Fatigue in Systemic Lupus Erythematosus

Fatigue in Systemic Lupus Erythematosus: Which Variables Play a Role?

The aim of this study is to investigate the effects of biopsychosocial status, quality of life, functional status and hematological markers on fatigue in individuals with SLE.

Study Overview

• Status: Completed
• Conditions: Fatigue; Systemic Lupus Erthematosus

• Study Type: Observational
• Enrollment (Actual): 39

Contacts and Locations

Study Locations

• Turkey
  • Denizli, Turkey
    • Pamukkale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study will include individuals aged 18 and older who are receiving treatment for SLE at a university hospital in Turkey, and meet the inclusion and exclusion criteria.

Description

Inclusion Criteria:

• Being diagnosed with SLE according to the 2019 ACR/EULAR diagnostic criteria
• Being 18 years of age or older

Exclusion Criteria:

• Not being able to speak or understand Turkish fluently
• Having a psychiatric illness that will affect cooperation
• Heart failure or lung pathology that will affect daily life activities
• Additional autoimmune disease

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue Assesment Scale	It is a scale consisting 10 items. The maximum score is 50. High score indicates high fatigue.	Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
FACIT Fatigue Scale	It is scale consisting 13 items. Scores range from 0-52. High score indicates low fatigue	Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire (BETY-BQ)	It is a scale consist of 30 items. Scores range from 0-120. Higher scores indicate worse biopsychosocial status.	Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Short Form 36 (SF-36) Health Survey	The SF-36 consists of two dimensions, generating a profile of health-related quality of life.These dimensions are: physical health and mental health. Higher scores indicate better health.	Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
HEALTH ASSESSMENT QUESTIONNAIRE (HAQ)	The scale consists of 20 questions and includes 8 activities. The total score is obtained by summing the points earned from 8 activities and then dividing that sum by 8. Higher scores indicate worse functional status	Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Routine blood test results	Participants' routine blood test results such as neutrophil (NEU (K/uL)) , monocyte (MONO (K/uL)), eosinophil (EO (K/uL)), leukocyte (WBC (K/uL)), lymphocyte (LYM (K/uL)), platelet (PLT (K/uL)) will be recorded.	Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Routine Blood Test Results	Participants' routine blood test results such as calcium (Ca (mg/dL)), creatinine (mg/dL), c-reactive protein (CRP (mg/L)), uric acid (mg/dL) will be recorded.	Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Routine Blood Test Results	The participants' rutin blood test such as aspartate aminotransferase (AST IU/L), alanine aminotransferase (ALT IU/L) will be recorded.	Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Hematological indices	Neutrophil/lymphocyte (NLR), monocyte/lymphocyte (MLR), platelet/lymphocyte (PLR), platelet*neutrophil/lymphocyte (systemic inflammatory index), monocyte/platelet (MTO), neutrophil*monocyte/lymphocyte (systemic inflammatory response index), neutrophil*monocyte*platelet/lymphocyte (systemic inflammation aggregate index) obtained from complete blood counts will be calculated and recorded.	Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Routine Blood Test Results	Procolcytonin (PCT (%)), erythrocyte distribution width (RDW (%)), platelet distribution width (PDW (%)) levels will be recorded.	Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Routine Blood Test Results	Erythrocyte distribution width standard deviation (RDW-SD (fL)) will be recorded.	Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Routine Blood Test Results	C3 complement (g/L) and C4 complement (g/L) levels will be recorded.	Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Routine Blood Test Results	Blood urea nitrogen (BUN (mg/dL)) levels will be recorded.	Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Routine Blood Test Results	Sedimentation (mm/h) will be recorded.	Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

Collaborators and Investigators

• Sponsor: Pamukkale University

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2024
• Primary Completion (Actual): November 18, 2024
• Study Completion (Actual): November 30, 2024

Study Registration Dates

• First Submitted: October 17, 2024
• First Submitted That Met QC Criteria: October 21, 2024
• First Posted (Actual): October 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Lupus Erythematosus, Systemic; Fatigue
• Other Study ID Numbers: Fatigue

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No