Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT07123220
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-14
First Post:
2025-08-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prognostic Factors for Fatigue in Patients With Systemic Lupus Erythematosus
Sponsor:
Investigación en Hemofilia y Fisioterapia
Organization:
Study Overview
Official Title:
Identification of Prognostic Factors for Fatigue in Patients With Systemic Lupus Erythematosus. A Multicenter Cross-sectional Cohort Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: