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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Peripheral Vascular Diseases

Intervention / Treatment
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* Behavioral: Moderate Intensity, Normal Volume Exercise Training
* Behavioral: High Intensity, Normal Volume Exercise Training
* Behavioral: Moderate Intensity, High Volume Exercise Training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moderate Intensity, Normal Volume Exercise Training<br>Participants will complete study 1 (HM20020955-1) and then 10 weeks of moderate intensity, normal volume exercise training | Behavioral: Moderate Intensity, Normal Volume Exercise Training<br>* 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<br>|
| Experimental: High Intensity, Normal Volume Exercise Training<br>Participants will complete study 1 (HM20020955-1) and then 10 weeks of high intensity, normal volume exercise training | Behavioral: High Intensity, Normal Volume Exercise Training<br>* 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<br>|
| Experimental: Moderate Intensity, High Volume Exercise Training<br>Participants will complete study 1 (HM20020955-1) and then 10 weeks of moderate intensity, high volume exercise training | Behavioral: Moderate Intensity, High Volume Exercise Training<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arm Vascular Function at Rest (Flow Mediated Dilation Test) | Change in Brachial Artery Dilation from Baseline Values | 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 | 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 | Baseline to the end of the final visit, about 14 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD, cardiovascular disease, vascular function, GAD, Oxidant