4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Neural Control and Cardiac-Vascular Function in Women With PTSD

Neural Control and Cardiac-Vascular Function in Women With PTSD

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.

Condition or disease Intervention/treatment Phase
Post Traumatic Stress Disorder Behavioral: Exercise training and healthy eating Not Applicable

Detailed Description:
This is a collaborative study between VA North Texas Healthcare System (VANTHCS), University of Texas Southwestern Medical Center (UTSW), and Texas Health Resources. VANTHCS researchers will be responsible for recruitment of women veterans with PTSD and psychological assessments. UTSW/Texas Health Resources researchers will be responsible for recruitment of non-veteran women without a diagnosis of PTSD, physiological assessments, and the lifestyle modification intervention.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neural Control and Cardiac-Vascular Function in Women With PTSD
Actual Study Start Date : March 27, 2017
Actual Primary Completion Date : January 9, 2018
Actual Study Completion Date : January 9, 2018
Arms and Interventions
Arm Intervention/treatment
Experimental: Lifestyle Modification Group Behavioral: Exercise training and healthy eating

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).
No Intervention: Control Group
Outcome Measures
Primary Outcome Measures :
  1. Muscle Sympathetic Nerve Activity (MSNA) [ Time Frame: +PTSD vs. -PTSD baseline comparison; Changes from baseline following 12-week intervention ]
    Muscle sympathetic nerve activity will be measured using microneurography at the peroneal nerve.

  2. Clinician Administered Posttraumatic Stress Disorder Scale - 5 (CAPS-5) [ Time Frame: Changes from baseline following 12-week intervention ]
    Used to confirm PTSD diagnosis and assess severity of symptoms


Secondary Outcome Measures :
  1. PTSD Checklist for DSM-5(PCL) [ Time Frame: Changes from baseline through 12-week intervention ]
    Self-report measure of PTSD symptoms

  2. Quick Inventory for Depressive Symptomatology (QIDS-16) [ Time Frame: Changes from baseline through 12-week intervention ]
    Self-report measure of symptoms of depression

  3. Concise Health Risk Tracking Scale (CHRT) - self-report module [ Time Frame: Changes from baseline through 12-week intervention ]
    Suicidality measure

  4. Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) [ Time Frame: Changes from baseline through 12-week intervention ]
    Quality of life measure

  5. 36-Item Short Form Health Survey [ Time Frame: +PTSD vs. -PTSD baseline comparison; Changes from baseline following 12-week intervention ]
    Health-related quality of life measure

  6. Endothelial function [ Time Frame: +PTSD vs. -PTSD baseline comparison; Changes from baseline following 12-week intervention ]
    Measured using flow-mediated vasodilation

  7. Arterial stiffness [ Time Frame: +PTSD vs. -PTSD baseline comparison; Changes from baseline following 12-week intervention ]
    Central and peripheral pulse wave velocity measured using arterial tonometry

  8. Systolic and diastolic cardiac function [ Time Frame: +PTSD vs. -PTSD baseline comparison; Changes from baseline following 12-week intervention ]
    Measured using echocardiogram

  9. Physical Fitness [ Time Frame: Changes from baseline following 12-week intervention ]
    Peak oxygen uptake (Douglas bag method) during submaximal and maximal treadmill test


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations

Locations
Layout table for location information
United States, Texas
Dallas VA Medical Center
Dallas, Texas, United States, 75216
The Institute for Exercise and Environmental Medicine
Dallas, Texas, United States, 75231
Sponsors and Collaborators
North Texas Veterans Healthcare System
University of Texas Southwestern Medical Center
Texas Health Resources
Investigators
Layout table for investigator information
Principal Investigator: Geetha Shivakumar, MD, MS Dallas VA Medical Center
Tracking Information
First Submitted Date  ICMJE April 24, 2019
First Posted Date  ICMJE April 29, 2019
Last Update Posted Date April 29, 2019
Actual Study Start Date  ICMJE March 27, 2017
Actual Primary Completion Date January 9, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2019)
  • Muscle Sympathetic Nerve Activity (MSNA) [ Time Frame: +PTSD vs. -PTSD baseline comparison; Changes from baseline following 12-week intervention ]
    Muscle sympathetic nerve activity will be measured using microneurography at the peroneal nerve.
  • Clinician Administered Posttraumatic Stress Disorder Scale - 5 (CAPS-5) [ Time Frame: Changes from baseline following 12-week intervention ]
    Used to confirm PTSD diagnosis and assess severity of symptoms
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2019)
  • PTSD Checklist for DSM-5(PCL) [ Time Frame: Changes from baseline through 12-week intervention ]
    Self-report measure of PTSD symptoms
  • Quick Inventory for Depressive Symptomatology (QIDS-16) [ Time Frame: Changes from baseline through 12-week intervention ]
    Self-report measure of symptoms of depression
  • Concise Health Risk Tracking Scale (CHRT) - self-report module [ Time Frame: Changes from baseline through 12-week intervention ]
    Suicidality measure
  • Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) [ Time Frame: Changes from baseline through 12-week intervention ]
    Quality of life measure
  • 36-Item Short Form Health Survey [ Time Frame: +PTSD vs. -PTSD baseline comparison; Changes from baseline following 12-week intervention ]
    Health-related quality of life measure
  • Endothelial function [ Time Frame: +PTSD vs. -PTSD baseline comparison; Changes from baseline following 12-week intervention ]
    Measured using flow-mediated vasodilation
  • Arterial stiffness [ Time Frame: +PTSD vs. -PTSD baseline comparison; Changes from baseline following 12-week intervention ]
    Central and peripheral pulse wave velocity measured using arterial tonometry
  • Systolic and diastolic cardiac function [ Time Frame: +PTSD vs. -PTSD baseline comparison; Changes from baseline following 12-week intervention ]
    Measured using echocardiogram
  • Physical Fitness [ Time Frame: Changes from baseline following 12-week intervention ]
    Peak oxygen uptake (Douglas bag method) during submaximal and maximal treadmill test
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neural Control and Cardiac-Vascular Function in Women With PTSD
Official Title  ICMJE Neural Control and Cardiac-Vascular Function in Women With PTSD
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 VA North Texas Healthcare System (VANTHCS), University of Texas Southwestern Medical Center (UTSW), and Texas Health Resources. VANTHCS researchers will be responsible for recruitment of women veterans with PTSD and psychological assessments. UTSW/Texas Health Resources researchers will be responsible for recruitment of non-veteran women without a diagnosis of PTSD, physiological assessments, and the lifestyle modification intervention.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Post Traumatic Stress Disorder
Intervention  ICMJE Behavioral: Exercise training and healthy eating

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).
Study Arms  ICMJE
  • Experimental: Lifestyle Modification Group
    Intervention: Behavioral: Exercise training and healthy eating
  • No Intervention: Control Group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 24, 2019) 		24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 9, 2018
Actual Primary Completion Date January 9, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03929939
Other Study ID Numbers  ICMJE 16-061
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Geetha Shivakumar, North Texas Veterans Healthcare System
Study Sponsor  ICMJE North Texas Veterans Healthcare System
Collaborators  ICMJE
  • University of Texas Southwestern Medical Center
  • Texas Health Resources
Investigators  ICMJE
Principal Investigator: Geetha Shivakumar, MD, MS Dallas VA Medical Center
PRS Account North Texas Veterans Healthcare System
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

新药特效药

前沿医讯