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System; Lupus ErythematosusNCT05984316

Systemic Lupus Erythematosus

A study testing Exercise in people with System; Lupus Erythematosus and Cognition Disorder, run by Biruni University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 16 years
What is being tested?
Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
2 Aug 2023to 5 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

eylul pinar kisa contact

05321307023

eylulpnr93@gmail.com

Turkey (Türkiye)1 site, 1 recruiting

  • Biruni University

    Istanbul

    Eylül Pınar Kısa

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Exercises Applied With Dual-Duty Approach on Physical and Cognitive Status in Cases With Juvenile-Onset Systemic Lupus Erythematosus

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.

Read more

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.

Being tested
Exercise
Medical subject headings
Lupus Erythematosus, Systemic, Cognition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseOther

    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.

Study groups in NCT05984316
Study groupRoleWhat they receive
exercise groupExperimentalNot described
Receives: Other: Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 0-16. week

Secondary outcomes (4)

  1. 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.

    Measured: 0-16. week

  2. 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.

    Measured: 0-16. week

  3. 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.

    Measured: 0-16. week

  4. 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.

    Measured: 0-16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2023
  2. Study start2 Aug 2023
  3. Primary completion2 Dec 2023 (estimated)
  4. Study completion5 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05984316
Sponsor's protocol ID
SLE
Status last verified
Oct 2023
First submitted
2 Aug 2023
Last updated
18 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40541266

Questions about this trial

What is this clinical trial studying?

A study testing Exercise in people with System; Lupus Erythematosus and Cognition Disorder, run by Biruni University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact eylul pinar kisa (05321307023, eylulpnr93@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cognitive eveluation (time frame: 0-16. week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05984316, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023; AzTrials last refreshed its copy on 27 Oct 2026.

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