- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07622251
The Effect of Exercise on Cognitive Functions in Individuals With Systemic Lupus Erythematosus
30. maj 2026 opdateret af: Nejla Uzun, Istanbul Galata University
Sistemik Lupus Eritematozus Tanılı Bireylere Uygulanan Aerobik Egzersizlerin Kognitif Fonksiyonlar ve Hastalık Aktivitesi Üzerine Etkisi
Study Objective:
To examine the effect of aerobic exercise on disease activity and cognitive functions in patients diagnosed with SLE. Study Goals:
- To conduct comprehensive pre- and post-treatment (after 12 weeks) evaluations of SLE patients included in the study, and to determine their disease activity and cognitive levels.
- To apply aerobic exercise to SLE patients for three months.
- To analyze the effects of the aerobic exercise program on disease activity and cognitive functions.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Systemic lupus erythematosus (SLE) is an autoimmune disease characterized by exacerbation and remission phases, affecting many organs, tissues, and systems, including the musculoskeletal system, as a result of increased autoantibody production and immune complex formation.
The disease can manifest with a wide range of clinical features, including symptoms such as fatigue, fever, weight loss or weight gain, as well as arthritis or arthralgia, mucocutaneous lesions with a characteristic butterfly rash, alopecia, oral ulcers, cardiac involvement, vasculitis, Raynaud's phenomenon, nephritis, gastrointestinal symptoms, neuropsychiatric symptoms, and hematological abnormalities.
In addition to these symptoms, cognitive dysfunction is common in SLE at all ages.
Studies in the literature have highlighted the impact on many cognitive functions in SLE.
Attention, memory, and verbal fluency have been identified as the most affected functions.
In inflammatory rheumatic diseases, regular physical activity, consisting of aerobic exercises and strengthening programs, is known to have a long-term anti-inflammatory effect.
Exercise, in particular, has been shown to be a safe method for improving many symptoms in SLE, including health-related quality of life, depressive symptoms, or, more importantly, fatigue.
The 2018 EULAR recommendations suggest that for individuals with inflammatory arthritis and osteoarthritis, aerobic training intensity should be at least 30 minutes, 5 days a week (150 minutes per week with intervals as needed), at moderate intensity (starting at 40-50% of VO2 max and gradually progressing to 50-85% of target VO2 max if the patient has high fatigue), including the use of large muscle groups, and performed without exacerbating the patient's existing fatigue complaints.
Virtual reality-based rehabilitation, on the other hand, involves interaction through smell, sound, and touch in a computer-generated environment using three-dimensional computer simulations to create realistic events and objects.
Another aspect of exercise that has attracted attention in recent years is its effectiveness on cognitive functions.
Exercise is increasingly recognized as a promising non-pharmacological method for preserving, improving, and even preventing the decline of human cognitive functions.
Research examining the effectiveness of exercise on cognitive functions has focused on specific age groups and populations.
These studies primarily focus on diseases such as Parkinson's, Alzheimer's, Dementia, and Mild Cognitive Impairment.
Looking at studies examining the effectiveness of exercise on cognitive functions in rheumatological diseases, improvement on the Montreal Cognitive Assessment Scale was found in patients with Rheumatoid Arthritis who underwent only one of the following exercises for three months: walking, cycling, or swimming.
According to our research, studies examining the effectiveness of aerobic exercise on cognitive functions in rheumatoid diseases are quite limited.
No studies investigating the combined effectiveness of aerobic exercise on cognitive functions, whether applied alone or in combination, were found in patients with SLE.
The aim of this study is to examine the effect of aerobic exercise on disease activity and cognitive functions in patients diagnosed with SLE.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
38
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: nejla uzun
- Telefonnummer: +905076426043
- E-mail: fizyoterapist_nejla@hotmail.com
Studiesteder
-
-
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Istanbul, Tyrkiet (Türkiye)
- Istanbul Galata University
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Having been diagnosed with SLE at least one year prior according to the American Rheumatology Association (ACR) diagnostic criteria
- Being between 25-65 years of age
- Not having received a neuropsychiatric diagnosis
- Having medication adjusted and being on stable medication for 3 months
- Not being involved in a regular exercise program
- Having a Mini Mental Test score lower than 26.
Exclusion Criteria:
- History of secondary rheumatic disease
- Presence of active acute or chronic infection,
- Body mass index (BMI) ≥ 30 kg/m2,
- Acute renal failure,
- Cardiac and pulmonary involvement,
- Presence of musculoskeletal and joint disorders that prevent exercise testing,
- Pregnancy
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Kontrolgruppe
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|
|
Eksperimentel: træningsgruppe
|
Aerobic Exercise + video based games +calisthenics exercise
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Mini Mental Test
Tidsramme: baseline and 12th week
|
baseline and 12th week
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Stroop Test
Tidsramme: baseline and 12th week
|
baseline and 12th week
|
|
Corsi Block Test
Tidsramme: baseline and 12th week
|
baseline and 12th week
|
|
Wisconsin Card Sorting Test
Tidsramme: baseline and 12th week
|
baseline and 12th week
|
|
Six-Minute Walk Test
Tidsramme: baseline and 12th week
|
baseline and 12th week
|
|
borg scale
Tidsramme: every sessions
|
every sessions
|
|
Systemic Lupus Erythematosus Disease Activity Index
Tidsramme: baseline and 12th week
|
baseline and 12th week
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
5. juni 2026
Primær færdiggørelse (Anslået)
4. juni 2027
Studieafslutning (Anslået)
10. august 2027
Datoer for studieregistrering
Først indsendt
10. maj 2026
Først indsendt, der opfyldte QC-kriterier
30. maj 2026
Først opslået (Faktiske)
3. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- E-77300296-050.04-16331
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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Kliniske forsøg med Systemisk Lupus Erythematosus(SLE)
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Progentec Diagnostics, Inc.Oklahoma Center for the Advancement of Science and TechnologyUkendtSLE | Lupus erythematosus | System; Lupus erythematosus | Lupus FlareForenede Stater
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Hope Biosciences Research FoundationHope BiosciencesIkke længere tilgængeligSystem; Lupus erythematosusForenede Stater
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LiveKidney.BioMedical University of South Carolina; Galilee CBRRekrutteringSystemisk lupus erythematosus | SLE | Systemisk lupus erythematosus (SLE) | Lupus | Systemisk Lupus ErthematosusForenede Stater
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Ventus Therapeutics U.S., Inc.RekrutteringSystemisk lupus erythematosus | SLE | Kutan lupus erythematosus (CLE) | CLE | SLE (systemisk lupus)Forenede Stater, Frankrig, Sydafrika, Bulgarien, Georgien, Ungarn, Polen, Spanien
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Cullinan Therapeutics Inc.RekrutteringSLE | SLE (systemisk lupus)Forenede Stater, Australien, Georgien, Bulgarien, Moldova, Rumænien
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University of Sao Paulo General HospitalFundação de Amparo à Pesquisa do Estado de São PauloAfsluttetSystemisk lupus erythematosus (SLE) | Kutan Lupus | Juvenil SLEBrasilien
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EMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, GermanyRekrutteringSystemisk lupus erythematosus (SLE) | Kutan lupus erythematosus (CLE)Forenede Stater
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HC Biopharma Inc.Ikke rekrutterer endnuSystemisk lupus erythematosus (SLE) | Kutan lupus erythematosus (CLE)Kina
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EMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, GermanyIkke rekrutterer endnuSystemisk lupus erythematosus (SLE) | Kutan lupus erythematosus (CLE)Forenede Stater
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AbbVie (prior sponsor, Abbott)AfsluttetLupus erythematosusForenede Stater, Tyskland, Mexico, Puerto Rico