Status:
COMPLETED
Lifestyle and Cardiometabolic Risk in Post-9/11 Veterans
Lead Sponsor:
VA Office of Research and Development
Conditions:
PTSD
Cardiovascular Disease
Eligibility:
All Genders
18-75 years
Brief Summary
Heart disease and diabetes are leading causes of death and disability in the US, especially among Veterans. Posttraumatic stress disorder (PTSD) is a disabling condition that also affects many Veteran...
Detailed Description
Cardiometabolic disease (e.g., type 2 diabetes or cardiovascular disease) is a leading cause of disability and mortality in the United States, and especially so among Veterans. Posttraumatic stress di...
Eligibility Criteria
Inclusion
- individuals must be age 18-75
- a military veteran or active military service member who has deployed or is scheduled to deploy in support of post-9/11 operations, such as:
- Operation Iraqi Freedom
- Operations Enduring Freedom
- Operation New Dawn
- there are no additional inclusion criteria for Aims 1 and 2
- however, for the Supplemental Aim, to be eligible to participate all interested veterans must have a diagnosis of PTSD (i.e., current or lifetime)
Exclusion
- individuals will be excluded for a history of neurological illness or cognitive disorders other than TBI (e.g., Huntington's, Parkinson's, dementia, or Multiple Sclerosis), and non-TBI related seizures
- additionally, individuals are excluded for a current diagnosis of psychotic disorders, schizophrenia, bipolar disorders, current suicidal or homicidal ideation/intention/planning
- there are no additional exclusionary criteria for Aims 1 and 2
- however, for the Supplemental Aim, any participants with an absolute or relative contraindication to exercise testing as recommended by the American Thoracic Society and the American College of Chest Physicians (e.g., acute myocardial infarction, unstable angina, respiratory failure, uncontrolled asthma, orthopedic impairments that compromise exercise performance, uncontrolled heart failure and acute hypertension) will be excluded from the cardiorespiratory exercise test
Key Trial Info
Start Date :
February 28 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 9 2025
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT04911153
Start Date
February 28 2022
End Date
June 9 2025
Last Update
June 18 2025
Active Locations (1)
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1
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130-4817