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

Peripheral Vascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04922762
• Other study ID #: HM20020955-2
• Status: Recruiting
• Phase: N/A
• Start date: December 6, 2021
• Est. completion date: October 2024

Study information

• Verified date: August 2023
• Source: Virginia Commonwealth University
• Contact: Ryan Garten, PhD
• Phone: (804) 828-1948
• Email: rsgarten[@]vcu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Behavioral:
• 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
• 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
• 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

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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