Examining the Impact of Exercise Training on Vascular Dysfunction in Individuals With Mental Health Disorders - Study 3

Sponsor
Virginia Commonwealth University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04916340
Collaborator
(none)
240
1
2
20.2
11.9

Study Details

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)).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Muscular Strength Training Group
  • Behavioral: Muscular Fitness Training Group
N/A

Detailed Description

Study #3 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 two weight lifting programs that differ based on the amount of weight lifted (heavy vs moderate weight).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Examining the Impact of Exercise Training on Vascular Dysfunction in Individuals With Mental Health Disorders - Study 3
Actual Study Start Date :
Jan 24, 2022
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Muscular Strength

Participants will complete study 1 (HM20020955-1) and then 10 weeks of resistance training for muscular strength

Behavioral: Muscular Strength Training Group
Week 1 3 days/week Bench Press - 1 set at 80% of one repetition maximum (1RM) Bent Over Row - 1 set at 80% 1RM Back Squat - 1 set at 80% 1RM Romanian Deadlift - 1 set at 80% 1RM Week 2 3 days/week Bench Press - 2 sets at 80% 1RM Bent Over Row - 2 sets at 80% 1RM Back Squat - 2 sets at 80% 1RM Romanian Deadlift - 2 sets at 80% 1RM Weeks 3-10 3 days/week Bench Press - 3 sets at 80% 1RM Bent Over Row - 3 sets at 80% 1RM Back Squat - 3 sets at 80% 1RM Romanian Deadlift - 3 sets at 80% 1RM

Experimental: Muscular fitness

Participants will complete study 1 (HM20020955-1) and then 10 weeks of resistance training for muscular fitness

Behavioral: Muscular Fitness Training Group
Week 1 3 days/week Bench Press - 1 set at 65% 1RM Bent Over Row - 1 set at 65% 1RM Back Squat - 1 set at 65% 1RM Romanian Deadlift - 1 set at 65% 1RM Week 2 3 days/week Bench Press - 2 sets at 65% 1RM Bent Over Row - 2 sets at 65% 1RM Back Squat - 2 sets at 65% 1RM Romanian Deadlift - 2 sets at 65% 1RM Weeks 3-10 3 days/week Bench Press - 3 sets at 65% 1RM Bent Over Row - 3 sets at 65% 1RM Back Squat - 3 sets at 65% 1RM Romanian Deadlift - 3 sets at 65% 1RM

Outcome Measures

Primary Outcome Measures

  1. Arm Vascular Function at Rest (Flow Mediated Dilation Test) [Baseline to the end of the final visit, about 14 weeks]

    Change in Brachial Artery Dilation from Baseline Values

  2. Leg Vascular Function (Passive Leg Movement Test) [Baseline to the end of the final visit, about 14 weeks]

    Change in Leg Blood Flow Values from Baseline

  3. Arm Vascular Function in Response to Exercise (Handgrip Exercise Test) [Baseline to the end of the final visit, about 14 weeks]

    Change in Brachial Artery Dilation from Baseline Values

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Virginia Commonwealth University Richmond Virginia United States 23298

Sponsors and Collaborators

  • Virginia Commonwealth University

Investigators

  • Principal Investigator: Ryan Garten, PhD, Virginia Commonwealth University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT04916340
Other Study ID Numbers:
  • HM20020955-3
First Posted:
Jun 7, 2021
Last Update Posted:
Aug 3, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Virginia Commonwealth University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 3, 2022