A Pilot Exercise Study for PTSD in Women Veterans

April 24, 2019 updated by: Geetha Shivakumar, North Texas Veterans Healthcare System

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75216
        • Dallas VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinician Administered Posttraumatic Stress Disorder Scale (CAPS)
Time Frame: Changes from baseline to week 12.
Changes from baseline to week 12.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

North Texas Veterans Healthcare System

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (ACTUAL)

September 1, 2013

Study Completion (ACTUAL)

September 1, 2013

Study Registration Dates

First Submitted

June 28, 2013

First Submitted That Met QC Criteria

June 28, 2013

First Posted (ESTIMATE)

July 3, 2013

Study Record Updates

Last Update Posted (ACTUAL)

April 26, 2019

Last Update Submitted That Met QC Criteria

April 24, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10N17

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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