Recruiting

Exercise with PET/MRI

Sponsor:

Massachusetts General Hospital

Code:

NCT07260032

Conditions

PTSD

Cardiovascular Disease

Cardiovascular Disease Risk Factors

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Exercise

Study Details

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.

Conditions

PTSD

Cardiovascular Disease

Cardiovascular Disease Risk Factors

Study ID

NCT07260032

Start date

Feb 1, 2025

Status verified date

Nov, 2025

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Exercise

Interventions

Exercise

The exercise program will consist of specifically designed activities to place a gradually increasing workload on the cardiovascular system.

Primary outcome measure

  • Heart rate [ Time Frame: Pre-treatment; Post-treatment (12-16 weeks after pre-treatment visit) ]
  • Blood pressure [ Time Frame: Pre-treatment; Post-treatment (12-16 weeks after pre-treatment visit) ]
  • Heart rate variability [ Time Frame: Pre-treatment; Post-treatment (12-16 weeks after pre-treatment visit) ]
  • Arterial inflammation [ Time Frame: Pre-treatment; Post-treatment (12-16 weeks after pre-treatment visit) ]
  • Bone marrow inflammation [ Time Frame: Pre-treatment; Post-treatment (12-16 weeks after pre-treatment visit) ]

Central Contacts and Locations

Central contacts

Antonia Seligowski, PhD

617-643-0954aseligowski@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Antonia Seligowski, PhD

617-643-0954aseligowski@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Dec 2, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-12-02.