This trial is active, not recruiting.

Condition posttraumatic stress disorder
Treatment aerobic exercise
Sponsor North Texas Veterans Healthcare System
Start date August 2011
End date October 2013
Trial size 35 participants
Trial identifier NCT01892033, 10N17


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
The aerobic exercise intervention is a 12-week program consisting of four 30- to 40-minute exercise sessions of brisk walking per week.
aerobic exercise

Primary Outcomes

Clinician Administered Posttraumatic Stress Disorder Scale (CAPS)
time frame: Changes from baseline to week 12.

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

Eligibility Criteria

Female participants from 18 years up to 50 years old.

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.

Additional Information

Official title Aerobic Exercise: Feasibility and Safety Assessment in Women Veterans With PTSD (AESAP)
Principal investigator Geetha Shivakumar, M.D., M.S.
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by North Texas Veterans Healthcare System.