Posttraumatic Stress DisorderNCT01892033
A Pilot Exercise Study for PTSD in Women Veterans
A study testing Aerobic Exercise in people with Posttraumatic Stress Disorder, run by North Texas Veterans Healthcare System at 1 site in United States.
Trial summary
The overall aim of this pilot feasibility study is to determine if 12-week moderate intensity exercise can safely alleviate posttraumatic symptoms in premenopausal women veterans. Specific aims of the study are to; 1. Determine the feasibility, safety, and tolerability of 12-week moderate intensity exercise 2. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Aerobic Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Sep 2013
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women veterans ages 18 and older
- Premenopausal women of childbearing potential with a negative pregnancy test
- DSM IV-TR confirmed PTSD related to any traumatic event as measured by Clinician Administered PTSD Scale (CAPS) with a CAPS score of at least 45
- Relatively low sedentary life style
- Existing psychotropic medications are allowed if on a stable dose
- Evidence-based psychotherapy (e.g. Cognitive Processing Therapy or Prolonged Exposure) is not allowed to start of the study. However supportive or educational groups that are not PTSD-focused are allowed.
Who cannot join
- Other psychiatric diagnoses including bipolar disorder, schizophrenia, schizoaffective disorder, active substance dependence/abuse (use in the past 1 month), obsessive-compulsive disorder, and eating disorders.Comorbid major depressive disorder, dysthymia and generalized anxiety disorders are not excluded.
- Serious psychopathology
- Actively suicidal or homicidal
- Psychiatric hospitalization within the past 30 days
- Active medical conditions that preclude the use of aerobic exercise such as uncontrolled hypertension, active musculoskeletal degenerative conditions, and symptomatic cardiovascular or respiratory conditions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aerobic Exercise: Feasibility and Safety Assessment in Women Veterans With PTSD (AESAP)
The overall aim of this pilot feasibility study is to determine if 12-week moderate intensity exercise can safely alleviate posttraumatic symptoms in premenopausal women veterans.
Specific aims of the study are to;
- Determine the feasibility, safety, and tolerability of 12-week moderate intensity exercise
- Explore potential therapeutic benefits of 12-week moderate intensity exercise. Outcome data will include posttraumatic and depressive symptoms.
- Explore potential therapeutic effects of a 12-week moderate intensity exercise on comorbid pain syndrome and quality of life.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Aerobic Exercise
- Keywords
- Posttraumatic Stress Disorder, PTSD, Aerobic Exercise, Women, Veteran
- 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.
Aerobic ExerciseBehavioural
12 weeks of brisk walking
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise | Experimental | The aerobic exercise intervention is a 12-week program consisting of four 30- to 40-minute exercise sessions of brisk walking per week. Receives: Behavioral: Aerobic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Administered Posttraumatic Stress Disorder Scale (CAPS)
Measured: Changes from baseline to week 12.
Secondary outcomes (5)
PTSD Checklist
Measured: Changes from baseline to week 12.
Inventory of Depressive Symptomatology (Self-Report) (IDS-SR)
Measured: Changes from baseline to week 12.
Pain Scale
Measured: Changes from baseline to week 12.
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Measured: Changes from baseline to week 12.
Safety (Monitoring for common side effects associated with aerobic exercise and adverse events).
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2013 (estimated)
- Study startAug 2011
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Texas Veterans Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Geetha Shivakumar, North Texas Veterans Healthcare System
- Investigators
- Geetha Shivakumar, M.D., M.S., Principal investigator, Dallas VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01892033
- Sponsor's protocol ID
- 10N17
- Status last verified
- Apr 2019
- First submitted
- 28 Jun 2013
- Last updated
- 26 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Shivakumar G, Anderson EH, Suris AM, North CS. Exercise for PTSD in Women Veterans: A Proof-of-Concept Study. Mil Med. 2017 Nov;182(11):e1809-e1814. doi: 10.7205/MILMED-D-16-00440.
PubMed 29087845
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerobic Exercise: Feasibility and Safety Assessment in Women Veterans With PTSD (AESAP)
- ClinicalTrials.gov ID
- NCT01892033
- Acronym / sponsor ID
- 10N17
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- Posttraumatic Stress Disorder, PTSD, Aerobic Exercise, Women, Veteran
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- North Texas Veterans Healthcare SystemUS federal agency
- Study start
- Aug 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 3 Jul 2013 (estimated)
- 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 overall aim of this pilot feasibility study is to determine if 12-week moderate intensity exercise can safely alleviate posttraumatic symptoms in premenopausal women veterans.
Specific aims of the study are to;
- Determine the feasibility, safety, and tolerability of 12-week moderate intensity exercise
- Explore potential therapeutic benefits of 12-week moderate intensity exercise. Outcome data will include posttraumatic and depressive symptoms.
- Explore potential therapeutic effects of a 12-week moderate intensity exercise on comorbid pain syndrome and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise | Experimental | Behavioral: Aerobic ExerciseThe aerobic exercise intervention is a 12-week program consisting of four 30- to 40-minute exercise sessions of brisk walking per week. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women veterans ages 18 and older
- Premenopausal women of childbearing potential with a negative pregnancy test
- DSM IV-TR confirmed PTSD related to any traumatic event as measured by Clinician Administered PTSD Scale (CAPS) with a CAPS score of at least 45
- Relatively low sedentary life style
- Existing psychotropic medications are allowed if on a stable dose
Key exclusion criteria (5 listed)
- Other psychiatric diagnoses including bipolar disorder, schizophrenia, schizoaffective disorder, active substance dependence/abuse (use in the past 1 month), obsessive-compulsive disorder, and eating disorders.Comorbid major depressive disorder, dysthymia and generalized anxiety disorders are not excluded.
- Serious psychopathology
- Actively suicidal or homicidal
- Psychiatric hospitalization within the past 30 days
- Active medical conditions that preclude the use of aerobic exercise such as uncontrolled hypertension, active musculoskeletal degenerative conditions, and symptomatic cardiovascular or respiratory conditions.
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 |
|---|---|---|
| Aerobic Exercise12 weeks of brisk walking | Behavioural | Aerobic Exercise |
Primary outcome
Clinician Administered Posttraumatic Stress Disorder Scale (CAPS)
Time frame: Changes from baseline to week 12.
5 secondary outcomes
PTSD Checklist
Time frame: Changes from baseline to week 12.
Inventory of Depressive Symptomatology (Self-Report) (IDS-SR)
Time frame: Changes from baseline to week 12.
Pain Scale
Time frame: Changes from baseline to week 12.
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Time frame: Changes from baseline to week 12.
Safety (Monitoring for common side effects associated with aerobic exercise and adverse events).
Time frame: 12 Weeks
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 26 Apr 2019.
- Results publication: PubMed 29087845Shivakumar G, Anderson EH, Suris AM, North CS. Exercise for PTSD in Women Veterans: A Proof-of-Concept Study. Mil Med. 2017 Nov;182(11):e1809-e1814. doi: 10.7205/MILMED-D-16-00440.
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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, M.D., M.S. principal investigator
Dallas VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise in people with Posttraumatic Stress Disorder, run by North Texas Veterans Healthcare System at 1 site 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 6 inclusion and 5 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 26 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Clinician Administered Posttraumatic Stress Disorder Scale (CAPS) (time frame: Changes from baseline to week 12.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01892033, which also lists 1 linked publication.
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 26 Apr 2019.