- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04922762
Examining the Impact of Exercise Training on Vascular Dysfunction in Individuals With Mental Health Disorders - Study 2
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ryan Garten, PhD
- Phone Number: (804) 828-1948
- Email: rsgarten@vcu.edu
Study Locations
-
-
Virginia
-
Richmond, Virginia, United States, 23298
- Recruiting
- Virginia Commonwealth University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Moderate Intensity, Normal Volume Exercise Training
Participants will complete study 1 (HM20020955-1) and then 10 weeks of moderate intensity, normal volume exercise training
|
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 |
Experimental: High Intensity, Normal Volume Exercise Training
Participants will complete study 1 (HM20020955-1) and then 10 weeks of high intensity, normal volume exercise training
|
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 |
Experimental: Moderate Intensity, High Volume Exercise Training
Participants will complete study 1 (HM20020955-1) and then 10 weeks of moderate intensity, high volume exercise training
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline to the end of the final visit, about 14 weeks
|
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
|
Baseline to the end of the final visit, about 14 weeks
|
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
|
Baseline to the end of the final visit, about 14 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ryan Garten, PhD, Virginia Commonwealth University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HM20020955-2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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