Clinical trial NCT06919250: Physical Activity in Patients With Systemic Lupus Erythematosus
Official title: Physical Activity and Its Impact on Health in Patients With Systemic Lupus Erythematosus. A Multicenter Cohort Study.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Lupus Erythematosus, Systemic
Keywords: Systemic Lupus Erythematosus
Physical activity
Prevention
Physiotherapy
Lead sponsor: University of Oviedo
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with systemic lupus erythematosus

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.


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.

Primary outcomes:
measure: Measurement of the degree of physical activity
timeFrame: Screening visit
Secondary outcomes:
measure: Measurement of health-related quality of life
timeFrame: Screening visit
measure: Measurement of fatigue
timeFrame: Screening visit
measure: Measurement of sleep disorders
timeFrame: Screening visit
measure: Measurement of depressive symptoms
timeFrame: Screening visit
measure: Measurement of anxiety symptoms
timeFrame: Screening visit
measure: Measurement of age
timeFrame: Screening visit
measure: Measurement of disease activity
timeFrame: Screening visit
measure: Measurement of disease damage
timeFrame: Screening visit
measure: Measurement of disease duration
timeFrame: Screening visit
Other outcomes:
measure: Measurement of gender
timeFrame: Screening visit
measure: Measurement of toxic habits
timeFrame: Screening visit
measure: Assessment of the diagnosis of other pathologies with a questionnaire
timeFrame: Screening visit
measure: Evaluation of the usual pharmacological treatment received by patients, by means of a specific question in a questionnaire
timeFrame: Screening visit
Locations:
city: Oviedo
country: Spain
facility: University of Oviedo
state: Asturias
Study officials:
affiliation: Universidad de Oviedo
name: Rubén Cuesta-Barriuso, PhD
role: STUDY_DIRECTOR
References: