Abstract
Objective
The aim of the present study was to investigate the effects of a lifestyle intervention on cardiometabolic risk factors in patients with systemic lupus erythematosus with a high cardiovascular risk profile.
Methods
This trial was conducted in Sao Paulo, Brazil between August 2020 and March 2023. The patients were randomly assigned to lifestyle intervention or control. The intervention was a 6-month multifaced program focused on behavioral changes through personalized recommendations for increasing physical activity (structured and non-structured) and improving eating aspects. Cardiometabolic risk score (primary outcome), anthropometry and visceral fat, aerobic capacity, blood pressure, inflammatory and oxidative stress markers, and blood flow and endothelial function were assessed before and after the intervention.
Results
A total of 80 patients were randomized. Twelve and 6 patients dropped out due to personal reasons in the intervention and control groups, respectively. Average adherence rate for the intervention was 56.9%. Intention-to-treat analysis showed no significant difference between groups in the cardiometabolic risk score (intervention group – Pre: 1.7 ± 3.6; Post: -1.6 ± 4.0; control group – Pre: -1.9 ± 3.6; Post: -2.0 ± 3.8; estimated mean difference between groups at post: -0.4; 95% confidence intervals: -2.7; 1.9; p = 0.96). This finding was confirmed by exploratory, per-protocol analysis. No significant differences were observed between adherents vs. non-adherent participants. Secondary outcomes did not change between groups.
Conclusion
This 6-month, individualized, lifestyle intervention did not improve cardiovascular risk factors in SLE patients with a high cardiovascular risk profile.
Trial Registration: clinicaltrials.gov (NCT04431167).
Key Points • This study was the first to investigate the efficacy of a multifaceted lifestyle intervention in SLE patients with a high cardiovascular risk profile. • Our lifestyle intervention did not change cardiometabolic risk score or any other cardiovascular outcomes in the population. • Whether a lifestyle intervention ameliorates other health-related outcomes and wellbeing requires further assessments. |
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Data availability
Data may be shared upon request.
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Acknowledgements and Funding
S.M.S, B.C.M., F.I.S., and B.G. were supported by São Paulo Research Foundation – FAPESP (grants #2019/15231-4, # 2019/14820-6, # 2019/14819-8 and #2017/13552-2),MR was supported by Support fund to education, research and extension at the State University of Campinas – FAEPEX accord 519.292 (98082-22) and SGP was supported by National Council for Scientific and Technological Development—CNPq (#303116/2022-6).
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SMS, BCM, FIS, and BG participated in the conception and design of the study. SMS, BCM, FIS, and MR were involved in patients’ recruitment and data collection. SP, ALSP, FRL, SU, and VRO were involved in patients’ screening and clinical assessments. SMS, BCM, FIS, MR, FBB, HR, and BG were in charge of the statistical analyses, data interpretation, and manuscript writing. SMS, BCM, FIS, and BG drafted the manuscript with critical revision from MR, SP, ALSP, FRL, SU, VRO, FBB, and HR. All authors saw and approved the final version of the manuscript for publication.
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All research protocols were approved by the local Ethical Committee (Commission for Analysis of Research Projects, CAPPesq; approval: 19554719.5.0000.0068), and informed consent was obtained from all participants. Confidentiality and privacy of the participants were rigorously maintained throughout the study, and the findings are reported with integrity and transparency.
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Sieczkowska, S.M., Mazzolani, B.C., Smaira, F.I. et al. Effects of a lifestyle intervention on cardiovascular risk factors in systemic lupus erythematosus patients: The study “Living well with lupus”. Clin Rheumatol 43, 1003–1013 (2024). https://doi.org/10.1007/s10067-024-06870-2
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DOI: https://doi.org/10.1007/s10067-024-06870-2