Recruiting

Exercise Training

Sponsor:

Virginia Commonwealth University

Code:

NCT04922762

Conditions

Peripheral Vascular Diseases

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

Interventions

Moderate Intensity, Normal Volume Exercise Training

High Intensity, Normal Volume Exercise Training

Moderate Intensity, High Volume Exercise Training

Study Details

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

Study ID

NCT04922762

Start date

Dec 6, 2021

Status verified date

Nov, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

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

Study Design

Enrollment

360 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Moderate Intensity, Normal Volume Exercise Training

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

experimental: High Intensity, Normal Volume Exercise Training

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

experimental: Moderate Intensity, High Volume Exercise Training

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

Interventions

Moderate Intensity, Normal Volume Exercise Training

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

High Intensity, Normal Volume Exercise Training

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

Moderate Intensity, High Volume Exercise Training

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

Primary outcome measure

  • Arm Vascular Function at Rest (Flow Mediated Dilation Test) [ Time Frame: Baseline to the end of the final visit, about 14 weeks ]
  • Leg Vascular Function (Passive Leg Movement Test) [ Time Frame: Baseline to the end of the final visit, about 14 weeks ]
  • Arm Vascular Function in Response to Exercise (Handgrip Exercise Test) [ Time Frame: Baseline to the end of the final visit, about 14 weeks ]

Central Contacts and Locations

Central contacts

Ryan Garten, PhD

(804) 828-1948rsgarten@vcu.edu

Locations

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

More Information

Sponsor

Virginia Commonwealth University

Last update posted

Nov 17, 2025

Last verified

Nov, 2025

Keywords

  • cardiovascular disease
  • vascular function
  • PTSD
  • GAD
  • Oxidant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Virginia Commonwealth University on 2025-11-17.