Physical Activity in Patients With Systemic Lupus Erythematosus

Официальное название

Physical Activity and Its Impact on Health in Patients With Systemic Lupus Erythematosus. A Multicenter Cohort Study.

Обзор

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Measurement of the degree of physical activity [Срок оценки: Screening visit]

Вторичные конечные точки (9)

• Measurement of health-related quality of life [Срок оценки: Screening visit]
• Measurement of fatigue [Срок оценки: Screening visit]
• Measurement of sleep disorders [Срок оценки: Screening visit]
• Measurement of depressive symptoms [Срок оценки: Screening visit]
• Measurement of anxiety symptoms [Срок оценки: Screening visit]
• Measurement of age [Срок оценки: Screening visit]
• Measurement of disease activity [Срок оценки: Screening visit]
• Measurement of disease damage [Срок оценки: Screening visit]
• Measurement of disease duration [Срок оценки: Screening visit]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Испания · 1 центр

• University of Oviedo — Oviedo

Идентификаторы

NCT: NCT06919250 · ActLup

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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