NCT01892033

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. 1.Determine the feasibility, safety, and tolerability of 12-week moderate intensity exercise
  2. 2.Explore potential therapeutic benefits of 12-week moderate intensity exercise. Outcome data will include posttraumatic and depressive symptoms.
  3. 3.Explore potential therapeutic effects of a 12-week moderate intensity exercise on comorbid pain syndrome and quality of life.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 3, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

April 26, 2019

Status Verified

April 1, 2019

Enrollment Period

2.1 years

First QC Date

June 28, 2013

Last Update Submit

April 24, 2019

Conditions

Posttraumatic Stress Disorder

Keywords

Posttraumatic Stress DisorderPTSDAerobic ExerciseWomenVeteran

Outcome Measures

Primary Outcomes (1)

  • Clinician Administered Posttraumatic Stress Disorder Scale (CAPS)

    Changes from baseline to week 12.

Secondary Outcomes (5)

  • 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

Study Arms (1)

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.

Behavioral: Aerobic Exercise

Interventions

Aerobic ExerciseBEHAVIORAL

12 weeks of brisk walking

Aerobic Exercise

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dallas VA Medical Center

Dallas, Texas, 75216, United States

Location

Related Publications (1)

  • 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.

    PMID: 29087845RESULT

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Exercise

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Geetha Shivakumar, M.D., M.S.

    Dallas VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Psychiatrist, Dallas VA Medical Center; Assistant Professor, UT Southwestern Medical Center

Study Record Dates

First Submitted

June 28, 2013

First Posted

July 3, 2013

Study Start

August 1, 2011

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

April 26, 2019

Record last verified: 2019-04

Locations

US(1)