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

Veterans Affairs (VA) North Texas Health Care System

Status: Completed

Conditions: Post Traumatic Stress Disorder

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

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03929939

16-061

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Lifestyle Modification Group

Experimental group

Treatment:

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

Control Group

No Intervention group