Clinical trial NCT06652256: Fatigue in Systemic Lupus Erythematosus
Official title: Fatigue in Systemic Lupus Erythematosus: Which Variables Play a Role?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fatigue
Systemic Lupus Erthematosus
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2024-10-22
Enrollment: 39
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Fatigue Assesment Scale
timeFrame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
measure: FACIT Fatigue Scale
timeFrame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Secondary outcomes:
measure: Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire (BETY-BQ)
timeFrame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
measure: Short Form 36 (SF-36) Health Survey
timeFrame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
measure: HEALTH ASSESSMENT QUESTIONNAIRE (HAQ)
timeFrame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
measure: Routine blood test results
timeFrame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
measure: Routine Blood Test Results
timeFrame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
measure: Routine Blood Test Results
timeFrame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
measure: Hematological indices
timeFrame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
measure: Routine Blood Test Results
timeFrame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
measure: Routine Blood Test Results
timeFrame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
measure: Routine Blood Test Results
timeFrame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
measure: Routine Blood Test Results
timeFrame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
measure: Routine Blood Test Results
timeFrame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
References: