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A Pilot Exercise Study for PTSD in Women Veterans

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ClinicalTrials.gov Identifier: NCT01892033
Recruitment Status : Completed
First Posted : July 3, 2013
Last Update Posted : September 25, 2014
Information provided by (Responsible Party):
Geetha Shivakumar, North Texas Veterans Healthcare System

Brief 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. Explore potential therapeutic benefits of 12-week moderate intensity exercise. Outcome data will include posttraumatic and depressive symptoms.
  3. Explore potential therapeutic effects of a 12-week moderate intensity exercise on comorbid pain syndrome and quality of life.

Condition or disease Intervention/treatment
Posttraumatic Stress Disorder Behavioral: Aerobic Exercise

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Aerobic Exercise: Feasibility and Safety Assessment in Women Veterans With PTSD (AESAP)
Study Start Date : August 2011
Primary Completion Date : September 2013
Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.
Behavioral: Aerobic Exercise
12 weeks of brisk walking

Primary Outcome Measures :
  1. Clinician Administered Posttraumatic Stress Disorder Scale (CAPS) [ Time Frame: Changes from baseline to week 12. ]

Secondary Outcome Measures :
  1. PTSD Checklist [ Time Frame: Changes from baseline to week 12. ]
  2. Inventory of Depressive Symptomatology (Self-Report) (IDS-SR) [ Time Frame: Changes from baseline to week 12. ]
  3. Pain Scale [ Time Frame: Changes from baseline to week 12. ]
  4. Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) [ Time Frame: Changes from baseline to week 12. ]
  5. Safety (Monitoring for common side effects associated with aerobic exercise and adverse events). [ Time Frame: 12 Weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Women veterans ages 18 and older
  2. Premenopausal women of childbearing potential with a negative pregnancy test
  3. 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
  4. Relatively low sedentary life style
  5. Existing psychotropic medications are allowed if on a stable dose
  6. 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:

  1. 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.
  2. Serious psychopathology
  3. Actively suicidal or homicidal
  4. Psychiatric hospitalization within the past 30 days
  5. Active medical conditions that preclude the use of aerobic exercise such as uncontrolled hypertension, active musculoskeletal degenerative conditions, and symptomatic cardiovascular or respiratory conditions.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01892033

United States, Texas
Dallas VA Medical Center
Dallas, Texas, United States, 75216
Sponsors and Collaborators
North Texas Veterans Healthcare System
Principal Investigator: Geetha Shivakumar, M.D., M.S. Dallas VA Medical Center

Responsible Party: Geetha Shivakumar, Psychiatrist, Dallas VA Medical Center; Assistant Professor, UT Southwestern Medical Center, North Texas Veterans Healthcare System
ClinicalTrials.gov Identifier: NCT01892033     History of Changes
Other Study ID Numbers: 10N17
First Posted: July 3, 2013    Key Record Dates
Last Update Posted: September 25, 2014
Last Verified: September 2014

Keywords provided by Geetha Shivakumar, North Texas Veterans Healthcare System:
Posttraumatic Stress Disorder
Aerobic Exercise

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders