Neural Control and Cardiac-Vascular Function in Women With PTSD (VA Psychological Assessment)
Condition: Post Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

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.
    

Intervention name(s): Exercise training and healthy eating (overseen by IEEM research team)
Intervention type(s): Behavioral
Intervention description(s): 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).
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment