Determining the Benefits of Exercise on Cardiovascular Risk in PTSD

Using Advanced Imaging to Determine the Benefits of Exercise on Cardiovascular Risk in PTSD

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.

Study Overview

• Status: Recruiting
• Conditions: PTSD; Cardiovascular Disease; Cardiovascular Disease Risk Factors
• Intervention / Treatment: Behavioral: Exercise

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Antonia Seligowski, PhD; Phone Number: 617-643-0954; Email: aseligowski@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Antonia Seligowski, PhD; Phone Number: 617-643-0954; Email: aseligowski@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Exercise	Behavioral: Exercise; The exercise program will consist of specifically designed activities to place a gradually increasing workload on the cardiovascular system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	10-minute resting heart rate will be measured in beats per minute and collected from electrocardiogram (ECG)	Pre-treatment; Post-treatment (12-16 weeks after pre-treatment visit)
Blood pressure	Systolic and diastolic blood pressure	Pre-treatment; Post-treatment (12-16 weeks after pre-treatment visit)
Heart rate variability	10-minute resting heart rate variability will be measured using heart rate R-peak interval times collected from electrocardiogram (ECG)	Pre-treatment; Post-treatment (12-16 weeks after pre-treatment visit)
Arterial inflammation	Aortic and carotid arterial inflammation will be based on uptake of 18F-fluorodeoxyglucose during positron emission tomography in these sites	Pre-treatment; Post-treatment (12-16 weeks after pre-treatment visit)
Bone marrow inflammation	Bone marrow inflammation will be based on uptake of 18F-fluorodeoxyglucose during positron emission tomography	Pre-treatment; Post-treatment (12-16 weeks after pre-treatment visit)

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: December 4, 2024
• First Submitted That Met QC Criteria: November 20, 2025
• First Posted (Actual): December 2, 2025

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Cardiovascular Diseases; Stress Disorders, Post-Traumatic; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: 2024P003032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No