Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2026-03-10 @ 6:18 PM
Study NCT ID:
NCT01892033
Status:
COMPLETED
Last Update Posted:
2019-04-26
First Post:
2013-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Exercise Study for PTSD in Women Veterans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-24', 'studyFirstSubmitDate': '2013-06-28', 'studyFirstSubmitQcDate': '2013-06-28', 'lastUpdatePostDateStruct': {'date': '2019-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinician Administered Posttraumatic Stress Disorder Scale (CAPS)', 'timeFrame': 'Changes from baseline to week 12.'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Posttraumatic Stress Disorder', 'PTSD', 'Aerobic Exercise', 'Women', 'Veteran'], 'conditions': ['Posttraumatic Stress Disorder']}, 'referencesModule': {'references': [{'pmid': '29087845', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nSpecific aims of the study are to;\n\n1. Determine the feasibility, safety, and tolerability of 12-week moderate intensity exercise\n2. Explore potential therapeutic benefits of 12-week moderate intensity exercise. Outcome data will include posttraumatic and depressive symptoms.\n3. Explore potential therapeutic effects of a 12-week moderate intensity exercise on comorbid pain syndrome and quality of life.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Women veterans ages 18 and older\n2. Premenopausal women of childbearing potential with a negative pregnancy test\n3. 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\n4. Relatively low sedentary life style\n5. Existing psychotropic medications are allowed if on a stable dose\n6. 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.\n\nExclusion Criteria:\n\n1. 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.\n2. Serious psychopathology\n3. Actively suicidal or homicidal\n4. Psychiatric hospitalization within the past 30 days\n5. Active medical conditions that preclude the use of aerobic exercise such as uncontrolled hypertension, active musculoskeletal degenerative conditions, and symptomatic cardiovascular or respiratory conditions.'}, 'identificationModule': {'nctId': 'NCT01892033', 'briefTitle': 'A Pilot Exercise Study for PTSD in Women Veterans', 'organization': {'class': 'FED', 'fullName': 'North Texas Veterans Healthcare System'}, 'officialTitle': 'Aerobic Exercise: Feasibility and Safety Assessment in Women Veterans With PTSD (AESAP)', 'orgStudyIdInfo': {'id': '10N17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aerobic Exercise', 'description': 'The aerobic exercise intervention is a 12-week program consisting of four 30- to 40-minute exercise sessions of brisk walking per week.', 'interventionNames': ['Behavioral: Aerobic Exercise']}], 'interventions': [{'name': 'Aerobic Exercise', 'type': 'BEHAVIORAL', 'description': '12 weeks of brisk walking', 'armGroupLabels': ['Aerobic Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75216', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Dallas VA Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Geetha Shivakumar, M.D., M.S.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dallas VA Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'North Texas Veterans Healthcare System', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Psychiatrist, Dallas VA Medical Center; Assistant Professor, UT Southwestern Medical Center', 'investigatorFullName': 'Geetha Shivakumar', 'investigatorAffiliation': 'North Texas Veterans Healthcare System'}}}}