- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07774507
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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: William R Tebar, PhD
- 전화번호: 551832295729
- 이메일: w.tebar@unesp.br
연구 연락처 백업
- 이름: William R Tebar, PhD
- 전화번호: 55183229-5729
- 이메일: w.tebar@unesp.br
연구 장소
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São Paulo
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Presidente Prudente, São Paulo, 브라질, 19060900
- 모병
- São Paulo State University
-
연락하다:
- William R Tebar, PhD
- 전화번호: 551832295729
- 이메일: w.tebar@unesp.br
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pulse wave velocity (PWV)
기간: Baseline and 1-year follow up
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Pulse wave velocity (m/s), measured using a cuff-based oscillometric device as an indicator of arterial stiffness.
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Baseline and 1-year follow up
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Augmentation index (AIx)
기간: Baseline and 1-year follow-up
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Augmentation index (%), measured using a cuff-based oscillometric device as an indicator of arterial wave reflection and arterial stiffness.
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Baseline and 1-year follow-up
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Central systolic blood pressure (cSBP)
기간: Baseline and 1-year follow-up
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Central systolic blood pressure (mmHg), estimated using a cuff-based oscillometric device as an indicator of central arterial pressure.
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Baseline and 1-year follow-up
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Heart rate variability
기간: 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.
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Baseline and 1-year follow-up
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Peripheral blood pressure
기간: Time Frame: Baseline and 1-year follow-up
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Peripheral systolic and diastolic blood pressure (mmHg) will be measured using a validated cuff-based oscillometric device.
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Time Frame: Baseline and 1-year follow-up
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Coronary artery calcium score
기간: Baseline
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Coronary artery calcium score (Agatston units) will be assessed by computed tomography as a marker of coronary atherosclerotic burden.
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Baseline
|
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Carotid intima-media thickness (cIMT)
기간: Baseline
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Carotid intima-media thickness (mm) will be assessed by ultrasonography as a marker of subclinical atherosclerosis.
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Baseline
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Carotid atherosclerotic plaque
기간: 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
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Blood lipid profile
기간: Baseline and 1-year follow-up
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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.
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Baseline and 1-year follow-up
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High-sensitivity C-reactive protein (hs-CRP)
기간: Baseline and 1-year follow-up
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High-sensitivity C-reactive protein (hs-CRP, mg/L) will be measured from fasting blood samples as a marker of systemic inflammation.
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Baseline and 1-year follow-up
|
공동 작업자 및 조사자
수사관
- 수석 연구원: William R Tebar, PhD, São Paulo State University
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 94710225.0.0000.5402
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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