PTSDNCT07260032
Determining the Benefits of Exercise on Cardiovascular Risk in PTSD
A study testing Exercise in people with PTSD and Cardiovascular Disease, run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- PTSD, Cardiovascular Disease, Cardiovascular Disease Risk Factors
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2025to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Antonia Seligowski, PhD, 617-643-0954, aseligowski@mgh.harvard.edu
About this study
Official title: 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.
- Being tested
- Exercise
- Medical subject headings
- Stress Disorders, Post-Traumatic, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
The exercise program will consist of specifically designed activities to place a gradually increasing workload on the cardiovascular system.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Other | Not described Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
10-minute resting heart rate will be measured in beats per minute and collected from electrocardiogram (ECG)
Measured: Pre-treatment; Post-treatment (12-16 weeks after pre-treatment visit)
Blood pressure
Systolic and diastolic blood pressure
Measured: 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)
Measured: 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
Measured: 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
Measured: Pre-treatment; Post-treatment (12-16 weeks after pre-treatment visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Feb 2025
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonia V. Seligowski, PhD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07260032
- Sponsor's protocol ID
- 2024P003032
- Status last verified
- Nov 2025
- First submitted
- 4 Dec 2024
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Advanced Imaging to Determine the Benefits of Exercise on Cardiovascular Risk in PTSD
- ClinicalTrials.gov ID
- NCT07260032
- Acronym / sponsor ID
- 2024P003032
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Other | Behavioral: Exercise |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseThe exercise program will consist of specifically designed activities to place a gradually increasing workload on the cardiovascular system. | Behavioural | Exercise |
Primary outcome
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)
Blood pressure
Time frame: Pre-treatment; Post-treatment (12-16 weeks after pre-treatment visit)
Systolic and diastolic blood pressure
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)
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with PTSD and Cardiovascular Disease, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonia Seligowski, PhD (617-643-0954, aseligowski@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (time frame: Pre-treatment; Post-treatment (12-16 weeks after pre-treatment visit)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.