Back to resultsA Pilot Exercise Study for PTSD in Women Veterans
Primary Purpose
Posttraumatic Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aerobic Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Posttraumatic Stress Disorder, PTSD, Aerobic Exercise, Women, Veteran
Eligibility Criteria
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.
Sites / Locations
- Dallas VA Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Aerobic Exercise
Arm Description
The aerobic exercise intervention is a 12-week program consisting of four 30- to 40-minute exercise sessions of brisk walking per week.
Outcomes
Primary Outcome Measures
Clinician Administered Posttraumatic Stress Disorder Scale (CAPS)
Secondary Outcome Measures
PTSD Checklist
Inventory of Depressive Symptomatology (Self-Report) (IDS-SR)
Pain Scale
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Safety (Monitoring for common side effects associated with aerobic exercise and adverse events).
Full Information
NCT ID
NCT01892033
First Posted
June 28, 2013
Last Updated
April 24, 2019
Sponsor
North Texas Veterans Healthcare System
1. Study Identification
Unique Protocol Identification Number
NCT01892033
Brief Title
A Pilot Exercise Study for PTSD in Women Veterans
Official Title
Aerobic Exercise: Feasibility and Safety Assessment in Women Veterans With PTSD (AESAP)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
North Texas Veterans Healthcare System
4. Oversight
Data Monitoring Committee
No
5. 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;
Determine the feasibility, safety, and tolerability of 12-week moderate intensity exercise
Explore potential therapeutic benefits of 12-week moderate intensity exercise. Outcome data will include posttraumatic and depressive symptoms.
Explore potential therapeutic effects of a 12-week moderate intensity exercise on comorbid pain syndrome and quality of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
Posttraumatic Stress Disorder, PTSD, Aerobic Exercise, Women, Veteran
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aerobic Exercise
Arm Type
Experimental
Arm Description
The aerobic exercise intervention is a 12-week program consisting of four 30- to 40-minute exercise sessions of brisk walking per week.
Intervention Type
Behavioral
Intervention Name(s)
Aerobic Exercise
Intervention Description
12 weeks of brisk walking
Primary Outcome Measure Information:
Title
Clinician Administered Posttraumatic Stress Disorder Scale (CAPS)
Time Frame
Changes from baseline to week 12.
Secondary Outcome Measure Information:
Title
PTSD Checklist
Time Frame
Changes from baseline to week 12.
Title
Inventory of Depressive Symptomatology (Self-Report) (IDS-SR)
Time Frame
Changes from baseline to week 12.
Title
Pain Scale
Time Frame
Changes from baseline to week 12.
Title
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Time Frame
Changes from baseline to week 12.
Title
Safety (Monitoring for common side effects associated with aerobic exercise and adverse events).
Time Frame
12 Weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geetha Shivakumar, M.D., M.S.
Organizational Affiliation
Dallas VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dallas VA Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29087845
Citation
Shivakumar G, Anderson EH, Suris 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.
Results Reference
result
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A Pilot Exercise Study for PTSD in Women Veterans
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