Physical Activity in Patients With Systemic Lupus Erythematosus

NCT ID: NCT06919250

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 63 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2025-05-20

Brief Summary

Background. Systemic lupus erythematosus is a chronic autoimmune disease. Among its main clinical manifestations are musculoskeletal symptoms such as myopathies, arthritis, arthralgias or osteonecrosis. Physical activity can improve the perception of quality of life and well-being of these patients.

Objective. To assess the degree of physical activity in patients with systemic lupus erythematosus, and to identify the main clinical, sociodemographic and anthropometric variables that influence it.

Method. Ambispective cohort study. Sixty-three patients with systemic lupus erythematosus will be recruited. The primary variable will be the degree of physical activity (International Physical Activity Questionnaire). Secondary and modifying variables will be: fatigue (Fatigue Assessment Scale), health-related quality of life (Short Form-36 Health Survey), sleep disorders (Pittsburgh Sleep Quality Index), depressive (Beck Depression Inventory -II) and anxiety symptoms (Hamilton Anxiety Rating Scale), age, and disease activity, duration and damage. Possible confounding variables will be sex, toxic habits (smoking), diagnosis of other pathologies and exposure to therapy. In the analysis, the degree of physical activity of patients with lupus erythematosus will be calculated and a multiple regression analysis will be performed to evaluate the predictive model that best fits the degree of activity of these patients.

Expectedresults. To identify the degree of physical activity of patients with systemic lupus erythematosus and to identify the predictive model of physical activity in these patients.

Conditions

Lupus Erythematosus, Systemic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Patients with systemic lupus erythematosus

Patients with systemic lupus erythematosus who will participate through an interview format with closed questions where no data will be collected that would allow identification of the subjects.

Patients with systemic lupus erythematosus

Intervention Type: OTHER

Population: Patients with systemic lupus erythematosus. Intervention: Identification of the degree of physical activity of patients with systemic lupus erythematosus.

Interventions

Patients with systemic lupus erythematosus

Population: Patients with systemic lupus erythematosus. Intervention: Identification of the degree of physical activity of patients with systemic lupus erythematosus.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with a diagnosis of systemic lupus erythematosus
• Of legal age
• Residents in Spain
• Who sign the informed consent document.

Exclusion Criteria

• Patients dependent in the development of activities of daily living.
• Unable to ambulate without the help of third parties.
• Who have undergone surgery in the last 6 months.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oviedo

OTHER

Sponsor Role: lead

Responsible Party

Ruben Cuesta Barriuso

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rubén Cuesta-Barriuso, PhD

Role: STUDY_DIRECTOR

Universidad de Oviedo

Locations

University of Oviedo

Oviedo, Principality of Asturias, Spain

Countries

Spain

Central Contacts

Rubén Cuesta-Barriuso, PhD

Role: CONTACT

cuestaruben@uniovi.es

607547274

Other Identifiers

ActLup

Identifier Type: -

Identifier Source: org_study_id