Post Traumatic Stress DisorderNCT03929939
Neural Control and Cardiac-Vascular Function in Women With PTSD (VA Psychological Assessment)
A study testing Exercise training and healthy eating (overseen by IEEM research team) in people with Post Traumatic Stress Disorder, run by North Texas Veterans Healthcare System at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Exercise training and healthy eating (overseen by IEEM research team)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Mar 2017to 9 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dallas VA Medical Center
Dallas, Texas, 75216
The Institute for Exercise and Environmental Medicine
Dallas, Texas, 75231
About this study
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.
Read the 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.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Exercise training and healthy eating (overseen by IEEM research team)
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise training and healthy eating (overseen by IEEM research team)Behavioural
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 group | Role | What they receive |
|---|---|---|
| Lifestyle Modification Group | Experimental | Not described Receives: Behavioral: Exercise training and healthy eating (overseen by IEEM research team) |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Sympathetic Nerve Activity (MSNA; Data collected by IEEM)
Muscle sympathetic nerve activity will be measured using microneurography at the peroneal nerve.
Measured: +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.
Measured: Changes from baseline following 12-week intervention
Secondary outcomes (9)
PTSD Checklist for DSM-5 (PCL-5; Data collected by VANTHCS)
Self-report measure of PTSD symptoms
Measured: Changes from baseline through 12-week intervention
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.
Measured: Changes from baseline through 12-week intervention
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.
Measured: Changes from baseline through 12-week intervention
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.
Measured: Changes from baseline through 12-week intervention
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].
Measured: +PTSD vs. -PTSD baseline comparison; Changes from baseline following 12-week intervention
Endothelial function (data collected by IEEM)
Measured using flow-mediated vasodilation
Measured: +PTSD vs. -PTSD baseline comparison; Changes from baseline following 12-week intervention
Arterial stiffness (Data collected by IEEM)
Central and peripheral pulse wave velocity measured using arterial tonometry
Measured: +PTSD vs. -PTSD baseline comparison; Changes from baseline following 12-week intervention
Systolic and diastolic cardiac function (Data collected by IEEM)
Measured using echocardiogram
Measured: +PTSD vs. -PTSD baseline comparison; Changes from baseline following 12-week intervention
Physical Fitness (Data collected by IEEM)
Peak oxygen uptake (Douglas bag method) during submaximal and maximal treadmill test
Measured: Changes from baseline following 12-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start27 Mar 2017
- Primary completion9 Jan 2018
- Study completion9 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Texas Veterans Healthcare System
- Sponsor type
- US federal agency
- Collaborators
- University of Texas Southwestern Medical Center, Texas Health Resources
- Responsible party
- Principal investigator, Geetha Shivakumar, North Texas Veterans Healthcare System
- Investigators
- Geetha Shivakumar, MD, MS, Principal investigator, Dallas VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03929939
- Sponsor's protocol ID
- 16-061
- Status last verified
- Sep 2022
- First submitted
- 24 Apr 2019
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Control and Cardiac-Vascular Function in Women With PTSD (VA Psychological Assessment)
- ClinicalTrials.gov ID
- NCT03929939
- Acronym / sponsor ID
- 16-061
- Conditions
- Post Traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- North Texas Veterans Healthcare SystemUS federal agency
- Collaborators
- University of Texas Southwestern Medical Center, Texas Health Resources
- Study start
- 27 Mar 2017 (actual)
- Primary completion
- 9 Jan 2018 (actual)
- Study completion
- 9 Jan 2018 (actual)
- First posted
- 29 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Modification Group | Experimental | Behavioral: Exercise training and healthy eating (overseen by IEEM research team) |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise training and healthy eating (overseen by IEEM research team)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). | Behavioural | Lifestyle Modification Group |
Primary outcome
Muscle Sympathetic Nerve Activity (MSNA; Data collected by IEEM)
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; Data collected by VANTHCS)
Time frame: Changes from baseline following 12-week intervention
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.
9 secondary outcomes
PTSD Checklist for DSM-5 (PCL-5; Data collected by VANTHCS)
Time frame: Changes from baseline through 12-week intervention
Quick Inventory for Depressive Symptomatology-self report (QIDS- SR16; Data collected by VANTHCS)
Time frame: Changes from baseline through 12-week intervention
Concise Health Risk Tracking Scale - self-report module (CHRT; data collected by VANTHCS)
Time frame: Changes from baseline through 12-week intervention
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF; data collected by VANTHCS)
Time frame: Changes from baseline through 12-week intervention
36-Item Short Form Health Survey (SF-36; Data collected by IEEM)
Time frame: +PTSD vs. -PTSD baseline comparison; Changes from baseline following 12-week intervention
Endothelial function (data collected by IEEM)
Time frame: +PTSD vs. -PTSD baseline comparison; Changes from baseline following 12-week intervention
Arterial stiffness (Data collected by IEEM)
Time frame: +PTSD vs. -PTSD baseline comparison; Changes from baseline following 12-week intervention
Systolic and diastolic cardiac function (Data collected by IEEM)
Time frame: +PTSD vs. -PTSD baseline comparison; Changes from baseline following 12-week intervention
Physical Fitness (Data collected by IEEM)
Time frame: Changes from baseline following 12-week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geetha Shivakumar, MD, MS principal investigator
Dallas VA Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training and healthy eating (overseen by IEEM research team) in people with Post Traumatic Stress Disorder, run by North Texas Veterans Healthcare System at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Sympathetic Nerve Activity (MSNA; Data collected by IEEM) (time frame: +PTSD vs. -PTSD baseline comparison; Changes from baseline following 12-week intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2022.