A Pilot Exercise Study for PTSD in Women Veterans

Study Overview
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Brief Summary
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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.

Official Title
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Aerobic Exercise: Feasibility and Safety Assessment in Women Veterans With PTSD (AESAP)

Conditions
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Posttraumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Aerobic Exercise


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aerobic Exercise<br>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<br>* 12 weeks of brisk walking<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician Administered Posttraumatic Stress Disorder Scale (CAPS) |  | Changes from baseline to week 12. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD Checklist |  | Changes from baseline to week 12. | 
| Inventory of Depressive Symptomatology (Self-Report) (IDS-SR) |  | Changes from baseline to week 12. | 
| Pain Scale |  | Changes from baseline to week 12. | 
| Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) |  | Changes from baseline to week 12. | 
| Safety (Monitoring for common side effects associated with aerobic exercise and adverse events). |  | 12 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Posttraumatic Stress Disorder, PTSD, Aerobic Exercise, Women, Veteran