Exercise to lower heart and artery risk in people with PTSD
Using Advanced Imaging to Determine the Benefits of Exercise on Cardiovascular Risk in PTSD
This project will test whether a supervised exercise program can change brain activity and reduce artery inflammation in adults with PTSD who have or are at risk for atherosclerotic cardiovascular disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT07260032 on ClinicalTrials.gov |
What this trial studies
Adults aged 18–65 with trauma exposure and PTSD symptoms who also have evidence of or elevated risk for atherosclerotic cardiovascular disease will be enrolled. Participants will complete a supervised exercise intervention while undergoing non-invasive PET/MRI imaging to measure brain activity and arterial inflammation. Imaging and clinical measures will be obtained before and after the intervention to document any changes. The protocol excludes people with certain neurological conditions, unstable cardiac issues, or specific cardiovascular medications that could confound imaging or exercise safety.
Who should consider this trial
Good fit: Adults 18–65 with trauma exposure and PTSD symptoms who have subclinical or clinical atherosclerotic disease or at least two major cardiovascular risk factors and who can give informed consent are ideal candidates.
Not a fit: People without PTSD symptoms or without evidence of or risk for atherosclerotic cardiovascular disease are unlikely to benefit from the findings of this intervention.
Why it matters
Potential benefit: If successful, this approach could show that regular exercise reduces brain-related and artery inflammation and thereby helps lower cardiovascular risk in people with PTSD.
How similar studies have performed: Prior research supports that exercise can improve systemic inflammation and cardiovascular risk factors and can help PTSD symptoms, but using PET/MRI to link brain activity with arterial inflammation in PTSD is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Antonia Seligowski, PhD
- Email: aseligowski@mgh.harvard.edu
- Phone: 617-643-0954
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.