Cardiovascular Disease, Cardiovascular Disease Risk Factors, PTSD
Conditions
Brief summary
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.
Interventions
BEHAVIORALExercise
The exercise program will consist of specifically designed activities to place a gradually increasing workload on the cardiovascular system.
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-65 years * Trauma exposure * PTSD symptoms * 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) * Ability to understand and sign informed consent
Exclusion criteria
* History of stroke, brain surgery, or seizure * 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) * Psychiatric or cardiovascular medication change within 4 weeks (i.e., stable regimen is allowed) * Unstable blood pressure or cardiac arrhythmia * Currently in a supervised or graduated exercise program * Neurological or systemic inflammatory disease/current systemic anti-inflammatory therapy * Moderate/severe alcohol/substance use disorder * Current mania/psychosis * Weight \>300 lbs. * Claustrophobia * Pregnancy * Metal implants * Uncontrolled hyperglycemia (HgbA1c\>7.5%) * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate | Pre-treatment; Post-treatment (12-16 weeks after pre-treatment visit) | 10-minute resting heart rate will be measured in beats per minute and collected from electrocardiogram (ECG) |
| Blood pressure | Pre-treatment; Post-treatment (12-16 weeks after pre-treatment visit) | Systolic and diastolic blood pressure |
| Heart rate variability | Pre-treatment; Post-treatment (12-16 weeks after pre-treatment visit) | 10-minute resting heart rate variability will be measured using heart rate R-peak interval times collected from electrocardiogram (ECG) |
| Arterial inflammation | Pre-treatment; Post-treatment (12-16 weeks after pre-treatment visit) | Aortic and carotid arterial inflammation will be based on uptake of 18F-fluorodeoxyglucose during positron emission tomography in these sites |
| Bone marrow inflammation | Pre-treatment; Post-treatment (12-16 weeks after pre-treatment visit) | Bone marrow inflammation will be based on uptake of 18F-fluorodeoxyglucose during positron emission tomography |
Countries
United States
Contacts
Primary ContactAntonia Seligowski, PhD
Outcome results
None listed