A Pilot Exercise Study for PTSD in Women Veterans

Posttraumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01892033
• Other study ID #: 10N17
• Status: Completed
• Phase: N/A
• Start date: August 2011
• Est. completion date: September 2013

Study information

• Verified date: April 2019
• Source: North Texas Veterans Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Aerobic Exercise
12 weeks of brisk walking

Locations

Country	Name	City	State
United States	Dallas VA Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
North Texas Veterans Healthcare System

Country where clinical trial is conducted

United States, 

References & Publications (1)

Shivakumar G, Anderson EH, Surís AM, North CS. Exercise for PTSD in Women Veterans: A Proof-of-Concept Study. Mil Med. 2017 Nov;182(11):e1809-e1814. doi: 10.7205/MILMED-D-16-00440. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician Administered Posttraumatic Stress Disorder Scale (CAPS)		Changes from baseline to week 12.
Secondary	PTSD Checklist		Changes from baseline to week 12.
Secondary	Inventory of Depressive Symptomatology (Self-Report) (IDS-SR)		Changes from baseline to week 12.
Secondary	Pain Scale		Changes from baseline to week 12.
Secondary	Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)		Changes from baseline to week 12.
Secondary	Safety (Monitoring for common side effects associated with aerobic exercise and adverse events).		12 Weeks