FatigueNCT06652256
Fatigue in Systemic Lupus Erythematosus
An observational study of Fatigue and Systemic Lupus Erthematosus, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fatigue, Systemic Lupus Erthematosus
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Oct 2024to 30 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Being diagnosed with SLE according to the 2019 ACR/EULAR diagnostic criteria
- Being 18 years of age or older
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Fatigue, Systemic Lupus Erthematosus
- Medical subject headings
- Fatigue
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Assesment Scale
It is a scale consisting 10 items. The maximum score is 50. High score indicates high fatigue.
Measured: 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
Measured: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start2 Oct 2024
- Primary completion18 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zülal TATAR, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652256
- Sponsor's protocol ID
- Fatigue
- Status last verified
- Dec 2024
- First submitted
- 17 Oct 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatigue in Systemic Lupus Erythematosus: Which Variables Play a Role?
- ClinicalTrials.gov ID
- NCT06652256
- Acronym / sponsor ID
- Fatigue
- Conditions
- Fatigue, Systemic Lupus Erthematosus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- 18 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 22 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Being diagnosed with SLE according to the 2019 ACR/EULAR diagnostic criteria
- Being 18 years of age or older
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
12 secondary outcomes
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.
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.
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.
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.
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.
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.
Hematological indices
Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fatigue and Systemic Lupus Erthematosus, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.