Neural Control and Cardiac-Vascular Function in Women With PTSD (VA Psychological Assessment)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Post Traumatic Stress Disorder
- Sponsor
- North Texas Veterans Healthcare System
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- Muscle Sympathetic Nerve Activity (MSNA; Data collected by IEEM)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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.
Detailed Description
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.
Investigators
Geetha Shivakumar
Principal Investigator
North Texas Veterans Healthcare System
Eligibility Criteria
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-
- •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.
Outcomes
Primary Outcomes
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.
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
- Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF; data collected by VANTHCS)(Changes from baseline through 12-week intervention)
- Endothelial function (data collected by IEEM)(+PTSD vs. -PTSD baseline comparison; Changes from baseline following 12-week intervention)
- PTSD Checklist for DSM-5 (PCL-5; Data collected by VANTHCS)(Changes from baseline through 12-week intervention)
- Physical Fitness (Data collected by IEEM)(Changes from baseline following 12-week intervention)
- Systolic and diastolic cardiac function (Data collected by IEEM)(+PTSD vs. -PTSD baseline comparison; Changes from baseline following 12-week intervention)
- 36-Item Short Form Health Survey (SF-36; Data collected by IEEM)(+PTSD vs. -PTSD baseline comparison; Changes from baseline following 12-week intervention)
- Arterial stiffness (Data collected by IEEM)(+PTSD vs. -PTSD baseline comparison; Changes from baseline following 12-week intervention)
- Quick Inventory for Depressive Symptomatology-self report (QIDS- SR16; Data collected by VANTHCS)(Changes from baseline through 12-week intervention)
- Concise Health Risk Tracking Scale - self-report module (CHRT; data collected by VANTHCS)(Changes from baseline through 12-week intervention)