Trial record 11 of 1006 for:    exercise AND (woman OR women OR female)

A Pilot Exercise Study for PTSD in Women Veterans

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Geetha Shivakumar, North Texas Veterans Healthcare System
ClinicalTrials.gov Identifier:
NCT01892033
First received: June 28, 2013
Last updated: September 23, 2014
Last verified: September 2014
  Purpose

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 Intervention
Posttraumatic Stress Disorder
Behavioral: Aerobic Exercise

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Aerobic Exercise: Feasibility and Safety Assessment in Women Veterans With PTSD (AESAP)

Resource links provided by NLM:


Further study details as provided by North Texas Veterans Healthcare System:

Primary Outcome Measures:
  • Clinician Administered Posttraumatic Stress Disorder Scale (CAPS) [ Time Frame: Changes from baseline to week 12. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PTSD Checklist [ Time Frame: Changes from baseline to week 12. ] [ Designated as safety issue: No ]
  • Inventory of Depressive Symptomatology (Self-Report) (IDS-SR) [ Time Frame: Changes from baseline to week 12. ] [ Designated as safety issue: No ]
  • Pain Scale [ Time Frame: Changes from baseline to week 12. ] [ Designated as safety issue: No ]
  • Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) [ Time Frame: Changes from baseline to week 12. ] [ Designated as safety issue: No ]
  • Safety (Monitoring for common side effects associated with aerobic exercise and adverse events). [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]

Enrollment: 31
Study Start Date: August 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01892033

Locations
United States, Texas
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
  More Information

No publications 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     History of Changes
Other Study ID Numbers: 10N17
Study First Received: June 28, 2013
Last Updated: September 23, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by North Texas Veterans Healthcare System:
Posttraumatic Stress Disorder
PTSD
Aerobic Exercise
Women
Veteran

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 01, 2014