Can a 6-Month Exercise Training Program Improve Musculoskeletal Health in Individuals with Systemic Lupus Erythematosus post Glucocorticoid Pulsetherapy? Protocol for a Randomized Controlled Trial

Abstract

ABSTRACT Background Systemic lupus erythematosus is an autoimmune condition characterized by immune dysregulation, exacerbated systemic inflammation, and tissue damage. Glucocorticoid (GC) pulse therapy is a pharmacological strategy used to manage high activity phases. Although clinically effective, it can lead to adverse effects, including compromised musculoskeletal health. Adjuvant therapies that allow maintenance of the clinical benefits of pulse therapy, while preventing or attenuating these adverse effects, are warranted. Exercise training has the potential to counteract these adverse effects, but the efficacy and viability of this approach has yet to be explored. Hence, this randomized, controlled, parallel-group trial aims to investigate the effects of a home-based, supervised, 6-month exercise training program on a battery of musculoskeletal health parameters in women with systemic lupus erythematosus who recently underwent GC pulse therapy. Methods After baseline assessments, participants will be randomized to either the control or exercise group. Participants in both groups will receive usual care, while those randomized to the exercise group will also undergo a multimodal training program. Outcomes will be examined at baseline and after 3 and 6 months. Primary outcomes include bone mineral density by dual-energy x-ray absorptiometry, bone microarchitecture by high-resolution peripheral quantitative computed tomography, and circulating levels of bone turnover markers (β-CTX and PINP). Secondary outcomes include body composition, muscle strength and function, and aerobic capacity as well as feasibility and acceptability metrics. Conclusion The information gained from this investigation has the potential to inform care and management strategies for this and similarly affected patient groups.