NCT07123220

Prognostic Factors for Fatigue in Patients With Systemic Lupus Erythematosus

Identification of Prognostic Factors for Fatigue in Patients With Systemic Lupus Erythematosus. A Multicenter Cross-sectional Cohort Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 884 (actual)
• Sponsor: Investigación en Hemofilia y Fisioterapia · Network
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Introduction: Fatigue is a well-established symptom in systemic lupus erythematosus. Depression and anxiety can develop at different stages of systemic lupus erythematosus and their severity can range from mild symptoms to more serious disorders. Patients with systemic lupus erythematosus may consider fatigue to be a symptom that is more severe than pain, depression, or anxiety. Objectives: To describe fatigue in patients with systemic lupus erythematosus and identify the best predictive model for fatigue in these patients. Methods: Multicenter cross-sectional cohort studies. Eighty-eight patients with systemic lupus erythematosus from different regions of Spain will be included in the studies. The primary variable will be fatigue (Fatigue Assessment Scale), with anxiety (State-Trait Anxiety Inventory) as the dependent variable. The secondary variables will be perceived quality of life (Lupus Quality of Life and 36-Item Short Form Survey Instrument), level of physical activity (International Physical Activity Questionnaire), and the main clinical, sociodemographic, and anthropometric variables. Expected results: To describe fatigue in patients with systemic lupus erythematosus, as well as the predictive model for fatigue in these patients.

Conditions

• Lupus Erythematosus, Systemic

Timeline

• Start date: 2025-09-01
• Primary completion: 2025-11-13
• Completion: 2025-12-31
• First posted: 2025-08-14
• Last updated: 2026-02-13

Locations

1 site across 1 country: Spain