A Pilot Exercise Study for PTSD in Women Veterans

• Sponsor: North Texas Veterans Healthcare System (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01892033
• Collaborator: (none)
• Enrollment: 31
• Location: 1
• Arm: 1
• Duration (Months): 25
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Posttraumatic Stress Disorder	Behavioral: Aerobic Exercise	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 31 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Aerobic Exercise: Feasibility and Safety Assessment in Women Veterans With PTSD (AESAP)
• Study Start Date: Aug 1, 2011
• Actual Primary Completion Date: Sep 1, 2013
• Actual Study Completion Date: Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: Aerobic Exercise; 12 weeks of brisk walking

Outcome Measures

Primary Outcome Measures

1. Clinician Administered Posttraumatic Stress Disorder Scale (CAPS) [Changes from baseline to week 12.]

Secondary Outcome Measures

1. PTSD Checklist [Changes from baseline to week 12.]

2. Inventory of Depressive Symptomatology (Self-Report) (IDS-SR) [Changes from baseline to week 12.]

3. Pain Scale [Changes from baseline to week 12.]

4. Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) [Changes from baseline to week 12.]

5. Safety (Monitoring for common side effects associated with aerobic exercise and adverse events). [12 Weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dallas VA Medical Center	Dallas	Texas	United States	75216

Sponsors and Collaborators

• North Texas Veterans Healthcare System

Investigators

• Principal Investigator: Geetha Shivakumar, M.D., M.S., Dallas VA Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Geetha Shivakumar, Psychiatrist, Dallas VA Medical Center; Assistant Professor, UT Southwestern Medical Center, North Texas Veterans Healthcare System
• ClinicalTrials.gov Identifier: NCT01892033
• Other Study ID Numbers: 10N17
• First Posted: Jul 3, 2013
• Last Update Posted: Apr 26, 2019
• Last Verified: Apr 1, 2019

• Keywords provided by Geetha Shivakumar, Psychiatrist, Dallas VA Medical Center; Assistant Professor, UT Southwestern Medical Center, North Texas Veterans Healthcare System: Posttraumatic Stress Disorder; PTSD; Aerobic Exercise; Women; Veteran
• Additional relevant MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic

Study Results

No Results Posted as of Apr 26, 2019