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Clinical Trials/NCT04922762
NCT04922762
Recruiting
Not Applicable

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

Virginia Commonwealth University1 site in 1 country360 target enrollmentDecember 6, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peripheral Vascular Diseases
Sponsor
Virginia Commonwealth University
Enrollment
360
Locations
1
Primary Endpoint
Leg Vascular Function (Passive Leg Movement Test)
Status
Recruiting
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 6, 2021
End Date
December 1, 2026
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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 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

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

Study Sites (1)

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