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

NCT ID: NCT04922762

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-06
• Study Completion Date: 2026-12-31

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)).

Detailed Description

Study #2 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 three treadmill running programs that differ by exercise intensity and/or exercise frequency.

Conditions

Peripheral Vascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Moderate Intensity, Normal Volume Exercise Training

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

Group Type: EXPERIMENTAL

Moderate Intensity, Normal Volume Exercise Training

Intervention Type: 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

High Intensity, Normal Volume Exercise Training

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

Group Type: EXPERIMENTAL

High Intensity, Normal Volume Exercise Training

Intervention Type: 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

Moderate Intensity, High Volume Exercise Training

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

Group Type: EXPERIMENTAL

Moderate Intensity, High Volume Exercise Training

Intervention Type: 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

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

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ryan Garten, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ryan Garten, PhD

Role: CONTACT

rsgarten@vcu.edu

(804) 828-1948

Other Identifiers

HM20020955-2

Identifier Type: -

Identifier Source: org_study_id