A Pilot Exercise Study for PTSD in Women Veterans

Not Applicable

Completed

• Conditions: Posttraumatic Stress Disorder
• Interventions: Behavioral: Aerobic Exercise

• Registration Number: NCT01892033
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2013-06-28
• Study First Submitted QC: 2013-06-28
• Study First Posted: 2013-07-03
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-24
• Last Update Posted: 2019-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 31

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aerobic Exercise	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.

Primary Outcome Measures

Name	Time	Method
Clinician Administered Posttraumatic Stress Disorder Scale (CAPS)	Changes from baseline to week 12.

Secondary Outcome Measures

Name	Time	Method
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)	Changes from baseline to week 12.
PTSD Checklist	Changes from baseline to week 12.
Pain Scale	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

Trial Locations

Locations (1)

Dallas VA Medical Center; 🇺🇸 Dallas, Texas, United States