A Pilot Exercise Study for PTSD in Women Veterans

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01892033

Enrollment

Registered

2013-07-03

Start date

2011-08-31

Completion date

2013-09-30

Last updated

2019-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posttraumatic Stress Disorder

Keywords

Posttraumatic Stress Disorder, PTSD, Aerobic Exercise, Women, Veteran

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.

Interventions

BEHAVIORALAerobic Exercise

12 weeks of brisk walking

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Clinician Administered Posttraumatic Stress Disorder Scale (CAPS)	Changes from baseline to week 12.

Secondary

Measure	Time frame
PTSD Checklist	Changes from baseline to week 12.
Inventory of Depressive Symptomatology (Self-Report) (IDS-SR)	Changes from baseline to week 12.
Pain Scale	Changes from baseline to week 12.
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)	Changes from baseline to week 12.
Safety (Monitoring for common side effects associated with aerobic exercise and adverse events).	12 Weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026