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Not yet recruiting NCT07622251

The Effect of Exercise on Cognitive Functions in Individuals With Systemic Lupus Erythematosus

No phase Interventional System Lupus Erythematosus(SLE)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exercise.
Who it may be relevant to
Registry conditions: System Lupus Erythematosus(SLE). Basic parameters: 25 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Sistemik Lupus Eritematozus Tanılı Bireylere Uygulanan Aerobik Egzersizlerin Kognitif Fonksiyonlar ve Hastalık Aktivitesi Üzerine Etkisi

Overview

Study Objective: To examine the effect of aerobic exercise on disease activity and cognitive functions in patients diagnosed with SLE. Study Goals: 1. 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. 2. To apply aerobic exercise to SLE patients for three months. 3. To analyze the effects of the aerobic exercise program on disease activity and cognitive functions.

Detailed description

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.

Interventions

  • Behavioral Exercise
    Aerobic Exercise + video based games +calisthenics exercise

Primary outcome measures

  • Mini Mental Test [Time frame: baseline and 12th week]
Secondary outcome measures (6)
  • Stroop Test [Time frame: baseline and 12th week]
  • Corsi Block Test [Time frame: baseline and 12th week]
  • Wisconsin Card Sorting Test [Time frame: baseline and 12th week]
  • Six-Minute Walk Test [Time frame: baseline and 12th week]
  • borg scale [Time frame: every sessions]
  • Systemic Lupus Erythematosus Disease Activity Index [Time frame: baseline and 12th week]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Istanbul Galata University — Istanbul

Identifiers

NCT: NCT07622251 · E-77300296-050.04-16331

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗