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:

  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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control group
Experimental: exercise group
Behavioral: Exercise
Aerobic Exercise + video based games +calisthenics exercise

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Mini Mental Test
Time Frame: baseline and 12th week
baseline and 12th week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul Galata University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Scientific and Technological Research Council of Turkey

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 5, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 4, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 10, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 3, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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