Prognostic Factors for Fatigue in Patients With Systemic Lupus Erythematosus

NCT07123220 | Completed

• 1 other identifier: Lup-Obs
• Study Type: observational
• Target: 884
• Locations: 1 country
• Sites: 1

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.

Conditions

Lupus Erythematosus, Systemic

Keywords

Systemic Lupus Erythematosus; Fatigue; Anxiety; Quality of life; Physical activity

Outcome Measures

Primary Outcomes (1)

• Assessment of fatigue at baseline

  Fatigue will be assessed using the Fatigue Assessment Scale. This tool provides information on the physical and psychological aspects of fatigue. This scale is highly reliable. This self-reported questionnaire consists of 10 items with a 5-point Likert response scale. Five items reflect the physical component and five reflect the psychological component. The score range of the scale is 10-50 (the higher the score, the greater the degree of fatigue).

  Baseline

Secondary Outcomes (6)

• Assessment of anxiety symptoms at baseline

  Baseline

• Assessment of quality of life at baseline

  Baseline

• Assessment of health-related quality of life at baseline

  Baseline

• Assessment of physical activity level at baseline

  Baseline

• Assessment of lupus activity index at baseline

  Baseline

Other Outcomes (5)

• Assessment of the sociodemographic variable age at baseline

  Baseline

• Assessment of the sociodemographic variable marital status at baseline

  Baseline

• Assessment of the sociodemographic variable sex at baseline

  Baseline

Study Arms (1)

Observational group

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with systemic lupus erythematosus. A total of 88 patients are expected to be included in this project.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Investigación en Hemofilia y Fisioterapia: lead

Study Sites (1)

Universidad de Oviedo

Almería, Andalusia, 33006, Spain

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Fatigue; Anxiety Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavior

Study Officials

• Rubén Cuesta-Barriuso, PhD

  Universidad de Oviedo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 14, 2025
• Study Start: September 1, 2025
• Primary Completion: November 13, 2025
• Study Completion: December 31, 2025
• Last Updated: February 13, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)