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

Primary Purpose

Post Traumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise training and healthy eating (overseen by IEEM research team)
Sponsored by
North Texas Veterans Healthcare System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Traumatic Stress Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts 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.

Sites / Locations

  • Dallas VA Medical Center
  • The Institute for Exercise and Environmental Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Lifestyle Modification Group

Control Group

Arm Description

Outcomes

Primary Outcome Measures

Muscle Sympathetic Nerve Activity (MSNA; Data collected by IEEM)
Muscle sympathetic nerve activity will be measured using microneurography at the peroneal nerve.
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.

Secondary Outcome Measures

PTSD Checklist for DSM-5 (PCL-5; Data collected by VANTHCS)
Self-report measure of PTSD symptoms
Quick Inventory for Depressive Symptomatology-self report (QIDS- SR16; Data collected by VANTHCS)
Self-report measure of depression symptom severity. Total scores range from 0-27. A higher score indicates greater symptom severity.
Concise Health Risk Tracking Scale - self-report module (CHRT; data collected by VANTHCS)
The CHRT-SR is a 16-item self-report measure that assesses suicidal propensity and risk. All items are scored on a 5-point Likert scale ranging from "strongly disagree" (0) to "strongly agree" (4). The propensity score (items 1-13) assesses pessimism, helplessness, perceived lack of social support, and despair. The propensity score may range from 0 to 52, with higher scores showing higher levels of suicidal propensity. The risk score (items 14-16) assess thoughts and plans of killing oneself. The risk score may range from 0-12, with a higher score showing higher levels of suicidal thoughts.
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF; data collected by VANTHCS)
The Q-LES-Q-SF is a 16 item self-report measure that assesses perceived quality of life. All items are scored on a 5-point Likert scale ranging from "very poor" (1) to "very good" (5). raw total score is created by summing the first 14 items. The last two items are standalone items and not included in the total score. Raw total score ranges from 14-70. The raw total score is transformed into a percentage maximum possible score using the following formula: (raw total score - minimum score)/(maximum possible raw score-minimum score). Percentage maximum ranges from 0% to 100, with a lower percentage indicating worse perceived quality of life.
36-Item Short Form Health Survey (SF-36; Data collected by IEEM)
The SF-36 is a 36-item self-report measure of general health status. The measure includes multi-item scales to measure the following 8 dimensions: physical functioning; role limitations due to physical health problems; bodily pain; social functioning; general mental health; role limitations due to emotional problems; vitality, energy, or fatigue; and general health perceptions. All items are scored so that a higher score indicates a more favorable health state. The SF-36 produces two sets of scores: a profile of eight sections scores, and two summary scores (physical component scores [PCS] and mental component scores [MCS].
Endothelial function (data collected by IEEM)
Measured using flow-mediated vasodilation
Arterial stiffness (Data collected by IEEM)
Central and peripheral pulse wave velocity measured using arterial tonometry
Systolic and diastolic cardiac function (Data collected by IEEM)
Measured using echocardiogram
Physical Fitness (Data collected by IEEM)
Peak oxygen uptake (Douglas bag method) during submaximal and maximal treadmill test

Full Information

First Posted
April 24, 2019
Last Updated
September 28, 2022
Sponsor
North Texas Veterans Healthcare System
Collaborators
University of Texas Southwestern Medical Center, Texas Health Resources
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1. Study Identification

Unique Protocol Identification Number
NCT03929939
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
March 27, 2017 (Actual)
Primary Completion Date
January 9, 2018 (Actual)
Study Completion Date
January 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
North Texas Veterans Healthcare System
Collaborators
University of Texas Southwestern Medical Center, Texas Health Resources

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle Modification Group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Exercise training and healthy eating (overseen by IEEM research team)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Muscle Sympathetic Nerve Activity (MSNA; Data collected by IEEM)
Description
Muscle sympathetic nerve activity will be measured using microneurography at the peroneal nerve.
Time Frame
+PTSD vs. -PTSD baseline comparison; Changes from baseline following 12-week intervention
Title
Clinician Administered Posttraumatic Stress Disorder Scale - 5 (CAPS-5; Data collected by VANTHCS)
Description
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.
Time Frame
Changes from baseline following 12-week intervention
Secondary Outcome Measure Information:
Title
PTSD Checklist for DSM-5 (PCL-5; Data collected by VANTHCS)
Description
Self-report measure of PTSD symptoms
Time Frame
Changes from baseline through 12-week intervention
Title
Quick Inventory for Depressive Symptomatology-self report (QIDS- SR16; Data collected by VANTHCS)
Description
Self-report measure of depression symptom severity. Total scores range from 0-27. A higher score indicates greater symptom severity.
Time Frame
Changes from baseline through 12-week intervention
Title
Concise Health Risk Tracking Scale - self-report module (CHRT; data collected by VANTHCS)
Description
The CHRT-SR is a 16-item self-report measure that assesses suicidal propensity and risk. All items are scored on a 5-point Likert scale ranging from "strongly disagree" (0) to "strongly agree" (4). The propensity score (items 1-13) assesses pessimism, helplessness, perceived lack of social support, and despair. The propensity score may range from 0 to 52, with higher scores showing higher levels of suicidal propensity. The risk score (items 14-16) assess thoughts and plans of killing oneself. The risk score may range from 0-12, with a higher score showing higher levels of suicidal thoughts.
Time Frame
Changes from baseline through 12-week intervention
Title
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF; data collected by VANTHCS)
Description
The Q-LES-Q-SF is a 16 item self-report measure that assesses perceived quality of life. All items are scored on a 5-point Likert scale ranging from "very poor" (1) to "very good" (5). raw total score is created by summing the first 14 items. The last two items are standalone items and not included in the total score. Raw total score ranges from 14-70. The raw total score is transformed into a percentage maximum possible score using the following formula: (raw total score - minimum score)/(maximum possible raw score-minimum score). Percentage maximum ranges from 0% to 100, with a lower percentage indicating worse perceived quality of life.
Time Frame
Changes from baseline through 12-week intervention
Title
36-Item Short Form Health Survey (SF-36; Data collected by IEEM)
Description
The SF-36 is a 36-item self-report measure of general health status. The measure includes multi-item scales to measure the following 8 dimensions: physical functioning; role limitations due to physical health problems; bodily pain; social functioning; general mental health; role limitations due to emotional problems; vitality, energy, or fatigue; and general health perceptions. All items are scored so that a higher score indicates a more favorable health state. The SF-36 produces two sets of scores: a profile of eight sections scores, and two summary scores (physical component scores [PCS] and mental component scores [MCS].
Time Frame
+PTSD vs. -PTSD baseline comparison; Changes from baseline following 12-week intervention
Title
Endothelial function (data collected by IEEM)
Description
Measured using flow-mediated vasodilation
Time Frame
+PTSD vs. -PTSD baseline comparison; Changes from baseline following 12-week intervention
Title
Arterial stiffness (Data collected by IEEM)
Description
Central and peripheral pulse wave velocity measured using arterial tonometry
Time Frame
+PTSD vs. -PTSD baseline comparison; Changes from baseline following 12-week intervention
Title
Systolic and diastolic cardiac function (Data collected by IEEM)
Description
Measured using echocardiogram
Time Frame
+PTSD vs. -PTSD baseline comparison; Changes from baseline following 12-week intervention
Title
Physical Fitness (Data collected by IEEM)
Description
Peak oxygen uptake (Douglas bag method) during submaximal and maximal treadmill test
Time Frame
Changes from baseline following 12-week intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geetha Shivakumar, MD, MS
Organizational Affiliation
Dallas VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dallas VA Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
The Institute for Exercise and Environmental Medicine
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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