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

NCT04922762 | Recruiting DMC

• 1 other identifier: HM20020955-2
• Study Type: interventional
• Target: 360
• 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 (3)

Moderate Intensity, Normal Volume Exercise Training

EXPERIMENTAL

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

Behavioral: Moderate Intensity, Normal Volume Exercise Training

High Intensity, Normal Volume Exercise Training

EXPERIMENTAL

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

Behavioral: High Intensity, Normal Volume Exercise Training

Moderate Intensity, High Volume Exercise Training

EXPERIMENTAL

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

Behavioral: Moderate Intensity, High Volume Exercise Training

Interventions

Moderate Intensity, Normal Volume Exercise Training BEHAVIORAL

Week 1 3 days/week for 20 minutes/day Performed at 70% of heart rate maximum Week 2 3 days/week for 30 minutes/day Performed at 70% of heart rate maximum Weeks 3-10 3 days/week for 45 minutes/day Performed at 70% of heart rate maximum

Moderate Intensity, Normal Volume Exercise Training

High Intensity, Normal Volume Exercise Training BEHAVIORAL

Week 1 3 days/week for 31 minutes/day 10 minute warm up at 50% of heart rate maximum 2 x 4 minute intervals 4 minutes at 90-95% of heart rate maximum 3 minutes at 70% of heart rate maximum REPEAT 7 minute cool down at 50% of heart rate maximum Week 2 3 days/week for 38 minutes/day 10 minute warm up at 50% of heart rate maximum 3 x 4 minute intervals 4 minutes at 90-95% of heart rate maximum 3 minutes at 70% of heart rate maximum REPEAT 2 TIMES 7minute cool down at 50% of heart rate maximum Weeks 3-10 3 days/week for 45 minutes/day 10 minute warm up at 50% of heart rate maximum 4 x 4 minute intervals 4 minutes at 90-95% of heart rate maximum 3 minutes at 70% of heart rate maximum REPEAT 3 TIMES 7 minute cool down at 50% of heart rate maximum

High Intensity, Normal Volume Exercise Training

Moderate Intensity, High Volume Exercise Training BEHAVIORAL

Week 1 5 days/week for 20 minutes/day Performed at 70% of heart rate maximum Week 2 5 days/week for 30 minutes/day Performed at 70% of heart rate maximum Weeks 3-10 5 days/week for 45 minutes/day Performed at 70% of heart rate maximum

Moderate Intensity, High Volume Exercise Training

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 11, 2021
• Study Start: December 6, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

US (1)