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

North Texas Veterans Healthcare System1 site in 1 country31 target enrollmentAugust 2011

ConditionsPosttraumatic Stress Disorder

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Posttraumatic Stress Disorder
Sponsor: North Texas Veterans Healthcare System
Enrollment: 31
Locations: 1
Primary Endpoint: Clinician Administered Posttraumatic Stress Disorder Scale (CAPS)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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;

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.

Registry

clinicaltrials.gov

Start Date

August 2011

End Date

September 2013

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

North Texas Veterans Healthcare System

Responsible Party

Principal Investigator

Geetha Shivakumar

Psychiatrist, Dallas VA Medical Center; Assistant Professor, UT Southwestern Medical Center

North Texas Veterans Healthcare System

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Clinician Administered Posttraumatic Stress Disorder Scale (CAPS)

Time Frame: Changes from baseline to week 12.

Secondary Outcomes

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