- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07622251
The Effect of Exercise on Cognitive Functions in Individuals With Systemic Lupus Erythematosus
May 30, 2026 updated by: 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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
38
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: nejla uzun
- Phone Number: +905076426043
- Email: fizyoterapist_nejla@hotmail.com
Study Locations
-
-
-
Istanbul, Turkey (Türkiye)
- Istanbul Galata University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
|
|
|
Experimental: exercise group
|
Aerobic Exercise + video based games +calisthenics exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Mini Mental Test
Time Frame: baseline and 12th week
|
baseline and 12th week
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Stroop Test
Time Frame: baseline and 12th week
|
baseline and 12th week
|
|
Corsi Block Test
Time Frame: baseline and 12th week
|
baseline and 12th week
|
|
Wisconsin Card Sorting Test
Time Frame: baseline and 12th week
|
baseline and 12th week
|
|
Six-Minute Walk Test
Time Frame: baseline and 12th week
|
baseline and 12th week
|
|
borg scale
Time Frame: every sessions
|
every sessions
|
|
Systemic Lupus Erythematosus Disease Activity Index
Time Frame: baseline and 12th week
|
baseline and 12th week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 5, 2026
Primary Completion (Estimated)
June 4, 2027
Study Completion (Estimated)
August 10, 2027
Study Registration Dates
First Submitted
May 10, 2026
First Submitted That Met QC Criteria
May 30, 2026
First Posted (Actual)
June 3, 2026
Study Record Updates
Last Update Posted (Actual)
June 3, 2026
Last Update Submitted That Met QC Criteria
May 30, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-77300296-050.04-16331
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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