Examining the Impact of Exercise Training on Vascular Dysfunction in Individuals With Mental Health Disorders - Study 2
Primary Purpose
Peripheral Vascular Diseases
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Moderate Intensity, Normal Volume Exercise Training
High Intensity, Normal Volume Exercise Training
Moderate Intensity, High Volume Exercise Training
Sponsored by
About this trial
This is an interventional basic science trial for Peripheral Vascular Diseases focused on measuring cardiovascular disease, vascular function, PTSD, GAD, Oxidant
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
Sites / Locations
- Virginia Commonwealth UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Moderate Intensity, Normal Volume Exercise Training
High Intensity, Normal Volume Exercise Training
Moderate Intensity, High Volume Exercise Training
Arm Description
Participants will complete study 1 (HM20020955-1) and then 10 weeks of moderate intensity, normal volume exercise training
Participants will complete study 1 (HM20020955-1) and then 10 weeks of high intensity, normal volume exercise training
Participants will complete study 1 (HM20020955-1) and then 10 weeks of moderate intensity, high volume exercise training
Outcomes
Primary Outcome Measures
Arm Vascular Function at Rest (Flow Mediated Dilation Test)
Change in Brachial Artery Dilation from Baseline Values
Leg Vascular Function (Passive Leg Movement Test)
Change in Leg Blood Flow Values from Baseline
Arm Vascular Function in Response to Exercise (Handgrip Exercise Test)
Change in Brachial Artery Dilation from Baseline Values
Secondary Outcome Measures
Full Information
NCT ID
NCT04922762
First Posted
May 24, 2021
Last Updated
August 3, 2023
Sponsor
Virginia Commonwealth University
1. Study Identification
Unique Protocol Identification Number
NCT04922762
Brief Title
Examining the Impact of Exercise Training on Vascular Dysfunction in Individuals With Mental Health Disorders - Study 2
Official Title
Examining the Impact of Exercise Training on Vascular Dysfunction in Individuals With Mental Health Disorders - Study 2
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 6, 2021 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Vascular Diseases
Keywords
cardiovascular disease, vascular function, PTSD, GAD, Oxidant
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Moderate Intensity, Normal Volume Exercise Training
Arm Type
Experimental
Arm Description
Participants will complete study 1 (HM20020955-1) and then 10 weeks of moderate intensity, normal volume exercise training
Arm Title
High Intensity, Normal Volume Exercise Training
Arm Type
Experimental
Arm Description
Participants will complete study 1 (HM20020955-1) and then 10 weeks of high intensity, normal volume exercise training
Arm Title
Moderate Intensity, High Volume Exercise Training
Arm Type
Experimental
Arm Description
Participants will complete study 1 (HM20020955-1) and then 10 weeks of moderate intensity, high volume exercise training
Intervention Type
Behavioral
Intervention Name(s)
Moderate Intensity, Normal Volume Exercise Training
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
High Intensity, Normal Volume Exercise Training
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Moderate Intensity, High Volume Exercise Training
Intervention Description
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
Primary Outcome Measure Information:
Title
Arm Vascular Function at Rest (Flow Mediated Dilation Test)
Description
Change in Brachial Artery Dilation from Baseline Values
Time Frame
Baseline to the end of the final visit, about 14 weeks
Title
Leg Vascular Function (Passive Leg Movement Test)
Description
Change in Leg Blood Flow Values from Baseline
Time Frame
Baseline to the end of the final visit, about 14 weeks
Title
Arm Vascular Function in Response to Exercise (Handgrip Exercise Test)
Description
Change in Brachial Artery Dilation from Baseline Values
Time Frame
Baseline to the end of the final visit, about 14 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ryan Garten, PhD
Phone
(804) 828-1948
Email
rsgarten@vcu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Garten, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
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Examining the Impact of Exercise Training on Vascular Dysfunction in Individuals With Mental Health Disorders - Study 2
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