Prognostic Factors for Fatigue in Patients With Systemic Lupus Erythematosus

Investigación en Hemofilia y Fisioterapia

Status: Not yet enrolling

Conditions: Lupus Erythematosus, Systemic

Study type: Observational

Funder types: NETWORK

Identifiers

NCT07123220

Lup-Obs

Details and patient eligibility

About

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.

Enrollment: 88 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed with systemic lupus erythematosus.
• Over 18 years of age.
• Who have not had any flare-ups in the last 6 months.
• Who sign the informed consent form.

Exclusion criteria

• Patients with neurological or cognitive impairments that prevent them from understanding the questionnaires and physical tests.
• Patients who are receiving an intervention (physiotherapy or orthopedic) at the time of the study.

Trial design

88 participants in 1 patient group

Observational group

Description:

Patients who meet the selection criteria will be informed of the characteristics, objectives, and risks of the evaluation. They will be provided with patient information and informed consent documents. After confirming that they do not meet any of the exclusion criteria, the dependent and confounding variables of the study will be evaluated. The assessment will be carried out using self-questionnaires that will be sent online to the various associations of patients with systemic lupus erythematosus that are part of the Spanish Lupus Federation. All questionnaire assessments will be carried out by the same physical therapist, following the same assessment protocol.