Systemic Lupus Erythematosus

• ClinicalTrials.gov Identifier: NCT05984316
• Recruitment Status: Recruiting
• First Posted: August 9, 2023
• Last Update Posted: October 18, 2023
• Sponsor: Biruni University
• Information provided by (Responsible Party): Eylül Pınar KISA, Biruni University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
System; Lupus Erythematosus; Cognition Disorder; Autoimmune	Other: Exercise	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effect of Exercises Applied With Dual-Duty Approach on Physical and Cognitive Status in Cases With Juvenile-Onset Systemic Lupus Erythematosus
• Actual Study Start Date: August 2, 2023
• Estimated Primary Completion Date: December 2, 2023
• Estimated Study Completion Date: December 5, 2023

Arms and Interventions

Arm

Intervention/treatment

Experimental: exercise group

Other: Exercise; 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.

Outcome Measures

Primary Outcome Measures :

1. Cognitive eveluation [ Time Frame: 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.

Secondary Outcome Measures :

1. Pain assessment [ Time Frame: 0-16. week ]

   Part One: There are 15 descriptive word groups in this part. Of these, 11 evaluate the sensory dimension of the pain, and 4 evaluate the perceptual dimension. These descriptors are rated on an intensity scale from 0 to 3 (0= none, 1= Mild, 2=Moderate, 3= Excess). In the first part of the scale, a total of 3 pain scores are obtained: sensory pain score, perceptual pain score and total pain score.

   Part Two: In the second part of the form, there are five word groups ranging from "mild pain" to "unbearable pain" to determine the severity of the patient's pain.

   In Part Three: In the third part, the patient's current pain intensity is evaluated using a visual comparison scale.

2. Disease activity [ Time Frame: 0-16. week ]
   Disease activity of children will be evaluated with the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI). Originally defined in 1992, SLEDAI is a global index of 24 clinical and laboratory variables with distinct differences reflecting disease activity over the past 10 days. Neurological, locomotor, renal, The activity is evaluated in nine systems: mucocutaneous, general, cardiac, respiratory, vascular, and haematological. The maximum score is 105.
3. Activity Assessment [ Time Frame: 0-16. week ]
   It consists of two different parts, the disability index and the discomfort index. Disability index dressing and It consists of 8 parameters including self-care, standing up, eating, walking, hygiene, reaching, holding and activities. A non-applicable answer is available for each question to eliminate bias due to age and growth limitations. The representation score is calculated according to the highest scores answered in that area. Discomfort is assessed by measuring pain with a 15 cm visual analog scale. Parents of the patients told their children's last week A VAS score is made about how much pain they have inside and they are asked to give a score between 0 and 100. Likewise, they are asked to score between 0 and 100 on how much they have been affected by the disease since the onset of the disease. The CHAQ score is calculated by adding the disability and discomfort scores and then dividing by 2. The higher the score, the worse the child's condition.
4. Physical activity assessment [ Time Frame: 0-16 weeks ]
   The physical activity levels of the subjects participating in the study It will be followed by a smart wristband with a physical activity monitor at the beginning and during the training sessions.

Eligibility Criteria

• Ages Eligible for Study: 6 Years to 16 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: eylul pinar kisa; 05321307023; eylulpnr93@gmail.com

Locations

Turkey

Biruni University; Recruiting

Istanbul, Turkey

Contact: Eylül Pınar Kısa

Sponsors and Collaborators

Biruni University

Investigators

• Study Chair: eylul Pinar kısa; Istanbul University - Cerrahpasa (IUC)

More Information

• Responsible Party: Eylül Pınar KISA, PHD, Biruni University
• ClinicalTrials.gov Identifier: NCT05984316
• Other Study ID Numbers: SLE
• First Posted: August 9, 2023
• Last Update Posted: October 18, 2023
• Last Verified: October 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Lupus Erythematosus, Systemic; Cognition Disorders; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Neurocognitive Disorders; Mental Disorders