NCT07622251

Brief Summary

Study Objective: To examine the effect of aerobic exercise on disease activity and cognitive functions in patients diagnosed with SLE. Study Goals:

  1. 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. 2.To apply aerobic exercise to SLE patients for three months.
  3. 3.To analyze the effects of the aerobic exercise program on disease activity and cognitive functions.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
14mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Jun 2026Aug 2027

First Submitted

Initial submission to the registry

May 10, 2026

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 3, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

June 5, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2027

Last Updated

June 3, 2026

Status Verified

May 1, 2026

Enrollment Period

12 months

First QC Date

May 10, 2026

Last Update Submit

May 30, 2026

Conditions

Keywords

cognitive functionaerobic exercisesystemic lupus erythematosusdisease activity

Outcome Measures

Primary Outcomes (1)

  • Mini Mental Test

    baseline and 12th week

Secondary Outcomes (6)

  • Stroop Test

    baseline and 12th week

  • Corsi Block Test

    baseline and 12th week

  • Wisconsin Card Sorting Test

    baseline and 12th week

  • Six-Minute Walk Test

    baseline and 12th week

  • borg scale

    every sessions

  • +1 more secondary outcomes

Study Arms (2)

Control group

NO INTERVENTION

exercise group

EXPERIMENTAL
Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

Aerobic Exercise + video based games +calisthenics exercise

exercise group

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Galata University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Exercise

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 10, 2026

First Posted

June 3, 2026

Study Start

June 5, 2026

Primary Completion (Estimated)

June 4, 2027

Study Completion (Estimated)

August 10, 2027

Last Updated

June 3, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations