Peripheral Vascular DiseasesNCT04922762
Examining the Impact of Exercise Training on Vascular Dysfunction in Individuals With Mental Health Disorders - Study 2
A study testing Moderate Intensity, Normal Volume Exercise Training, High Intensity, Normal Volume Exercise Training and Moderate Intensity, High Volume Exercise Training in people with Peripheral Vascular Diseases, run by Virginia Commonwealth University at 1 site in United States.
Trial 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)). Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Vascular Diseases
- What is being tested?
- Moderate Intensity, Normal Volume Exercise Training, High Intensity, Normal Volume Exercise Training and Moderate Intensity, High Volume Exercise Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2021to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
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)).
Read the 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
- Being tested
- Moderate Intensity, Normal Volume Exercise Training, High Intensity, Normal Volume Exercise Training, Moderate Intensity, High Volume Exercise Training
- Keywords
- cardiovascular disease, vascular function, PTSD, GAD, Oxidant
- Medical subject headings
- Peripheral Vascular Diseases, Cardiovascular Diseases, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate Intensity, Normal Volume Exercise TrainingBehavioural
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 TrainingBehavioural
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 TrainingBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Behavioral: Moderate Intensity, High Volume Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arm Vascular Function at Rest (Flow Mediated Dilation Test)
Change in Brachial Artery Dilation from Baseline Values
Measured: 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
Measured: 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
Measured: Baseline to the end of the final visit, about 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start6 Dec 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Vascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryan Garten, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922762
- Sponsor's protocol ID
- HM20020955-2
- Status last verified
- Nov 2025
- First submitted
- 24 May 2021
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Impact of Exercise Training on Vascular Dysfunction in Individuals With Mental Health Disorders - Study 2
- ClinicalTrials.gov ID
- NCT04922762
- Acronym / sponsor ID
- HM20020955-2
- Conditions
- Peripheral Vascular Diseases
- Keywords
- cardiovascular disease, vascular function, PTSD, GAD, Oxidant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Moderate Intensity, Normal Volume Exercise Training | Experimental | Behavioral: Moderate Intensity, Normal Volume Exercise TrainingParticipants will complete study 1 (HM20020955-1) and then 10 weeks of moderate intensity, normal volume exercise training |
| High Intensity, Normal Volume Exercise Training | Experimental | Behavioral: High Intensity, Normal Volume Exercise TrainingParticipants will complete study 1 (HM20020955-1) and then 10 weeks of high intensity, normal volume exercise training |
| Moderate Intensity, High Volume Exercise Training | Experimental | Behavioral: Moderate Intensity, High Volume Exercise TrainingParticipants will complete study 1 (HM20020955-1) and then 10 weeks of moderate intensity, high volume exercise training |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate Intensity, Normal Volume Exercise TrainingWeek 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 | Behavioural | Moderate Intensity, Normal Volume Exercise Training |
| High Intensity, Normal Volume Exercise TrainingWeek 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 | Behavioural | High Intensity, Normal Volume Exercise Training |
| Moderate Intensity, High Volume Exercise TrainingWeek 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 | Behavioural | Moderate Intensity, High Volume Exercise Training |
Primary outcome
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ryan Garten, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate Intensity, Normal Volume Exercise Training, High Intensity, Normal Volume Exercise Training and Moderate Intensity, High Volume Exercise Training in people with Peripheral Vascular Diseases, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ryan Garten, PhD ((804) 828-1948, rsgarten@vcu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.