | Recruiting DMC

• 1 other identifier: HM20020955-3
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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)).

Conditions

Peripheral Vascular Diseases

Keywords

cardiovascular disease; vascular function; PTSD; GAD; Oxidant

Outcome Measures

Primary Outcomes (3)

• Arm Vascular Function at Rest (Flow Mediated Dilation Test)

  Change in Brachial Artery Dilation from Baseline Values

  Baseline to the end of the final visit, about 14 weeks

• Leg Vascular Function (Passive Leg Movement Test)

  Change in Leg Blood Flow Values from Baseline

  Baseline to the end of the final visit, about 14 weeks

• Arm Vascular Function in Response to Exercise (Handgrip Exercise Test)

  Change in Brachial Artery Dilation from Baseline Values

  Baseline to the end of the final visit, about 14 weeks

Study Arms (2)

Muscular Strength

EXPERIMENTAL

Participants will complete study 1 (HM20020955-1) and then 10 weeks of resistance training for muscular strength

Behavioral: Muscular Strength Training Group

Muscular fitness

EXPERIMENTAL

Participants will complete study 1 (HM20020955-1) and then 10 weeks of resistance training for muscular fitness

Behavioral: Muscular Fitness Training Group

Interventions

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 Strength

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

Muscular fitness

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

MeSH Terms

Conditions

Peripheral Vascular Diseases; Cardiovascular Diseases; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Vascular Diseases; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Ryan Garten, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ryan Garten, PhD

CONTACT

(804) 828-1948; rsgarten@vcu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: June 7, 2021
• Study Start: January 24, 2022
• Primary Completion (Estimated): December 28, 2026
• Study Completion (Estimated): December 28, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

US (1)