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Completed

NCT Number: NCT01892033

A Pilot Exercise Study for PTSD in Women Veterans

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.

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Key information

Conditions

Posttraumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dallas VA Medical Center

Dallas, Texas, 75216, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aerobic Exercise

Behavioral

12 weeks of brisk walking

Primary outcomes

  1. Clinician Administered Posttraumatic Stress Disorder Scale (CAPS)

    Time frame: Changes from baseline to week 12.

Secondary outcomes

  1. PTSD Checklist

    Time frame: Changes from baseline to week 12.

  2. Inventory of Depressive Symptomatology (Self-Report) (IDS-SR)

    Time frame: Changes from baseline to week 12.

  3. Pain Scale

    Time frame: Changes from baseline to week 12.

  4. Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)

    Time frame: Changes from baseline to week 12.

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

    Time frame: 12 Weeks

Sponsors and collaborators

Lead sponsor

North Texas Veterans Healthcare System

Fed

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 3, 2013
Registry last updated
Apr 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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