- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07622251
The Effect of Exercise on Cognitive Functions in Individuals With Systemic Lupus Erythematosus
30 de mayo de 2026 actualizado por: Nejla Uzun, Istanbul Galata University
Sistemik Lupus Eritematozus Tanılı Bireylere Uygulanan Aerobik Egzersizlerin Kognitif Fonksiyonlar ve Hastalık Aktivitesi Üzerine Etkisi
Study Objective:
To examine the effect of aerobic exercise on disease activity and cognitive functions in patients diagnosed with SLE. Study Goals:
- To conduct comprehensive pre- and post-treatment (after 12 weeks) evaluations of SLE patients included in the study, and to determine their disease activity and cognitive levels.
- To apply aerobic exercise to SLE patients for three months.
- To analyze the effects of the aerobic exercise program on disease activity and cognitive functions.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
Systemic lupus erythematosus (SLE) is an autoimmune disease characterized by exacerbation and remission phases, affecting many organs, tissues, and systems, including the musculoskeletal system, as a result of increased autoantibody production and immune complex formation.
The disease can manifest with a wide range of clinical features, including symptoms such as fatigue, fever, weight loss or weight gain, as well as arthritis or arthralgia, mucocutaneous lesions with a characteristic butterfly rash, alopecia, oral ulcers, cardiac involvement, vasculitis, Raynaud's phenomenon, nephritis, gastrointestinal symptoms, neuropsychiatric symptoms, and hematological abnormalities.
In addition to these symptoms, cognitive dysfunction is common in SLE at all ages.
Studies in the literature have highlighted the impact on many cognitive functions in SLE.
Attention, memory, and verbal fluency have been identified as the most affected functions.
In inflammatory rheumatic diseases, regular physical activity, consisting of aerobic exercises and strengthening programs, is known to have a long-term anti-inflammatory effect.
Exercise, in particular, has been shown to be a safe method for improving many symptoms in SLE, including health-related quality of life, depressive symptoms, or, more importantly, fatigue.
The 2018 EULAR recommendations suggest that for individuals with inflammatory arthritis and osteoarthritis, aerobic training intensity should be at least 30 minutes, 5 days a week (150 minutes per week with intervals as needed), at moderate intensity (starting at 40-50% of VO2 max and gradually progressing to 50-85% of target VO2 max if the patient has high fatigue), including the use of large muscle groups, and performed without exacerbating the patient's existing fatigue complaints.
Virtual reality-based rehabilitation, on the other hand, involves interaction through smell, sound, and touch in a computer-generated environment using three-dimensional computer simulations to create realistic events and objects.
Another aspect of exercise that has attracted attention in recent years is its effectiveness on cognitive functions.
Exercise is increasingly recognized as a promising non-pharmacological method for preserving, improving, and even preventing the decline of human cognitive functions.
Research examining the effectiveness of exercise on cognitive functions has focused on specific age groups and populations.
These studies primarily focus on diseases such as Parkinson's, Alzheimer's, Dementia, and Mild Cognitive Impairment.
Looking at studies examining the effectiveness of exercise on cognitive functions in rheumatological diseases, improvement on the Montreal Cognitive Assessment Scale was found in patients with Rheumatoid Arthritis who underwent only one of the following exercises for three months: walking, cycling, or swimming.
According to our research, studies examining the effectiveness of aerobic exercise on cognitive functions in rheumatoid diseases are quite limited.
No studies investigating the combined effectiveness of aerobic exercise on cognitive functions, whether applied alone or in combination, were found in patients with SLE.
The aim of this study is to examine the effect of aerobic exercise on disease activity and cognitive functions in patients diagnosed with SLE.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
38
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: nejla uzun
- Número de teléfono: +905076426043
- Correo electrónico: fizyoterapist_nejla@hotmail.com
Ubicaciones de estudio
-
-
-
Istanbul, Turquía (Türkiye)
- Istanbul Galata University
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Having been diagnosed with SLE at least one year prior according to the American Rheumatology Association (ACR) diagnostic criteria
- Being between 25-65 years of age
- Not having received a neuropsychiatric diagnosis
- Having medication adjusted and being on stable medication for 3 months
- Not being involved in a regular exercise program
- Having a Mini Mental Test score lower than 26.
Exclusion Criteria:
- History of secondary rheumatic disease
- Presence of active acute or chronic infection,
- Body mass index (BMI) ≥ 30 kg/m2,
- Acute renal failure,
- Cardiac and pulmonary involvement,
- Presence of musculoskeletal and joint disorders that prevent exercise testing,
- Pregnancy
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: Grupo de control
|
|
|
Experimental: grupo de ejercicio
|
Aerobic Exercise + video based games +calisthenics exercise
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Mini Mental Test
Periodo de tiempo: baseline and 12th week
|
baseline and 12th week
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Stroop Test
Periodo de tiempo: baseline and 12th week
|
baseline and 12th week
|
|
Corsi Block Test
Periodo de tiempo: baseline and 12th week
|
baseline and 12th week
|
|
Wisconsin Card Sorting Test
Periodo de tiempo: baseline and 12th week
|
baseline and 12th week
|
|
Six-Minute Walk Test
Periodo de tiempo: baseline and 12th week
|
baseline and 12th week
|
|
borg scale
Periodo de tiempo: every sessions
|
every sessions
|
|
Systemic Lupus Erythematosus Disease Activity Index
Periodo de tiempo: baseline and 12th week
|
baseline and 12th week
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
5 de junio de 2026
Finalización primaria (Estimado)
4 de junio de 2027
Finalización del estudio (Estimado)
10 de agosto de 2027
Fechas de registro del estudio
Enviado por primera vez
10 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
30 de mayo de 2026
Publicado por primera vez (Actual)
3 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
30 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del tejido conectivo
- Enfermedades autoinmunes
- Enfermedades del sistema inmunológico
- Enfermedades de la piel y del tejido conectivo
- Lupus Eritematoso Sistémico
- Actividad motora
- Movimiento
- Fenómenos fisiológicos musculoesqueléticos
- Fenómenos fisiológicos musculoesqueléticos y neuronales
- Ejercicio
Otros números de identificación del estudio
- E-77300296-050.04-16331
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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