A Pilot Exercise Study for PTSD in Women Veterans
April 24, 2019 updated by: Geetha Shivakumar, North Texas Veterans Healthcare System
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Texas
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Dallas, Texas, United States, 75216
- Dallas VA Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Aerobic Exercise
The aerobic exercise intervention is a 12-week program consisting of four 30- to 40-minute exercise sessions of brisk walking per week.
|
12 weeks of brisk walking
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Clinician Administered Posttraumatic Stress Disorder Scale (CAPS)
Time Frame: Changes from baseline to week 12.
|
Changes from baseline to week 12.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
PTSD Checklist
Time Frame: Changes from baseline to week 12.
|
Changes from baseline to week 12.
|
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Inventory of Depressive Symptomatology (Self-Report) (IDS-SR)
Time Frame: Changes from baseline to week 12.
|
Changes from baseline to week 12.
|
|
Pain Scale
Time Frame: Changes from baseline to week 12.
|
Changes from baseline to week 12.
|
|
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Time Frame: Changes from baseline to week 12.
|
Changes from baseline to week 12.
|
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Safety (Monitoring for common side effects associated with aerobic exercise and adverse events).
Time Frame: 12 Weeks
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12 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Geetha Shivakumar, M.D., M.S., Dallas VA Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2011
Primary Completion (ACTUAL)
September 1, 2013
Study Completion (ACTUAL)
September 1, 2013
Study Registration Dates
First Submitted
June 28, 2013
First Submitted That Met QC Criteria
June 28, 2013
First Posted (ESTIMATE)
July 3, 2013
Study Record Updates
Last Update Posted (ACTUAL)
April 26, 2019
Last Update Submitted That Met QC Criteria
April 24, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10N17
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.