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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03929939
Study type Interventional
Source North Texas Veterans Healthcare System
Contact
Status Completed
Phase N/A
Start date March 27, 2017
Completion date January 9, 2018

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