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

19 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

150

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: William R Tebar, PhD
  • Telefoonnummer: 551832295729
  • E-mail: w.tebar@unesp.br

Studie Contact Back-up

  • Naam: William R Tebar, PhD
  • Telefoonnummer: 55183229-5729
  • E-mail: w.tebar@unesp.br

Studie Locaties

  • Brazilië
    • São Paulo
      • Presidente Prudente, São Paulo, Brazilië, 19060900
        • Werving
        • São Paulo State University
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Pulse wave velocity (PWV)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Heart rate variability
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: Baseline
Carotid intima-media thickness (mm) will be assessed by ultrasonography as a marker of subclinical atherosclerosis.
Baseline
Carotid atherosclerotic plaque
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Blood lipid profile
Tijdsspanne: 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)
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

São Paulo State University

Onderzoekers

  • Hoofdonderzoeker: William R Tebar, PhD, São Paulo State University

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

30 juni 2027

Studie voltooiing (Geschat)

30 juni 2028

Studieregistratiedata

Eerst ingediend

5 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

17 augustus 2026

Eerst geplaatst (Werkelijk)

19 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

20 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

19 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 94710225.0.0000.5402

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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