Determining the Benefits of Exercise on Cardiovascular Risk in PTSD

NCT07260032 | Recruiting

• 1 other identifier: 2024P003032
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• 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)

Study Arms (1)

Exercise

OTHER

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

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

Exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Cardiovascular Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Antonia Seligowski, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 2, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)