The Effect of Exercises Applied With Dual-Duty Approach on Physical and Cognitive Status in Cases With Juvenile-Onset Systemic Lupus Erythematosus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Cognitive eveluation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Cognitive eveluation
时间窗: 0-16. week
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.
次要结局
- Disease activity(0-16. week)
- Physical activity assessment(0-16 weeks)
- Pain assessment(0-16. week)
- Activity Assessment(0-16. week)
研究者
Eylül Pınar KISA
PHD
Biruni University