Systemic Lupus Erythematosus

NCT05984316 | Unknown

• 1 other identifier: SLE
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Systemic lupus erythematosus (SLE) is a chronic autoimmune and inflammatory disease. The pathogenesis of SLE results from interactions between genes, hormones, and the environment; however, the exact etiology is unknown. SLE can affect many organs and systems, including the musculoskeletal, hematological, renal, neuropsychiatric, cardiovascular and pulmonary systems, and skin. Non-specific general complaints such as malaise, fatigue, arthralgia, anxiety, depression, fever, and weight loss are evident at the onset of the disease and during the activation periods. Patients experience hopelessness due to the complexity of the symptoms and the chronic and progressive nature of the disease, and they experience deterioration in their quality of life due to the interaction of anxiety and depression findings with other symptoms. SLE is a difficult disease to manage because of the different organ and system involvement processes. In addition, these symptoms of the disease and the nature of chronic pain, including central sensitization, cause it to accompany a process that is affected by the mood of the person. Some patients present to a rheumatologist with mild symptoms, while others may present with severe, life-threatening symptoms. The onset of the disease before the age of 18 is defined as childhood onset (juvenile). Childhood-onset SLE accounts for approximately 1/5 of SLE patients. It is known that the main mechanism in the formation of the disease is the production of more than one autoantibody. Although childhood SLE (jSLE) appears to be basically the same disease with similar etiology, pathogenesis, and laboratory findings as in adults, there are differences in the frequency and severity of clinical manifestations. In this respect, the clearest finding is that children with SLE have greater disease severity and earlier disease-related organ damage than adults with SLE. Studies on the disease show that patients with jSLE have not only physical but also cognitive effects. The aim of our study is to examine the effects of exercises applied with a dual-task approach on patients' physical and cognitive status in jSLE cases.

Conditions

System; Lupus Erythematosus; Cognition Disorder; Autoimmune

Outcome Measures

Primary Outcomes (1)

• Cognitive eveluation

  Children's cognitive level will be evaluated with the Montreal Cognitive Assessment (MoCA), a rapid screening test for mild cognitive impairment. MoCA assesses different cognitive functions. These; attention and concentration, executive functions, memory, language, visual construction skills, abstract thinking, calculation and orientation. MoCA takes about 10 minutes to apply. The highest total score that can be obtained from the test is 30. Accordingly, a score of 21 points or more is considered normal.

  0-16. week

Secondary Outcomes (4)

• Pain assessment

  0-16. week

• Disease activity

  0-16. week

• Activity Assessment

  0-16. week

• Physical activity assessment

  0-16 weeks

Study Arms (1)

exercise group

EXPERIMENTAL

Other: Exercise

Interventions

Exercise OTHER

Dual task exercises are defined as the appropriate direction of attention during two activities performed at the same time. Dual task performance is required during many activities in daily life. Multitasking is complicated to understand because it is divided into social, physical, and psychological branches. The simultaneous occurrence of movement and cognitive processes is seen as a part of social participation. Considering that one task affects the other, dual task is defined as the simultaneous performance of two tasks that can be performed independently, can be evaluated separately, and have different purposes. Each task must be incompatible and measurable, achievable alone or in different combinations. The increased need for information processing alone does not constitute dual-tasking.

exercise group

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients aged 6-16 years diagnosed with jSLE by a pediatric rheumatologist
• Those who have had the disease for at least one year
• Those whose medical treatments are in a stable period
• Patients willing to be rehabilitated and able to adapt to the study

You may not qualify if:

• Cases older than 16 years old diagnosed with jSLE
• Patients with initiation of multi-organ failure
• Those whose medical treatments are in flux
• Wanting to leave the study
• Not participating in assessments
• Not attending treatment programs regularly
• Not being able to adapt to treatment programs at the cognitive level

Sponsors & Collaborators

• Biruni University: lead

Study Sites (1)

Biruni University

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Kisa EP, Sahin S, Leblebici G, Tonyali IY, Balci G, Dilek S, Aslan E, Tarakci E, Kasapcopur O. Effects of dual-task exercises on cognitive status, disease activity and quality of life in childhood-onset systemic lupus erythematosus. Lupus Sci Med. 2025 Jun 19;12(1):e001453. doi: 10.1136/lupus-2024-001453.

  PMID: 40541266 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Cognition Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• eylul Pinar kısa

  Istanbul University - Cerrahpasa

  STUDY CHAIR

Central Study Contacts

eylul pinar kisa

CONTACT

05321307023; eylulpnr93@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: August 9, 2023
• Study Start: August 2, 2023
• Primary Completion: December 2, 2023
• Study Completion: December 5, 2023
• Last Updated: October 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)