Clinical trial NCT01892033: 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
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: Posttraumatic Stress Disorder
PTSD
Aerobic Exercise
Women
Veteran
Lead sponsor: North Texas Veterans Healthcare System
Sponsor class: FED
First posted: 2013-07-03
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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;

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.


Eligibility 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.

Primary outcomes:
measure: Clinician Administered Posttraumatic Stress Disorder Scale (CAPS)
timeFrame: Changes from baseline to week 12.
Secondary outcomes:
measure: PTSD Checklist
timeFrame: Changes from baseline to week 12.
measure: Inventory of Depressive Symptomatology (Self-Report) (IDS-SR)
timeFrame: Changes from baseline to week 12.
measure: Pain Scale
timeFrame: Changes from baseline to week 12.
measure: Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
timeFrame: Changes from baseline to week 12.
measure: Safety (Monitoring for common side effects associated with aerobic exercise and adverse events).
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Dallas VA Medical Center
state: Texas
Study officials:
affiliation: Dallas VA Medical Center
name: Geetha Shivakumar, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References:
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.