Systemic Lupus Erythematosus
Primary Purpose
System; Lupus Erythematosus, Cognition Disorder, Autoimmune
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for System; Lupus Erythematosus
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- Biruni UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
exercise group
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Pain assessment
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.
Disease activity
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.
Activity Assessment
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.
Physical activity assessment
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05984316
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2, 2023 (Actual)
Primary Completion Date
December 2, 2023 (Anticipated)
Study Completion Date
December 5, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Biruni University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
System; Lupus Erythematosus, Cognition Disorder, Autoimmune
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
exercise group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cognitive eveluation
Description
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.
Time Frame
0-16. week
Secondary Outcome Measure Information:
Title
Pain assessment
Description
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.
Time Frame
0-16. week
Title
Disease activity
Description
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.
Time Frame
0-16. week
Title
Activity Assessment
Description
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.
Time Frame
0-16. week
Title
Physical activity assessment
Description
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.
Time Frame
0-16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
eylul pinar kisa
Phone
05321307023
Email
eylulpnr93@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
eylul Pinar kısa
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Study Chair
Facility Information:
Facility Name
Biruni University
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eylül Pınar Kısa
12. IPD Sharing Statement
Plan to Share IPD
No
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Systemic Lupus Erythematosus
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