Clinical trial NCT05984316: Systemic Lupus Erythematosus
Official title: The Effect of Exercises Applied With Dual-Duty Approach on Physical and Cognitive Status in Cases With Juvenile-Onset Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: System; Lupus Erythematosus
Cognition Disorder
Autoimmune
Lead sponsor: Biruni University
Sponsor class: OTHER
First posted: 2023-08-09
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Cognitive eveluation
timeFrame: 0-16. week
Secondary outcomes:
measure: Pain assessment
timeFrame: 0-16. week
measure: Disease activity
timeFrame: 0-16. week
measure: Activity Assessment
timeFrame: 0-16. week
measure: Physical activity assessment
timeFrame: 0-16 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Biruni University
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: eylul Pinar kısa
role: STUDY_CHAIR
References: