Background: Continuous aerobic exercise at moderate to high intensity for people with systemic lupus erythematosus (SLE) indicate positive effects regarding aerobic capacity, fatigue, and depressive symptoms. However, the effects of aerobic high-intensity interval training (HIIT) have not been investigated in SLE. Objectives: The overall aim was to investigate whether aerobic capacity, disease activity and patient-reported outcomes can improve with aerobic HIIT combined with resistance training in patients with SLE. Methods: We designed a multicenter randomized controlled trial where patients, from three Swedish tertiary referral centers, fulfilling the EULAR/ACR criteria for SLE, are randomized to aerobic HIIT combined with resistance training in addition to usual care or to a control group receiving usual care for 6 months. Maximal aerobic capacity (VO₂ max), maximal capacity (Max Watt) and blood pressure are measured during a bicycle ergometer exercise test. Blood samples are collected, and disease activity and organ damage are assessed by a physician. In addition, questionnaires regarding disease activity, fatigue, depression, and health-related quality of life (HRQL) are completed. Measurements are performed at baseline, at 3 months, and at 6 months. Patients who are randomized to the intervention group perform supervised aerobic HIIT combined with resistance training 2 times/week and unsupervised training 1 time/week for 3 months. Between 3 and 6 months the patients are training by themselves with support by a physiotherapist, once a week, via a videocall or telephone calls. We have hitherto recruited 19 patients from one of the three centers. For this interim analysis, we analyzed data from 16 patients who completed the study (Table 1). Results: We herein present interim results from the first 3 months at one center, showing that in the intervention group, VO₂ max (mL/min: p=0.008 and mL/kg/min: p=0.007) and Max watt (p=0.01) increased and resting blood pressure (p=0.02/p=0.03) decreased, while no significant changes were detected in the control group. Changes in VO₂ max (mL/min: p=0.001 and mL/kg/min: p=0.002) and Max watt (p=0.008) were significant between the two groups, in favor of the intervention group. Self-assessed disease activity (SLAQ-NRS) decreased (p=0.016) in the intervention group, while there was no significant change in the control group and no significant difference between the groups. SLEDAI-2K did not change significantly in the groups and no adverse events were reported. Further, the intervention group showed improvements in the Physical Functioning (p=0.016), Role Physical (p=0.041), Bodily Pain (p=0.024), Vitality (p=0.017), Social Functioning (p=0.041), and Mental Health (p=0.041) domains of the 36-item Short Form survey. No significant changes were seen in the control group. Changes in Role Physical and Bodily Pain scores were significantly different (p=0.012, p=0.023) between the two groups, in favor of the intervention group. Conclusion: Interim results indicate that aerobic HIIT combined with resistance training is safe and has positive effects concerning aerobic- and physical capacity as well as several aspects of HRQL in patients with SLE. REFERENCES: NIL. Registered on ClinicalTrials.gov public website Acknowledgements: This study is funded by the Swedish Rheumatism Association. The authors thank all participating patients, the biomedical technicians Safia Saad and Lisa Wang, and the rheumatologists Annika Söderberg, Cathrine Espmarker and Theodoros Lappas at the Örebro University hospital. We also thank the operational manager and cardiologist Stella Cizinsky and operational manager and physiotherapist Anette Forsberg at the Örebro University Hospital for supporting the study. Disclosure of Interests: Carina Boström: None declared, Katrina Dahlin: None declared, Romeissa Nilsson-Khelili: None declared, Linnea Näsman: None declared, Devrim Can SARAÇ: None declared, Yvonne Enman: None declared, George S Metsios: None declared, Sara Magnusson Bucher: None declared, Ioannis Parodis Received research funding and/or honoraria from Amgen, AstraZeneca, Aurinia, Elli Lilly, Gilead, GlaxoSmithKline, Janssen, Novartis, Otsuka, and Roche.
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