A Pilot Exercise Study for PTSD in Women Veterans
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|ClinicalTrials.gov Identifier: NCT01892033|
Recruitment Status : Completed
First Posted : July 3, 2013
Last Update Posted : April 26, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Posttraumatic Stress Disorder||Behavioral: Aerobic Exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Aerobic Exercise: Feasibility and Safety Assessment in Women Veterans With PTSD (AESAP)|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
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
- Clinician Administered Posttraumatic Stress Disorder Scale (CAPS) [ Time Frame: Changes from baseline to week 12. ]
- PTSD Checklist [ Time Frame: Changes from baseline to week 12. ]
- Inventory of Depressive Symptomatology (Self-Report) (IDS-SR) [ Time Frame: Changes from baseline to week 12. ]
- Pain Scale [ Time Frame: Changes from baseline to week 12. ]
- Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) [ Time Frame: Changes from baseline to week 12. ]
- Safety (Monitoring for common side effects associated with aerobic exercise and adverse events). [ Time Frame: 12 Weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01892033
|United States, Texas|
|Dallas VA Medical Center|
|Dallas, Texas, United States, 75216|
|Principal Investigator:||Geetha Shivakumar, M.D., M.S.||Dallas VA Medical Center|