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

ConditionPeripheral Vascular Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-35
SponsorVirginia Commonwealth University

About this trial

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)).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

taking medications that could influence cardiovascular function

current smokers who have recently quit smoking

illicit drug use or excessive alcohol consumption

pregnant women

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 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

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: Muscular StrengthExperimental treatment 1 intervention
Group B: Muscular fitnessExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Arm Vascular Function at Rest (Flow Mediated Dilation Test)

Change in Brachial Artery Dilation from Baseline Values

Time frame
Baseline to the end of the final visit, about 14 weeks
2

Leg Vascular Function (Passive Leg Movement Test)

Change in Leg Blood Flow Values from Baseline

Time frame
Baseline to the end of the final visit, about 14 weeks
3

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

Change in Brachial Artery Dilation from Baseline Values

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Virginia Commonwealth University

Lead sponsor

Source ClinicalTrials.gov
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