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

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.

Study Overview

• Status: Recruiting
• Conditions: Rheumatoid Arthritis (RA); Cardiovascular Risk Assessment; 24-Hour Movement Guidelines

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: William R Tebar, PhD; Phone Number: 551832295729; Email: w.tebar@unesp.br
• Study Contact Backup: Name: William R Tebar, PhD; Phone Number: 55183229-5729; Email: w.tebar@unesp.br

Study Locations

• Brazil
  • São Paulo
    • Presidente Prudente, São Paulo, Brazil, 19060900
      • Recruiting
      • São Paulo State University
      • Contact: William R Tebar, PhD; Phone Number: 551832295729; Email: w.tebar@unesp.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulse wave velocity (PWV)	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)	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)	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate variability	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	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	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)	Carotid intima-media thickness (mm) will be assessed by ultrasonography as a marker of subclinical atherosclerosis.	Baseline
Carotid atherosclerotic plaque	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood lipid profile	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)	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

Collaborators and Investigators

• Sponsor: São Paulo State University
• Investigators: Principal Investigator: William R Tebar, PhD, São Paulo State University

Publications and helpful links

General Publications

• Ross R, Chaput JP, Giangregorio LM, Janssen I, Saunders TJ, Kho ME, Poitras VJ, Tomasone JR, El-Kotob R, McLaughlin EC, Duggan M, Carrier J, Carson V, Chastin SF, Latimer-Cheung AE, Chulak-Bozzer T, Faulkner G, Flood SM, Gazendam MK, Healy GN, Katzmarzyk PT, Kennedy W, Lane KN, Lorbergs A, Maclaren K, Marr S, Powell KE, Rhodes RE, Ross-White A, Welsh F, Willumsen J, Tremblay MS. Canadian 24-Hour Movement Guidelines for Adults aged 18-64 years and Adults aged 65 years or older: an integration of physical activity, sedentary behaviour, and sleep. Appl Physiol Nutr Metab. 2020 Oct;45(10 (Suppl. 2)):S57-S102. doi: 10.1139/apnm-2020-0467.
• Chastin SF, Palarea-Albaladejo J, Dontje ML, Skelton DA. Combined Effects of Time Spent in Physical Activity, Sedentary Behaviors and Sleep on Obesity and Cardio-Metabolic Health Markers: A Novel Compositional Data Analysis Approach. PLoS One. 2015 Oct 13;10(10):e0139984. doi: 10.1371/journal.pone.0139984. eCollection 2015.
• Hansildaar R, Vedder D, Baniaamam M, Tausche AK, Gerritsen M, Nurmohamed MT. Cardiovascular risk in inflammatory arthritis: rheumatoid arthritis and gout. Lancet Rheumatol. 2021 Jan;3(1):e58-e70. doi: 10.1016/S2665-9913(20)30221-6. Epub 2020 Sep 1.
• Feehan L, Xie H, Lu N, Li LC. Twenty-four hour physical activity, sedentary behaviour and sleep profiles in adults living with rheumatoid arthritis: a cross-sectional latent class analysis. J Act Sedentary Sleep Behav. 2024 Apr 17;3(1):10. doi: 10.1186/s44167-024-00049-5.
• Stoner L, Higgins S, Paterson C. The 24-h activity cycle and cardiovascular outcomes: establishing biological plausibility using arterial stiffness as an intermediate outcome. Am J Physiol Heart Circ Physiol. 2023 Dec 1;325(6):H1243-H1263. doi: 10.1152/ajpheart.00258.2023. Epub 2023 Sep 22.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: June 5, 2026
• First Submitted That Met QC Criteria: August 17, 2026
• First Posted (Actual): August 19, 2026

Study Record Updates

• Last Update Posted (Actual): August 20, 2026
• Last Update Submitted That Met QC Criteria: August 19, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Sleep; Physical activity; Rheumatoid Arthritis; Cardiovascular Health; Sedentary behavior
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Behavior; Skin and Connective Tissue Diseases; Arthritis, Rheumatoid; Motor Activity; Sedentary Behavior
• Other Study ID Numbers: 94710225.0.0000.5402

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No