Determining the Benefits of Exercise on Cardiovascular Risk in PTSD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Exercise
BehavioralThe exercise program will consist of specifically designed activities to place a gradually increasing workload on the cardiovascular system.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: ExerciseOther 1 intervention
Trial outcomes
Primary outcomes
1
Heart rate
10-minute resting heart rate will be measured in beats per minute and collected from electrocardiogram (ECG)
Time frame
Pre-treatment; Post-treatment (12-16 weeks after pre-treatment visit)2
Blood pressure
Systolic and diastolic blood pressure
Time frame
Pre-treatment; Post-treatment (12-16 weeks after pre-treatment visit)3
Heart rate variability
10-minute resting heart rate variability will be measured using heart rate R-peak interval times collected from electrocardiogram (ECG)
Time frame
Pre-treatment; Post-treatment (12-16 weeks after pre-treatment visit)4
Arterial inflammation
Aortic and carotid arterial inflammation will be based on uptake of 18F-fluorodeoxyglucose during positron emission tomography in these sites
Time frame
Pre-treatment; Post-treatment (12-16 weeks after pre-treatment visit)Sponsors and contacts
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Source ClinicalTrials.gov