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Completed

NCT Number: NCT03929939

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

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.

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Key information

Conditions

Post Traumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dallas VA Medical Center, Dallas, Texas, United States

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About this study

This is a collaborative study between the Institute for Exercise and Environmental Medicine (IEEM; Texas Health Resources/University of Texas Southwestern medical Center) and VA North Texas Healthcare System (VANTHCS). The overall study was conceptualized and initiated by Dr. Qi Fu and her research team at the IEEM. IEEM researchers will be responsible for recruitment of non-veteran women without a diagnosis of PTSD, physiological assessments, and the lifestyle modification intervention. VANTHCS researchers will be responsible for recruitment of women veterans with PTSD and psychological assessments. The procedures taking place at VANTHCS (recruitment of women Veterans with PTSD and psychological assessments) will fall under a separate study (overseen by VANTCHS IRB and RDC) and will not include the procedures and intervention that will take place at the IEEM (which will be overseen by a separate IRB). Data will be shared between the sites per data sharing agreement. This clinical trials entry reflects the VANTHCS study. Outcome measures gathered by the IEEM research team are included in this entry due to the data sharing agreement.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Be either a female veteran with a current diagnosis of PTSD (for the PTSD group) or a female non-veteran without a current diagnosis of PTSD (for the non-PTSD control group).
  • Be between the ages of 18-65.
  • Sedentary (exercises less than three times a week for thirty minutes or less).

Exclusion criteria

  • Any evidence of cardiopulmonary and neurological diseases by history or by physical examination.
  • Chronic kidney disease (serum creatinine > 1.5 mg/dL).
  • Peripheral vascular disease.
  • Peripheral neuropathy.
  • Current substance use disorder other than tobacco related.
  • Endurance-trained athletes due to the effects of exercise training on sympathetic neural control and cardiac-vascular function.
  • Current pregnancy.

Treatment and study plan

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

Behavioral

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).

Primary outcomes

  1. Muscle Sympathetic Nerve Activity (MSNA; Data collected by IEEM)

    Time frame: +PTSD vs. -PTSD baseline comparison; Changes from baseline following 12-week intervention

    Muscle sympathetic nerve activity will be measured using microneurography at the peroneal nerve.

  2. Clinician Administered Posttraumatic Stress Disorder Scale - 5 (CAPS-5; Data collected by VANTHCS)

    Time frame: Changes from baseline following 12-week intervention

    CAPS-5 is a 30-item structured interview that corresponds to the DSM-5 diagnosis for PTSD. The instrument is used to make a current or lifetime diagnosis of PTSD, as well as assess symptom severity. Total symptom severity scores range from 0 to 80. A higher score indicates greater symptom severity. Individual symptom severity scores range from 0 (absent) to 4 (extreme/incapacitating) and are based on symptom frequency and intensity.

Secondary outcomes

  1. PTSD Checklist for DSM-5 (PCL-5; Data collected by VANTHCS)

    Time frame: Changes from baseline through 12-week intervention

    Self-report measure of PTSD symptoms

  2. Quick Inventory for Depressive Symptomatology-self report (QIDS- SR16; Data collected by VANTHCS)

    Time frame: Changes from baseline through 12-week intervention

    Self-report measure of depression symptom severity. Total scores range from 0-27. A higher score indicates greater symptom severity.

  3. Concise Health Risk Tracking Scale - self-report module (CHRT; data collected by VANTHCS)

    Time frame: Changes from baseline through 12-week intervention

    The CHRT-SR is a 16-item self-report measure that assesses suicidal propensity and risk. All items are scored on a 5-point Likert scale ranging from "strongly disagree" (0) to "strongly agree" (4). The propensity score (items 1-13) assesses pessimism, helplessness, perceived lack of social support, and despair. The propensity score may range from 0 to 52, with higher scores showing higher levels of suicidal propensity. The risk score (items 14-16) assess thoughts and plans of killing oneself. The risk score may range from 0-12, with a higher score showing higher levels of suicidal thoughts.

  4. Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF; data collected by VANTHCS)

    Time frame: Changes from baseline through 12-week intervention

    The Q-LES-Q-SF is a 16 item self-report measure that assesses perceived quality of life. All items are scored on a 5-point Likert scale ranging from "very poor" (1) to "very good" (5). raw total score is created by summing the first 14 items. The last two items are standalone items and not included in the total score. Raw total score ranges from 14-70. The raw total score is transformed into a percentage maximum possible score using the following formula: (raw total score - minimum score)/(maximum possible raw score-minimum score). Percentage maximum ranges from 0% to 100, with a lower percentage indicating worse perceived quality of life.

  5. 36-Item Short Form Health Survey (SF-36; Data collected by IEEM)

    Time frame: +PTSD vs. -PTSD baseline comparison; Changes from baseline following 12-week intervention

    The SF-36 is a 36-item self-report measure of general health status. The measure includes multi-item scales to measure the following 8 dimensions: physical functioning; role limitations due to physical health problems; bodily pain; social functioning; general mental health; role limitations due to emotional problems; vitality, energy, or fatigue; and general health perceptions. All items are scored so that a higher score indicates a more favorable health state. The SF-36 produces two sets of scores: a profile of eight sections scores, and two summary scores (physical component scores [PCS] and mental component scores [MCS].

  6. Endothelial function (data collected by IEEM)

    Time frame: +PTSD vs. -PTSD baseline comparison; Changes from baseline following 12-week intervention

    Measured using flow-mediated vasodilation

  7. Arterial stiffness (Data collected by IEEM)

    Time frame: +PTSD vs. -PTSD baseline comparison; Changes from baseline following 12-week intervention

    Central and peripheral pulse wave velocity measured using arterial tonometry

  8. Systolic and diastolic cardiac function (Data collected by IEEM)

    Time frame: +PTSD vs. -PTSD baseline comparison; Changes from baseline following 12-week intervention

    Measured using echocardiogram

  9. Physical Fitness (Data collected by IEEM)

    Time frame: Changes from baseline following 12-week intervention

    Peak oxygen uptake (Douglas bag method) during submaximal and maximal treadmill test

Sponsors and collaborators

Lead sponsor

North Texas Veterans Healthcare System

Fed

Collaborators

  • Texas Health Resources
  • University of Texas Southwestern Medical Center

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 29, 2019
Registry last updated
Sep 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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