Restricted accessResearch articleFirst published online 2025-12
A randomized controlled trial of a lifestyle intervention on wellbeing in patients with systemic lupus erythematosus: Results from “Living well with lupus”
Patients with systemic lupus erythematosus (SLE) experience impaired wellbeing and elevated cardiovascular risk. Lifestyle interventions targeting exercise and nutrition may improve overall health outcomes, but evidence in this population remains limited.
Purpose
This study aimed to investigate the effects of a newly developed healthy lifestyle intervention, the Living Well with Lupus (LWWL) program, on overall wellbeing in patients with SLE and high cardiovascular risk.
Research Design
A 6-month, parallel-group, randomized controlled trial was conducted in São Paulo, Brazil, between August 2020 and March 2023. Participants were randomly assigned to either the LWWL intervention group or a standard care control group. The LWWL program was a goal-setting, behavioral intervention including a home-based exercise program and nutritional counseling.
Study Sample
Eighty adults with SLE and high cardiovascular risk were included. Twelve participants in the LWWL group dropped out due to personal reasons, and six in the control group did not respond to post-intervention assessments.
Data Collection and/or Analysis
Secondary outcomes related to wellbeing were assessed, including quality of life (SF-36), fatigue (FACIT), functional capacity, anxiety and depression symptoms, and sleep quality. Between-group comparisons were performed at post-intervention, and complete-case sensitivity analyses were conducted.
Results
Significant between-group differences were observed for the role physical domain of the SF-36 (EMD [95% CI]: −1.0 [−1.6; −0.4]; p = .01; ES [95% CI]: −1.03 [−1.6; −0.4]) and the FACIT fatigue score (EMD [95% CI]: 7.1 [1.6; 12.6]; p = .01; ES [95% CI]: 1.24 [0.5; 2.0]) in favor of the LWWL group. No significant between-group differences were detected for other variables (p > .05). Sensitivity analyses corroborated these findings and suggested improvements in mood and strength following the program.
Conclusions
The LWWL intervention improved fatigue and the role physical domain of quality of life in SLE patients with high cardiovascular risk. This behavioral lifestyle approach represents a potentially clinically relevant strategy to enhance selected aspects of wellbeing in SLE.
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