Lupus Erythematosus, SystemicNCT07123220
Prognostic Factors for Fatigue in Patients With Systemic Lupus Erythematosus
An observational study of Lupus Erythematosus, Systemic, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
Trial summary
Introduction: Fatigue is a well-established symptom in systemic lupus erythematosus. Depression and anxiety can develop at different stages of systemic lupus erythematosus and their severity can range from mild symptoms to more serious disorders. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Lupus Erythematosus, Systemic
- How many people
- 884 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2025to 31 Dec 2025
- How long will I take part?
- 1 Day
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with systemic lupus erythematosus. A total of 88 patients are expected to be included in this project.
Who may be able to join
- Patients diagnosed with systemic lupus erythematosus.
- Over 18 years of age.
- Who have not had any flare-ups in the last 6 months.
- Who sign the informed consent form.
Who cannot join
- Patients with neurological or cognitive impairments that prevent them from understanding the questionnaires and physical tests.
- Patients who are receiving an intervention (physiotherapy or orthopedic) at the time of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of Prognostic Factors for Fatigue in Patients With Systemic Lupus Erythematosus. A Multicenter Cross-sectional Cohort Study
Introduction: Fatigue is a well-established symptom in systemic lupus erythematosus. Depression and anxiety can develop at different stages of systemic lupus erythematosus and their severity can range from mild symptoms to more serious disorders. Patients with systemic lupus erythematosus may consider fatigue to be a symptom that is more severe than pain, depression, or anxiety.
Objectives: To describe fatigue in patients with systemic lupus erythematosus and identify the best predictive model for fatigue in these patients.
Read more
Methods: Multicenter cross-sectional cohort studies. Eighty-eight patients with systemic lupus erythematosus from different regions of Spain will be included in the studies. The primary variable will be fatigue (Fatigue Assessment Scale), with anxiety (State-Trait Anxiety Inventory) as the dependent variable. The secondary variables will be perceived quality of life (Lupus Quality of Life and 36-Item Short Form Survey Instrument), level of physical activity (International Physical Activity Questionnaire), and the main clinical, sociodemographic, and anthropometric variables.
Expected results: To describe fatigue in patients with systemic lupus erythematosus, as well as the predictive model for fatigue in these patients.
- Conditions
- Lupus Erythematosus, Systemic
- Keywords
- Systemic Lupus Erythematosus, Fatigue, Anxiety, Quality of life, Physical activity
- Medical subject headings
- Lupus Erythematosus, Systemic, Fatigue, Anxiety Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observational group | Patients who meet the selection criteria will be informed of the characteristics, objectives, and risks of the evaluation. They will be provided with patient information and informed consent documents. After confirming that they do not meet any of the exclusion criteria, the dependent and confounding variables of the study will be evaluated. The assessment will be carried out using self-questionnaires that will be sent online to the various associations of patients with systemic lupus erythematosus that are part of the Spanish Lupus Federation. All questionnaire assessments will be carried out by the same physical therapist, following the same assessment protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of fatigue at baseline
Fatigue will be assessed using the Fatigue Assessment Scale. This tool provides information on the physical and psychological aspects of fatigue. This scale is highly reliable. This self-reported questionnaire consists of 10 items with a 5-point Likert response scale. Five items reflect the physical component and five reflect the psychological component. The score range of the scale is 10-50 (the higher the score, the greater the degree of fatigue).
Measured: Baseline
Secondary outcomes (6)
Assessment of anxiety symptoms at baseline
The State-Trait Anxiety Inventory will be used to measure the presence and severity of anxiety symptoms in patients with systemic lupus erythematosus. There are two subscales within this measure: state and trait. The state anxiety scale assesses the current state of anxiety, while the trait anxiety scale assesses relatively stable aspects of the propensity for anxiety. This scale has 40 items, 20 assigned to each of the subscales, with a range of 1 to 4 points (the higher the score, the higher the level of anxiety).
Measured: Baseline
Assessment of quality of life at baseline
Quality of life in patients with systemic lupus erythematosus will be measured using the Spanish version of the Lupus Quality of Life (LupusQoL) questionnaire. This questionnaire consists of 34 items in 8 domains (physical health, emotional health, body image, pain, planning, fatigue, intimate relationships, and burden on others). The questionnaire scores range from 0 (worst quality of life) to 100 (best quality of life).
Measured: Baseline
Assessment of health-related quality of life at baseline
The Spanish version of the Short Form-36 Health Survey (SF-36) questionnaire will be used to measure health-related quality of life. It consists of 36 items that investigate eight dimensions (physical function, physical role, bodily pain, general health, vitality, social function, emotional role, and mental health, including a health transition item). The score ranges from 0 to 100 (better perception of quality of life).
Measured: Baseline
Assessment of physical activity level at baseline
Physical activity level will be assessed using the International Physical Activity Questionnaire (IPAQ). This tool consists of seven questions that inquire about the frequency, duration, and intensity of physical activity performed in the last week. It also assesses the time spent walking and sitting. The results are classified into three categories: low, moderate, and high activity, identifying whether individuals meet the WHO activity recommendations. The unit of measurement is the metabolic equivalent of task (METS), where a higher number of METS indicates greater physical activity.
Measured: Baseline
Assessment of lupus activity index at baseline
The Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) is a widely used tool in the evaluation of systemic lupus erythematosus. This global index assesses disease activity over the last 10 days and consists of 24 items that collect specific manifestations in 9 organs or systems. The SLEDAI score ranges from 0 to 105, with higher scores indicating greater disease activity.
Measured: Baseline
Assessment of cumulative damage in lupus at baseline
The assessment of cumulative damage in patients with systemic lupus erythematosus will be performed using the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SLICC/ACR). The tool includes 12 organ systems and measures irreversible damage from the onset of the disease, regardless of its activity, adverse effects due to treatment, or comorbidities. For damage to be considered, it must have been present for at least six months, thus avoiding confusion with active inflammatory processes. The total index score ranges from 0 to 46, with a higher score indicating a greater degree of cumulative damage.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start1 Sep 2025
- Primary completion13 Nov 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus Erythematosus, SystemicStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 884 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Investigación en Hemofilia y Fisioterapia
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Rubén Cuesta-Barriuso, Investigación en Hemofilia y Fisioterapia
- Investigators
- Rubén Cuesta-Barriuso, PhD, Principal investigator, Universidad de Oviedo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07123220
- Sponsor's protocol ID
- Lup-Obs
- Status last verified
- Aug 2025
- First submitted
- 7 Aug 2025
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Prognostic Factors for Fatigue in Patients With Systemic Lupus Erythematosus. A Multicenter Cross-sectional Cohort Study
- ClinicalTrials.gov ID
- NCT07123220
- Acronym / sponsor ID
- Lup-Obs
- Conditions
- Lupus Erythematosus, Systemic
- Keywords
- Systemic Lupus Erythematosus, Fatigue, Anxiety, Quality of life, Physical activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 884 participants (actual)
- Lead sponsor
- Investigación en Hemofilia y FisioterapiaResearch network
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 13 Nov 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 14 Aug 2025 (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.
Introduction: Fatigue is a well-established symptom in systemic lupus erythematosus. Depression and anxiety can develop at different stages of systemic lupus erythematosus and their severity can range from mild symptoms to more serious disorders. Patients with systemic lupus erythematosus may consider fatigue to be a symptom that is more severe than pain, depression, or anxiety.
Objectives: To describe fatigue in patients with systemic lupus erythematosus and identify the best predictive model for fatigue in these patients.
Methods: Multicenter cross-sectional cohort studies. Eighty-eight patients with systemic lupus erythematosus from different regions of Spain will be included in the studies. The primary variable will be fatigue (Fatigue Assessment Scale), with anxiety (State-Trait Anxiety Inventory) as the dependent variable. The secondary variables will be perceived quality of life (Lupus Quality of Life and 36-Item Short Form Survey Instrument), level of physical activity (International Physical Activity Questionnaire), and the main clinical, sociodemographic, and anthropometric variables.
Expected results: To describe fatigue in patients with systemic lupus erythematosus, as well as the predictive model for fatigue in these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational group | – | –Patients who meet the selection criteria will be informed of the characteristics, objectives, and risks of the evaluation. They will be provided with patient information and informed consent documents. After confirming that they do not meet any of the exclusion criteria, the dependent and confounding variables of the study will be evaluated. The assessment will be carried out using self-questionnaires that will be sent online to the various associations of patients with systemic lupus erythematosus that are part of the Spanish Lupus Federation. All questionnaire assessments will be carried out by the same physical therapist, following the same assessment protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with systemic lupus erythematosus. A total of 88 patients are expected to be included in this project.
Key inclusion criteria (4 listed)
- Patients diagnosed with systemic lupus erythematosus.
- Over 18 years of age.
- Who have not had any flare-ups in the last 6 months.
- Who sign the informed consent form.
Key exclusion criteria (2 listed)
- Patients with neurological or cognitive impairments that prevent them from understanding the questionnaires and physical tests.
- Patients who are receiving an intervention (physiotherapy or orthopedic) at the time of the study.
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
Assessment of fatigue at baseline
Time frame: Baseline
Fatigue will be assessed using the Fatigue Assessment Scale. This tool provides information on the physical and psychological aspects of fatigue. This scale is highly reliable. This self-reported questionnaire consists of 10 items with a 5-point Likert response scale. Five items reflect the physical component and five reflect the psychological component. The score range of the scale is 10-50 (the higher the score, the greater the degree of fatigue).
6 secondary outcomes
Assessment of anxiety symptoms at baseline
Time frame: Baseline
Assessment of quality of life at baseline
Time frame: Baseline
Assessment of health-related quality of life at baseline
Time frame: Baseline
Assessment of physical activity level at baseline
Time frame: Baseline
Assessment of lupus activity index at baseline
Time frame: Baseline
Assessment of cumulative damage in lupus at baseline
Time frame: Baseline
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 13 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Rubén Cuesta-Barriuso, PhD principal investigator
Universidad de Oviedo
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 Lupus Erythematosus, Systemic, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
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 4 inclusion and 2 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 13 Feb 2026. 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 Spain. 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?
Assessment of fatigue at baseline (time frame: Baseline). 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 13 Feb 2026.