Cardiovascular Risk AssessmentPASSARONCT07774507
Twenty-four Hour Movement Behaviors and Atherosclerotic Risk
An observational study of Cardiovascular Risk Assessment and Rheumatoid Arthritis (RA), run by São Paulo State University at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cardiovascular Risk Assessment, Rheumatoid Arthritis (RA), 24-Hour Movement Guidelines
- How many people
- 150 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2026to 30 Jun 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Sao Paulo State University
Presidente Prudente, São Paulo, 19060900
William R Tebar, PhD, 551832295729, w.tebar@unesp.br
About this study
Official title: 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.
Read more
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.
Read the 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.
- Keywords
- Rheumatoid Arthritis, Cardiovascular Health, Physical activity, Sleep, Sedentary behavior
- Medical subject headings
- Arthritis, Rheumatoid, Motor Activity, Sedentary Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse wave velocity (PWV)
Pulse wave velocity (m/s), measured using a cuff-based oscillometric device as an indicator of arterial stiffness.
Measured: 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.
Measured: 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.
Measured: Baseline and 1-year follow-up
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: Baseline
Carotid intima-media thickness (cIMT)
Carotid intima-media thickness (mm) will be assessed by ultrasonography as a marker of subclinical atherosclerosis.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk AssessmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- São Paulo State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Rodrigues Tebar, São Paulo State University
- Investigators
- William R Tebar, PhD, Principal investigator, São Paulo State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07774507
- Sponsor's protocol ID
- 94710225.0.0000.5402
- Acronym
- PASSARO
- Status last verified
- Aug 2026
- First submitted
- 5 Jun 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 40217417Stoner 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.
PubMed 37737729Chastin 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.
PubMed 26461112Ross 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.
PubMed 33054332Hansildaar 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.
PubMed 32904897
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity, Sleep and Sedentary Behavior on Atherosclerotic Risk Outcomes Among People With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT07774507
- Acronym / sponsor ID
- PASSARO / 94710225.0.0000.5402
- Keywords
- Rheumatoid Arthritis, Cardiovascular Health, Physical activity, Sleep, Sedentary behavior
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- São Paulo State UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
5 secondary outcomes
Heart rate variability
Time frame: Baseline and 1-year follow-up
Peripheral blood pressure
Time frame: Time Frame: Baseline and 1-year follow-up
Coronary artery calcium score
Time frame: Baseline
Carotid intima-media thickness (cIMT)
Time frame: Baseline
Carotid atherosclerotic plaque
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Background: PubMed 40217417Feehan 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.
- Background: PubMed 37737729Stoner 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.
- Background: PubMed 26461112Chastin 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.
- Background: PubMed 33054332Ross 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.
- Background: PubMed 32904897Hansildaar 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
William R Tebar, PhD principal investigator
São Paulo State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Risk Assessment and Rheumatoid Arthritis (RA), run by São Paulo State University at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact William R Tebar, PhD (551832295729, w.tebar@unesp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse wave velocity (PWV) (time frame: Baseline and 1-year follow up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07774507, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.