Neural Control and Cardiac-Vascular Function in Women With PTSD (VA Psychological Assessment)

NCT03929939 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-09-30

No results posted yet for this study

Summary

The purpose of this research is 1) to investigate the role of the sympathetic nervous system and cardiac-vascular function in women with PTSD; and 2) to determine whether lifestyle modifications (exercise training and healthy eating) would be effective in reducing sympathetic activity, improving cardiovascular function, and improving psychiatric and quality of life outcomes in women with PTSD. It is hypothesized that (1) women with PTSD will have over-activation of the sympathetic nervous system and impaired cardiac-vascular function compared with women who are trauma free, and (2) lifestyle modifications can reduce sympathetic activity, improve cardiac-vascular function, and improve psychiatric symptoms and quality of life in women with PTSD.

Conditions

  • Post Traumatic Stress Disorder

Interventions

BEHAVIORAL

Exercise training and healthy eating (overseen by IEEM research team)

Exercise Training: A "personalized" training program will be developed for participants. Based on maximal steady state heart rate and resting heart rate, three training zones (recovery, base pace, and maximal steady state) will be determined. The target heart rate for each training zone will be set for each patient. The majority of training sessions during the early phase of the program will be prescribed as "base pace" with target heart rate equivalent to about 75% of maximal. Initially, patients will train 3 times per week for 20-30 minutes per session by walking, jogging or swimming. As the patients become relatively fit, the duration of the base training sessions will be prolonged, and subsequently sessions of increased intensity (i.e., maximal steady state) will be added. Healthy Eating: Participants will be provided with dietary advice consistent with the American Heart Association guidelines (D.A.S.H. diet eating plan).

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    collaborator OTHER
  • Texas Health Resources

    collaborator OTHER
  • North Texas Veterans Healthcare System

    lead FED

Principal Investigators

  • Geetha Shivakumar, MD, MS · Dallas VA Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-27
Primary Completion
2018-01-09
Completion
2018-01-09

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03929939 on ClinicalTrials.gov