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Completed

NCT Number: NCT06652256

Fatigue in Systemic Lupus Erythematosus

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.

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Key information

Conditions

Fatigue Pathological Conditions, Signs and Symptoms Signs and Symptoms Systemic Lupus Erthematosus

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Pamukkale University

Denizli, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Fatigue Assesment Scale

    Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

    It is a scale consisting 10 items. The maximum score is 50. High score indicates high fatigue.

  2. FACIT Fatigue Scale

    Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

    It is scale consisting 13 items. Scores range from 0-52. High score indicates low fatigue

Secondary outcomes

  1. Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire (BETY-BQ)

    Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

    It is a scale consist of 30 items. Scores range from 0-120. Higher scores indicate worse biopsychosocial status.

  2. Short Form 36 (SF-36) Health Survey

    Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

    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.

  3. HEALTH ASSESSMENT QUESTIONNAIRE (HAQ)

    Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

    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

  4. Routine blood test results

    Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

    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.

  5. Routine Blood Test Results

    Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

    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.

  6. Routine Blood Test Results

    Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

    The participants' rutin blood test such as aspartate aminotransferase (AST IU/L), alanine aminotransferase (ALT IU/L) will be recorded.

  7. Hematological indices

    Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

    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.

  8. Routine Blood Test Results

    Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

    Procolcytonin (PCT (%)), erythrocyte distribution width (RDW (%)), platelet distribution width (PDW (%)) levels will be recorded.

  9. Routine Blood Test Results

    Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

    Erythrocyte distribution width standard deviation (RDW-SD (fL)) will be recorded.

  10. Routine Blood Test Results

    Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

    C3 complement (g/L) and C4 complement (g/L) levels will be recorded.

  11. Routine Blood Test Results

    Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

    Blood urea nitrogen (BUN (mg/dL)) levels will be recorded.

  12. Routine Blood Test Results

    Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

    Sedimentation (mm/h) will be recorded.

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 22, 2024
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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