Determining the Benefits of Exercise on Cardiovascular Risk in PTSD

Mass General Brigham

Status: Enrolling

Conditions: PTSD; Cardiovascular Disease Risk Factors; Cardiovascular Disease

Treatments: Behavioral: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT07260032

2024P003032

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Exercise

Other group

Treatment:

Behavioral: Exercise