Lupus Erythematosus, SystemicNCT06919250
Physical Activity in Patients With Systemic Lupus Erythematosus
An observational study of Lupus Erythematosus, Systemic, run by University of Oviedo at 1 site in Spain.
Trial summary
Background. Systemic lupus erythematosus is a chronic autoimmune disease. Among its main clinical manifestations are musculoskeletal symptoms such as myopathies, arthritis, arthralgias or osteonecrosis. Physical activity can improve the perception of quality of life and well-being of these patients. Objective. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lupus Erythematosus, Systemic
- What is being tested?
- Patients with systemic lupus erythematosus
- How many people
- 63 participants
- Where
- 1 siteSpain
- Study dates
- 31 Mar 2025to 20 May 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with systemic lupus erythematosus
Who may be able to join
- Patients with a diagnosis of systemic lupus erythematosus
- Of legal age
- Residents in Spain
- Who sign the informed consent document.
Who cannot join
- Patients dependent in the development of activities of daily living.
- Unable to ambulate without the help of third parties.
- Who have undergone surgery in the last 6 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Physical Activity and Its Impact on Health in Patients With Systemic Lupus Erythematosus. A Multicenter Cohort Study.
Background. Systemic lupus erythematosus is a chronic autoimmune disease. Among its main clinical manifestations are musculoskeletal symptoms such as myopathies, arthritis, arthralgias or osteonecrosis. Physical activity can improve the perception of quality of life and well-being of these patients.
Objective. To assess the degree of physical activity in patients with systemic lupus erythematosus, and to identify the main clinical, sociodemographic and anthropometric variables that influence it.
Read more
Method. Ambispective cohort study. Sixty-three patients with systemic lupus erythematosus will be recruited. The primary variable will be the degree of physical activity (International Physical Activity Questionnaire). Secondary and modifying variables will be: fatigue (Fatigue Assessment Scale), health-related quality of life (Short Form-36 Health Survey), sleep disorders (Pittsburgh Sleep Quality Index), depressive (Beck Depression Inventory -II) and anxiety symptoms (Hamilton Anxiety Rating Scale), age, and disease activity, duration and damage. Possible confounding variables will be sex, toxic habits (smoking), diagnosis of other pathologies and exposure to therapy. In the analysis, the degree of physical activity of patients with lupus erythematosus will be calculated and a multiple regression analysis will be performed to evaluate the predictive model that best fits the degree of activity of these patients.
Expectedresults. To identify the degree of physical activity of patients with systemic lupus erythematosus and to identify the predictive model of physical activity in these patients.
- Conditions
- Lupus Erythematosus, Systemic
- Being tested
- Patients with systemic lupus erythematosus
- Keywords
- Systemic Lupus Erythematosus, Physical activity, Prevention, Physiotherapy
- Medical subject headings
- Lupus Erythematosus, Systemic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with systemic lupus erythematosusOther
Population: Patients with systemic lupus erythematosus. Intervention: Identification of the degree of physical activity of patients with systemic lupus erythematosus.
| Study group | Role | What they receive |
|---|---|---|
| Patients with systemic lupus erythematosus | Patients with systemic lupus erythematosus who will participate through an interview format with closed questions where no data will be collected that would allow identification of the subjects. Receives: Other: Patients with systemic lupus erythematosus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the degree of physical activity
The degree of physical activity will be assessed with the International Physical Activity Questionnaire (IPAQ). This tool assesses the time spent walking and sitting. The results are classified into three categories: low, moderate and high activity. The unit of measurement is the units of measurement of the metabolic rate (METS), where the higher the number of METS, the greater the physical activity.
Measured: Screening visit
Secondary outcomes (9)
Measurement of health-related quality of life
Health-related quality of life will be measured with the Short Form-36 Health Survey questionnaire. It is composed of 36 items that inquire about 8 dimensions (physical function, physical role, bodily pain, general health, vitality, social function, emotional role, and mental health, including a health transition item). The score range is from 0 to 100 (best perception of quality of life).
Measured: Screening visit
Measurement of fatigue
The degree of fatigue will be measured with the Fatigue Assessment Scale questionnaire. This instrument assesses perceived mental and physical fatigue, consisting of 10 items. The score varies between 10 and 50 points, where the higher the score the higher the level of fatigue.
Measured: Screening visit
Measurement of sleep disorders
Sleep disorders will be measured with the Pittsburgh Sleep Quality Index. This questionnaire examines in 7 dimensions subjective sleep quality, sleep latency and duration, and sleep efficiency and disturbances, use of sleep medications, and daytime dysfunction. It is composed of 19 items. The score range varies from 0 to 21, considering poor sleep quality a score higher than 5 and good sleep quality if it is lower than 5 points
Measured: Screening visit
Measurement of depressive symptoms
The depressive symptoms of the patients included in the study will be assessed with the Beck Depression Inventory. This tool consists of 21 items, grouped into 4 dimensions: emotional, cognitive, motivational and physiological. The scores vary between 0 and 63 points, and a state of absence or minimal depression (0-13 points), mild depression (14-19 points), moderate depression (20-28 points) or severe depression (29-63 points) can be obtained. A cut-off point of 15 points or more is proposed to diagnose depression.
Measured: Screening visit
Measurement of anxiety symptoms
The Hamilton Anxiety Rating Scalewill be used to measure patients' anxiety symptoms. This scale quantifies the severity of anxiety by means of 14 items associated with somatic and psychological symptoms. Based on responses, patients are grouped into three categories: mild or absent anxiety (<17 points), mild-moderate (18 to 24 points) or moderate to severe (25-30 or more). The total score ranges from 0 to 56, where the higher the score, the greater the anxiety.
Measured: Screening visit
Measurement of age
The measurement of age, a quantitative variable, will be made taking as a unit the number of years completed.
Measured: Screening visit
Measurement of disease activity
The measurement of disease activity, a quantitative variable, will be made with the specific scale for patients with Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), with a score from 0 to 105 points
Measured: Screening visit
Measurement of disease damage
The measurement of disease damage, a quantitative variable, will be made with the specific scale for patients with lupus erythematosus sitematosus SLICC Damage Index (SDI), with a score of 0 to 46.
Measured: Screening visit
Measurement of disease duration
Measurement of disease duration, a quantitative variable, will be calculated in months completed.
Measured: Screening visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start31 Mar 2025 (estimated)
- Primary completion28 Apr 2025 (estimated)
- Study completion20 May 2025 (estimated)
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
- 63 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Oviedo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruben Cuesta Barriuso, University of Oviedo
- Investigators
- Rubén Cuesta-Barriuso, PhD, Study director, Universidad de Oviedo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06919250
- Sponsor's protocol ID
- ActLup
- Status last verified
- Mar 2025
- First submitted
- 25 Mar 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity and Its Impact on Health in Patients With Systemic Lupus Erythematosus. A Multicenter Cohort Study.
- ClinicalTrials.gov ID
- NCT06919250
- Acronym / sponsor ID
- ActLup
- Conditions
- Lupus Erythematosus, Systemic
- Keywords
- Systemic Lupus Erythematosus, Physical activity, Prevention, Physiotherapy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- University of OviedoUniversity, hospital or other
- Study start
- 31 Mar 2025 (estimated)
- Primary completion
- 28 Apr 2025 (estimated)
- Study completion
- 20 May 2025 (estimated)
- First posted
- 9 Apr 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.
Background. Systemic lupus erythematosus is a chronic autoimmune disease. Among its main clinical manifestations are musculoskeletal symptoms such as myopathies, arthritis, arthralgias or osteonecrosis. Physical activity can improve the perception of quality of life and well-being of these patients.
Objective. To assess the degree of physical activity in patients with systemic lupus erythematosus, and to identify the main clinical, sociodemographic and anthropometric variables that influence it.
Method. Ambispective cohort study. Sixty-three patients with systemic lupus erythematosus will be recruited. The primary variable will be the degree of physical activity (International Physical Activity Questionnaire). Secondary and modifying variables will be: fatigue (Fatigue Assessment Scale), health-related quality of life (Short Form-36 Health Survey), sleep disorders (Pittsburgh Sleep Quality Index), depressive (Beck Depression Inventory -II) and anxiety symptoms (Hamilton Anxiety Rating Scale), age, and disease activity, duration and damage. Possible confounding variables will be sex, toxic habits (smoking), diagnosis of other pathologies and exposure to therapy. In the analysis, the degree of physical activity of patients with lupus erythematosus will be calculated and a multiple regression analysis will be performed to evaluate the predictive model that best fits the degree of activity of these patients.
Expectedresults. To identify the degree of physical activity of patients with systemic lupus erythematosus and to identify the predictive model of physical activity in these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with systemic lupus erythematosus | – | Other: Patients with systemic lupus erythematosusPatients with systemic lupus erythematosus who will participate through an interview format with closed questions where no data will be collected that would allow identification of the subjects. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with systemic lupus erythematosus
Key inclusion criteria (4 listed)
- Patients with a diagnosis of systemic lupus erythematosus
- Of legal age
- Residents in Spain
- Who sign the informed consent document.
Key exclusion criteria (3 listed)
- Patients dependent in the development of activities of daily living.
- Unable to ambulate without the help of third parties.
- Who have undergone surgery in the last 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients with systemic lupus erythematosusPopulation: Patients with systemic lupus erythematosus. Intervention: Identification of the degree of physical activity of patients with systemic lupus erythematosus. | Other | Patients with systemic lupus erythematosus |
Primary outcome
Measurement of the degree of physical activity
Time frame: Screening visit
The degree of physical activity will be assessed with the International Physical Activity Questionnaire (IPAQ). This tool assesses the time spent walking and sitting. The results are classified into three categories: low, moderate and high activity. The unit of measurement is the units of measurement of the metabolic rate (METS), where the higher the number of METS, the greater the physical activity.
9 secondary outcomes
Measurement of health-related quality of life
Time frame: Screening visit
Measurement of fatigue
Time frame: Screening visit
Measurement of sleep disorders
Time frame: Screening visit
Measurement of depressive symptoms
Time frame: Screening visit
Measurement of anxiety symptoms
Time frame: Screening visit
Measurement of age
Time frame: Screening visit
Measurement of disease activity
Time frame: Screening visit
Measurement of disease damage
Time frame: Screening visit
Measurement of disease duration
Time frame: Screening visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
Rubén Cuesta-Barriuso, PhD study director
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 University of Oviedo 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 3 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: opening soon, as of the sponsor's last update on 9 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rubén Cuesta-Barriuso, PhD (607547274, cuestaruben@uniovi.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the degree of physical activity (time frame: Screening visit). 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 9 Apr 2025.