System Lupus Erythematosus(SLE)NCT07622251
The Effect of Exercise on Cognitive Functions in Individuals With Systemic Lupus Erythematosus
A study testing Exercise in people with System Lupus Erythematosus(SLE), run by Istanbul Galata University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- System Lupus Erythematosus(SLE)
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jun 2026to 10 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- System Lupus Erythematosus(SLE)
- Being tested
- Exercise
- Keywords
- cognitive function, aerobic exercise, systemic lupus erythematosus, disease activity
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Aerobic Exercise + video based games +calisthenics exercise
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Not described |
| exercise group | Experimental | Not described Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini Mental Test
Measured: baseline and 12th week
Secondary outcomes (6)
Stroop Test
Measured: baseline and 12th week
Corsi Block Test
Measured: baseline and 12th week
Wisconsin Card Sorting Test
Measured: baseline and 12th week
Six-Minute Walk Test
Measured: baseline and 12th week
borg scale
Measured: every sessions
Systemic Lupus Erythematosus Disease Activity Index
Measured: baseline and 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start5 Jun 2026 (estimated)
- Primary completion4 Jun 2027 (estimated)
- Study completion10 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for System Lupus Erythematosus(SLE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Galata University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Nejla Uzun, Istanbul Galata University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07622251
- Sponsor's protocol ID
- E-77300296-050.04-16331
- Status last verified
- May 2026
- First submitted
- 10 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sistemik Lupus Eritematozus Tanılı Bireylere Uygulanan Aerobik Egzersizlerin Kognitif Fonksiyonlar ve Hastalık Aktivitesi Üzerine Etkisi
- ClinicalTrials.gov ID
- NCT07622251
- Acronym / sponsor ID
- E-77300296-050.04-16331
- Conditions
- System Lupus Erythematosus(SLE)
- Keywords
- cognitive function, aerobic exercise, systemic lupus erythematosus, disease activity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Istanbul Galata UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 5 Jun 2026 (estimated)
- Primary completion
- 4 Jun 2027 (estimated)
- Study completion
- 10 Aug 2027 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | – |
| exercise group | Experimental | Behavioral: Exercise |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAerobic Exercise + video based games +calisthenics exercise | Behavioural | exercise group |
Primary outcome
Mini Mental Test
Time frame: baseline and 12th week
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with System Lupus Erythematosus(SLE), run by Istanbul Galata 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 6 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: opening soon, as of the sponsor's last update on 3 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact nejla uzun (+905076426043, fizyoterapist_nejla@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini Mental Test (time frame: baseline and 12th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2026.