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Recruiting NCT07260032

Determining the Benefits of Exercise on Cardiovascular Risk in PTSD

No phase Interventional PTSD Cardiovascular Disease Cardiovascular Disease Risk Factors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exercise.
Who it may be relevant to
Registry conditions: PTSD, Cardiovascular Disease, Cardiovascular Disease Risk Factors. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Heart rate [Time frame: Pre-treatment; Post-treatment (12-16 weeks after pre-treatment visit)]
  • Blood pressure [Time frame: Pre-treatment; Post-treatment (12-16 weeks after pre-treatment visit)]
  • Heart rate variability [Time frame: Pre-treatment; Post-treatment (12-16 weeks after pre-treatment visit)]
  • Arterial inflammation [Time frame: Pre-treatment; Post-treatment (12-16 weeks after pre-treatment visit)]
  • Bone marrow inflammation [Time frame: Pre-treatment; Post-treatment (12-16 weeks after pre-treatment visit)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Massachusetts General Hospital — Boston

Identifiers

NCT: NCT07260032 · 2024P003032

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗