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Twenty-four Hour Movement Behaviors and Atherosclerotic Risk (PASSARO)

19 de agosto de 2026 actualizado por: William Rodrigues Tebar, São Paulo State University

Physical Activity, Sleep and Sedentary Behavior on Atherosclerotic Risk Outcomes Among People With Rheumatoid Arthritis

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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Estimado)

150

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: William R Tebar, PhD
  • Número de teléfono: 551832295729
  • Correo electrónico: w.tebar@unesp.br

Copia de seguridad de contactos de estudio

  • Nombre: William R Tebar, PhD
  • Número de teléfono: 55183229-5729
  • Correo electrónico: w.tebar@unesp.br

Ubicaciones de estudio

    • São Paulo
      • Presidente Prudente, São Paulo, Brasil, 19060900
        • Reclutamiento
        • São Paulo State University
        • Contacto:
          • William R Tebar, PhD
          • Número de teléfono: 551832295729
          • Correo electrónico: w.tebar@unesp.br

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

The study population will consist of adults with a medical diagnosis of rheumatoid arthritis. Participants will be recruited through rheumatology clinics, healthcare services, hospitals, rehabilitation centers, patient support groups, and community outreach initiatives. The recruitment strategy is intended to include individuals with diverse socioeconomic backgrounds, disease durations, and levels of disease severity, thereby enhancing the representativeness of the study population.

Descripción

Inclusion Criteria:

  • Medical diagnosis of rheumatoid arthritis.
  • Age between 18 and 65 years.
  • Provide written informed consent.
  • Independence in daily living activities defined as a Katz Index score of 5 or 6 points.

Exclusion Criteria:

  • Acute infectious disease at the time of assessment.
  • Pregnancy or breastfeeding.
  • Cognitive impairment identified by the Mini-Mental State Examination according to established cutoff values.
  • History of cardiovascular disease, including coronary artery disease, cerebrovascular disease, peripheral arterial disease, rheumatic heart disease, congenital heart disease, deep vein thrombosis, or pulmonary embolism.
  • Use of uncontrolled vasoactive medication.
  • Inability to comply with accelerometer wear requirements.
  • Inability to complete study questionnaires or physical assessments.
  • Invalid accelerometer data according to the study wear-time criteria.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Pulse wave velocity (PWV)
Periodo de tiempo: Baseline and 1-year follow up
Pulse wave velocity (m/s), measured using a cuff-based oscillometric device as an indicator of arterial stiffness.
Baseline and 1-year follow up
Augmentation index (AIx)
Periodo de tiempo: 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.
Baseline and 1-year follow-up
Central systolic blood pressure (cSBP)
Periodo de tiempo: 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.
Baseline and 1-year follow-up

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Heart rate variability
Periodo de tiempo: 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.
Baseline and 1-year follow-up
Peripheral blood pressure
Periodo de tiempo: 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 and 1-year follow-up
Coronary artery calcium score
Periodo de tiempo: Baseline
Coronary artery calcium score (Agatston units) will be assessed by computed tomography as a marker of coronary atherosclerotic burden.
Baseline
Carotid intima-media thickness (cIMT)
Periodo de tiempo: Baseline
Carotid intima-media thickness (mm) will be assessed by ultrasonography as a marker of subclinical atherosclerosis.
Baseline
Carotid atherosclerotic plaque
Periodo de tiempo: 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.
Baseline

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Blood lipid profile
Periodo de tiempo: 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.
Baseline and 1-year follow-up
High-sensitivity C-reactive protein (hs-CRP)
Periodo de tiempo: 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.
Baseline and 1-year follow-up

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: William R Tebar, PhD, São Paulo State University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de septiembre de 2026

Finalización primaria (Estimado)

30 de junio de 2027

Finalización del estudio (Estimado)

30 de junio de 2028

Fechas de registro del estudio

Enviado por primera vez

5 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

17 de agosto de 2026

Publicado por primera vez (Actual)

19 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

20 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

19 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Individual participant data (IPD) will not be shared due to privacy and confidentiality considerations. Study findings will be reported in aggregate form through scientific publications and presentations.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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