Sao Paulo State University
Presidente Prudente, São Paulo, 19060900, Brazil
Location status: Recruiting
NCT Number: NCT07774507
This observational study aims to investigate how 24-hour movement behaviors are associated with atherosclerotic risk in adults with rheumatoid arthritis.
These behaviors include physical activity, sedentary behavior, and sleep.
The main questions it aims to answer are:
* Are 24-hour movement behaviors, both individually and in combination, associated with indicators of atherosclerotic risk in adults with RA? * Do changes in 24-hour movement behaviors over 12 months relate to changes in indicators of atherosclerotic risk?
Participants will:
* Wear activity monitors (accelerometers) continuously for 7 days to measure physical activity, sedentary behavior, and sleep. * Answer questionnaires about their health and lifestyle. * Undergo cardiovascular assessments, body composition measurements, physical fitness tests, and blood tests to measure lipid and inflammatory profile. * Return 12 months later for follow-up assessments.
The researchers hope this study will improve understanding of how daily movement behaviors influence cardiovascular health in people with rheumatoid arthritis. The findings may help inform future recommendations to promote healthier movement behaviors and improve cardiovascular risk management in this population.
Interested in participating?
Request Info18 year–65 year
All sexes
Observational
Presidente Prudente, São Paulo, 19060900, Brazil
Location status: Recruiting
Rheumatoid arthritis (RA) is a chronic autoimmune inflammatory disease associated with a substantially increased risk of cardiovascular disease. This increased risk is only partially explained by traditional cardiovascular risk factors and is also influenced by persistent systemic inflammation, immune dysregulation, disease activity, functional impairment, and long-term pharmacological treatment. Consequently, identifying modifiable factors that contribute to cardiovascular health has become an important priority in the management of RA.
The physical activity, sedentary behavior, and sleep are recently recognized as interdependent components of the 24-hour movement behavior pattern, due to share the finite 24 hours available each day, so that spending more time in one behavior necessarily means spending less time in another. This perspective has led to analytical approaches that evaluate the composition of daily movement behaviors rather than considering each behavior separately. Although this framework has been widely investigated in the general population, longitudinal evidence in adults with rheumatoid arthritis remains limited.
This prospective cohort study was designed to investigate both cross-sectional and longitudinal associations between 24-hour movement behaviors and indicators of atherosclerotic risk over a 12-month follow-up period. Participants will undergo to evaluations at baseline and after 12 months, allowing to investigate about how the changes in movement behaviors relate to changes in vascular health over time.
Movement behaviors will be assessed objectively using triaxial accelerometers by providing objective information on physical activity, sedentary behavior, and sleep. Questionnaires will complement these measurements by capturing participants information about the health, disease and lifestyle characteristics. Cardiovascular evaluation will integrate complementary structural and functional measures of vascular health to provide a comprehensive assessment of atherosclerotic risk. Additional assessments will include blood biomarkers, body composition, physical fitness, disease-related characteristics, medication use, and traditional cardiovascular risk factors. These measures will provide a comprehensive characterization of the study population and will be considered when investigating the relationship between movement behaviors and cardiovascular health.
The analytical strategy will combine traditional multivariable regression models with compositional data analysis and time-reallocation models, that will account for the interdependent nature of physical activity, sedentary behavior, and sleep and how are associated with cardiovascular health.
This study is expected to provide one of the first prospective evaluations of the relationship between 24-hour movement behaviors and atherosclerotic risk in adults with rheumatoid arthritis. By integrating objective movement behavior assessment with comprehensive cardiovascular phenotyping, the findings may contribute to future lifestyle recommendations and strategies to improve cardiovascular risk management in this population.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline and 1-year follow up
Pulse wave velocity (m/s), measured using a cuff-based oscillometric device as an indicator of arterial stiffness.
Time frame: Baseline and 1-year follow-up
Augmentation index (%), measured using a cuff-based oscillometric device as an indicator of arterial wave reflection and arterial stiffness.
Time frame: Baseline and 1-year follow-up
Central systolic blood pressure (mmHg), estimated using a cuff-based oscillometric device as an indicator of central arterial pressure.
Time frame: Baseline and 1-year follow-up
Heart rate variability will be assessed from beat-to-beat heart rate recordings obtained under standardized resting conditions as an indicator of cardiac autonomic function. This recording will provide the standard deviation of normal-to-normal intervals (SDNN, ms), root mean square of successive differences (RMSSD, ms), low-frequency to high-frequency power ratio (LF/HF ratio), and triangular index.
Time frame: Time Frame: Baseline and 1-year follow-up
Peripheral systolic and diastolic blood pressure (mmHg) will be measured using a validated cuff-based oscillometric device.
Time frame: Baseline
Coronary artery calcium score (Agatston units) will be assessed by computed tomography as a marker of coronary atherosclerotic burden.
Time frame: Baseline
Carotid intima-media thickness (mm) will be assessed by ultrasonography as a marker of subclinical atherosclerosis.
Time frame: Baseline
The presence of carotid atherosclerotic plaque will be assessed by ultrasonography. The plaque score will be provided by accounting the number of arterial sites with presence of plaque.
Time frame: Baseline and 1-year follow-up
Blood lipid profile will include total cholesterol (mg/dL), high-density lipoprotein cholesterol (HDL-C, mg/dL), low-density lipoprotein cholesterol (LDL-C, mg/dL), and triglycerides (mg/dL) measured from fasting blood samples.
Time frame: Baseline and 1-year follow-up
High-sensitivity C-reactive protein (hs-CRP, mg/L) will be measured from fasting blood samples as a marker of systemic inflammation.
Contact information is provided by the study sponsor or research team.
William R Tebar, PhD
CONTACT
William R Tebar, PhD
CONTACT
São Paulo State University
Other
Physical Activity, Sleep and Sedentary Behavior on Atherosclerotic Risk Outcomes Among People With Rheumatoid Arthritis
Acronym: PASSARO
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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