Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-24 @ 9:28 PM
Study NCT ID:
NCT07260032
Status:
RECRUITING
Last Update Posted:
2025-12-02
First Post:
2024-12-04
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Determining the Benefits of Exercise on Cardiovascular Risk in PTSD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], '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': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2024-12-04', 'studyFirstSubmitQcDate': '2025-11-20', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart rate', 'timeFrame': 'Pre-treatment; Post-treatment (12-16 weeks after pre-treatment visit)', 'description': '10-minute resting heart rate will be measured in beats per minute and collected from electrocardiogram (ECG)'}, {'measure': 'Blood pressure', 'timeFrame': 'Pre-treatment; Post-treatment (12-16 weeks after pre-treatment visit)', 'description': 'Systolic and diastolic blood pressure'}, {'measure': 'Heart rate variability', 'timeFrame': 'Pre-treatment; Post-treatment (12-16 weeks after pre-treatment visit)', 'description': '10-minute resting heart rate variability will be measured using heart rate R-peak interval times collected from electrocardiogram (ECG)'}, {'measure': 'Arterial inflammation', 'timeFrame': 'Pre-treatment; Post-treatment (12-16 weeks after pre-treatment visit)', 'description': 'Aortic and carotid arterial inflammation will be based on uptake of 18F-fluorodeoxyglucose during positron emission tomography in these sites'}, {'measure': 'Bone marrow inflammation', 'timeFrame': 'Pre-treatment; Post-treatment (12-16 weeks after pre-treatment visit)', 'description': 'Bone marrow inflammation will be based on uptake of 18F-fluorodeoxyglucose during positron emission tomography'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['PTSD', 'Cardiovascular Disease', 'Cardiovascular Disease Risk Factors']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to use a non-invasive imaging technique called positron emission tomography/magnetic resonance imaging (PET/MRI) to investigate the effects of exercise on brain activity and arterial (blood vessel) inflammation in people with PTSD symptoms and evidence of or elevated risk for artery disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-65 years\n* Trauma exposure\n* PTSD symptoms\n* Subclinical atherosclerotic CVD (e.g., coronary, cerebrovascular, or peripheral arterial plaque or calcifications on imaging), clinical atherosclerotic CVD (e.g., myocardial infarction or revascularization), or increased risk for atherosclerotic CVD (i.e., \\>2 of hypertension, diabetes mellitus, hyperlipidemia, and active smoking)\n* Ability to understand and sign informed consent\n\nExclusion Criteria:\n\n* History of stroke, brain surgery, or seizure\n* Use of certain CVD medications (e.g., beta-blockers, high-intensity statins \\[e.g., rosuvastatin 20/40 mg and atorvastatin 40/80 mg\\], PCSK-9 inhibitors)\n* Psychiatric or cardiovascular medication change within 4 weeks (i.e., stable regimen is allowed)\n* Unstable blood pressure or cardiac arrhythmia\n* Currently in a supervised or graduated exercise program\n* Neurological or systemic inflammatory disease/current systemic anti-inflammatory therapy\n* Moderate/severe alcohol/substance use disorder\n* Current mania/psychosis\n* Weight \\>300 lbs.\n* Claustrophobia\n* Pregnancy\n* Metal implants\n* Uncontrolled hyperglycemia (HgbA1c\\>7.5%)\n* Subjects who have had significant radiation exposure as part of research (\\>2 nuclear tests, computed tomography images, or fluoroscopic procedures) during the preceding 12-months'}, 'identificationModule': {'nctId': 'NCT07260032', 'briefTitle': 'Determining the Benefits of Exercise on Cardiovascular Risk in PTSD', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Using Advanced Imaging to Determine the Benefits of Exercise on Cardiovascular Risk in PTSD', 'orgStudyIdInfo': {'id': '2024P003032'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Exercise', 'interventionNames': ['Behavioral: Exercise']}], 'interventions': [{'name': 'Exercise', 'type': 'BEHAVIORAL', 'description': 'The exercise program will consist of specifically designed activities to place a gradually increasing workload on the cardiovascular system.', 'armGroupLabels': ['Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Antonia Seligowski, PhD', 'role': 'CONTACT', 'email': 'aseligowski@mgh.harvard.edu', 'phone': '617-643-0954'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Antonia Seligowski, PhD', 'role': 'CONTACT', 'email': 'aseligowski@mgh.harvard.edu', 'phone': '617-643-0954'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Antonia V. Seligowski, PhD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}