NCT01892033CompletedNot Applicable
Aerobic Exercise: Feasibility and Safety Assessment in Women Veterans With PTSD (AESAP)
North Texas Veterans Healthcare System2 sites in 1 country31 target enrollmentStarted: August 1, 2011Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 31
- Locations
- 2
- Primary Endpoint
- Clinician Administered Posttraumatic Stress Disorder Scale (CAPS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Aerobic Exercise
Experimental
The aerobic exercise intervention is a 12-week program consisting of four 30- to 40-minute exercise sessions of brisk walking per week.
Intervention: Aerobic Exercise (Behavioral)
Outcomes
Primary Outcomes
Clinician Administered Posttraumatic Stress Disorder Scale (CAPS)
Time Frame: Changes from baseline to week 12.
Secondary Outcomes
- Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)(Changes from baseline to week 12.)
- Pain Scale(Changes from baseline to week 12.)
- PTSD Checklist(Changes from baseline to week 12.)
- Inventory of Depressive Symptomatology (Self-Report) (IDS-SR)(Changes from baseline to week 12.)
- Safety (Monitoring for common side effects associated with aerobic exercise and adverse events).(12 Weeks)
Investigators
Geetha Shivakumar
Psychiatrist, Dallas VA Medical Center; Assistant Professor, UT Southwestern Medical Center
North Texas Veterans Healthcare System
Study Sites (2)
Loading locations...
Similar Trials
Terminated
Not Applicable
Combined Modality Exercise and Appetite in Breast Cancer SurvivorsBreast Cancer FemaleOverweight and ObesityNCT04576247University of Colorado, Denver3
Completed
Not Applicable
Exercise and Nutrition Interventions During ChemotherapyPeripheral NeuropathyNCT03021174University of Rochester21
Terminated
Not Applicable
Exercise Program During Chemotherapy in Metastatic Colorectal CancerStage IV Colorectal CancerNCT03111823University of Southern California2
Completed
Not Applicable
Exercise Program for Adolescents and Young Adults With CancerLymphomaLeukemiaNCT00502749M.D. Anderson Cancer Center37
Completed
Not Applicable
Moderate Intensity Training in Patients With Truncating Genetic Variants in TTN.CardiomyopathiesTruncation MutationTTNNCT05180188Rigshospitalet, Denmark14