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NCT Number: NCT07774507

Twenty-four Hour Movement Behaviors and Atherosclerotic Risk

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sao Paulo State University

Presidente Prudente, São Paulo, 19060900, Brazil

Location status: Recruiting

Location contact

William R Tebar, PhD

CONTACT

[email protected]

551832295729

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Pulse wave velocity (PWV)

    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.

  2. Augmentation index (AIx)

    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.

  3. Central systolic blood pressure (cSBP)

    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.

Secondary outcomes

  1. Heart rate variability

    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.

  2. Peripheral blood pressure

    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.

  3. Coronary artery calcium score

    Time frame: Baseline

    Coronary artery calcium score (Agatston units) will be assessed by computed tomography as a marker of coronary atherosclerotic burden.

  4. Carotid intima-media thickness (cIMT)

    Time frame: Baseline

    Carotid intima-media thickness (mm) will be assessed by ultrasonography as a marker of subclinical atherosclerosis.

  5. Carotid atherosclerotic plaque

    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.

Other outcomes

  1. Blood lipid profile

    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.

  2. High-sensitivity C-reactive protein (hs-CRP)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

William R Tebar, PhD

CONTACT

[email protected]

551832295729

William R Tebar, PhD

CONTACT

[email protected]

55183229-5729

Sponsors and collaborators

Lead sponsor

São Paulo State University

Other

Registry information

Official study title

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

Acronym: PASSARO

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Aug 19, 2026
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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