Determining the Benefits of Exercise on Cardiovascular Risk in PTSD

NCT ID: NCT07260032

Last Updated: 2025-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2027-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

PTSD Cardiovascular Disease Cardiovascular Disease Risk Factors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Exercise

Group Type OTHER

Exercise

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Exercise

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Antonia V. Seligowski, PhD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Antonia Seligowski, PhD

Role: CONTACT

617-643-0954

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Antonia Seligowski, PhD

Role: primary

617-643-0954

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2024P003032

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Non Invasive Brain Stimulation for PTSD
NCT02442843 COMPLETED EARLY_PHASE1
Cognitive Training for PTSD
NCT03316196 COMPLETED NA
Exercise and PTSD in Older Veterans
NCT02295995 COMPLETED NA
Brief Exposure and Exercise for PTSD.
NCT07080606 RECRUITING NA
CPT-fMRI Study for PTSD
NCT03229915 COMPLETED NA