Health Trialsby

Twenty-four Hour Movement Behaviors and Atherosclerotic Risk

ConditionsCardiovascular Risk Assessment Rheumatoid Arthritis (RA)24-Hour Movement Guidelines

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-65

SponsorSão Paulo State University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Pulse wave velocity (PWV)

Pulse wave velocity (m/s), measured using a cuff-based oscillometric device as an indicator of arterial stiffness.

Time frame

Baseline and 1-year follow up

2

Augmentation index (AIx)

Augmentation index (%), measured using a cuff-based oscillometric device as an indicator of arterial wave reflection and arterial stiffness.

Time frame

Baseline and 1-year follow-up

3

Central systolic blood pressure (cSBP)

Central systolic blood pressure (mmHg), estimated using a cuff-based oscillometric device as an indicator of central arterial pressure.

Time frame

Baseline and 1-year follow-up

Secondary outcomes

1

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.

Time frame

Baseline and 1-year follow-up

2

Peripheral blood pressure

Peripheral systolic and diastolic blood pressure (mmHg) will be measured using a validated cuff-based oscillometric device.

Time frame

Time Frame: Baseline and 1-year follow-up

3

Coronary artery calcium score

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

Time frame

Baseline

4

Carotid intima-media thickness (cIMT)

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

Time frame

Baseline

Other outcomes

1

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.

Time frame

Baseline and 1-year follow-up

2

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.

Time frame

Baseline and 1-year follow-up

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

São Paulo State University

Lead sponsor

Source ClinicalTrials.gov