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

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

  • 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

  • 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

  • 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

Treatment groups

360 Participants
are divided into 3 treatment groups
Group A: Moderate Intensity, Normal Volume Exercise TrainingExperimental treatment 1 intervention
Group B: High Intensity, Normal Volume Exercise TrainingExperimental treatment 1 intervention
Group C: Moderate Intensity, High Volume Exercise TrainingExperimental 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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