Clinical trial NCT03929939: Neural Control and Cardiac-Vascular Function in Women With PTSD (VA Psychological Assessment)
Official title: Neural Control and Cardiac-Vascular Function in Women With PTSD (VA Psychological Assessment)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Lead sponsor: North Texas Veterans Healthcare System
Sponsor class: FED
Collaborators: name: University of Texas Southwestern Medical Center
name: Texas Health Resources
First posted: 2019-04-29
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. 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).
2. Be between the ages of 18-65.
3. Sedentary (exercises less than three times a week for thirty minutes or less).

Exclusion Criteria:

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

Primary outcomes:
measure: Muscle Sympathetic Nerve Activity (MSNA; Data collected by IEEM)
timeFrame: +PTSD vs. -PTSD baseline comparison; Changes from baseline following 12-week intervention
measure: Clinician Administered Posttraumatic Stress Disorder Scale - 5 (CAPS-5; Data collected by VANTHCS)
timeFrame: Changes from baseline following 12-week intervention
Secondary outcomes:
measure: PTSD Checklist for DSM-5 (PCL-5; Data collected by VANTHCS)
timeFrame: Changes from baseline through 12-week intervention
measure: Quick Inventory for Depressive Symptomatology-self report (QIDS- SR16; Data collected by VANTHCS)
timeFrame: Changes from baseline through 12-week intervention
measure: Concise Health Risk Tracking Scale - self-report module (CHRT; data collected by VANTHCS)
timeFrame: Changes from baseline through 12-week intervention
measure: Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF; data collected by VANTHCS)
timeFrame: Changes from baseline through 12-week intervention
measure: 36-Item Short Form Health Survey (SF-36; Data collected by IEEM)
timeFrame: +PTSD vs. -PTSD baseline comparison; Changes from baseline following 12-week intervention
measure: Endothelial function (data collected by IEEM)
timeFrame: +PTSD vs. -PTSD baseline comparison; Changes from baseline following 12-week intervention
measure: Arterial stiffness (Data collected by IEEM)
timeFrame: +PTSD vs. -PTSD baseline comparison; Changes from baseline following 12-week intervention
measure: Systolic and diastolic cardiac function (Data collected by IEEM)
timeFrame: +PTSD vs. -PTSD baseline comparison; Changes from baseline following 12-week intervention
measure: Physical Fitness (Data collected by IEEM)
timeFrame: Changes from baseline following 12-week intervention
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Dallas VA Medical Center
state: Texas
city: Dallas
country: United States
facility: The Institute for Exercise and Environmental Medicine
state: Texas
Study officials:
affiliation: Dallas VA Medical Center
name: Geetha Shivakumar, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: