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

NCT03929939 | Completed

• 1 other identifier: 16-061
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (2)

• Muscle Sympathetic Nerve Activity (MSNA; Data collected by IEEM)

  Muscle sympathetic nerve activity will be measured using microneurography at the peroneal nerve.

  +PTSD vs. -PTSD baseline comparison; Changes from baseline following 12-week intervention

• Clinician Administered Posttraumatic Stress Disorder Scale - 5 (CAPS-5; Data collected by VANTHCS)

  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.

  Changes from baseline following 12-week intervention

Secondary Outcomes (9)

• PTSD Checklist for DSM-5 (PCL-5; Data collected by VANTHCS)

  Changes from baseline through 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

• Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF; data collected by VANTHCS)

  Changes from baseline through 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

Study Arms (2)

Lifestyle Modification Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Interventions

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

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).

Lifestyle Modification Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 18-65.
• Sedentary (exercises less than three times a week for thirty minutes or less).

You may not qualify if:

• 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.

Sponsors & Collaborators

• North Texas Veterans Healthcare System: lead
• University of Texas Southwestern Medical Center: collaborator
• Texas Health Resources: collaborator

Study Sites (2)

Dallas VA Medical Center

Dallas, Texas, 75216, United States

Location

The Institute for Exercise and Environmental Medicine

Dallas, Texas, 75231, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Exercise; Diet, Healthy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Geetha Shivakumar, MD, MS

  Dallas VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: April 29, 2019
• Study Start: March 27, 2017
• Primary Completion: January 9, 2018
• Study Completion: January 9, 2018
• Last Updated: September 30, 2022

Record last verified: 2022-09

Locations

US (2)