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NCT Number: NCT07260032

Determining 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.

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Key information

Conditions

PTSD Cardiovascular Disease Cardiovascular Disease Risk Factors Cardiovascular Diseases Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Antonia Seligowski, PhD

CONTACT

[email protected]

617-643-0954

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

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

Primary outcomes

  1. Heart rate

    Time frame: 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)

  2. Blood pressure

    Time frame: Pre-treatment; Post-treatment (12-16 weeks after pre-treatment visit)

    Systolic and diastolic blood pressure

  3. Heart rate variability

    Time frame: 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)

  4. Arterial inflammation

    Time frame: 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

  5. Bone marrow inflammation

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Antonia Seligowski, PhD

CONTACT

[email protected]

617-643-0954

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 2, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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