Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2025-12-29 @ 11:59 PM
Study NCT ID:
NCT06919250
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-09
First Post:
2025-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physical Activity in Patients With Systemic Lupus Erythematosus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 63}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-05-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-04', 'studyFirstSubmitDate': '2025-03-25', 'studyFirstSubmitQcDate': '2025-04-04', 'lastUpdatePostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Measurement of gender', 'timeFrame': 'Screening visit', 'description': 'Gender, a dichotomous variable (Male/Female), will be a possible confounding variable.'}, {'measure': 'Measurement of toxic habits', 'timeFrame': 'Screening visit', 'description': 'Smoking as a toxic habit, dichotomous variable (Yes/No), will be a possible confounding variable.'}, {'measure': 'Assessment of the diagnosis of other pathologies with a questionnaire', 'timeFrame': 'Screening visit', 'description': 'The assessment of the diagnosis of other pathologies will be a possible confounding variable. In the evaluation questionnaire, patients will be able to indicate whether they have been diagnosed with another pathology, with this variable having multiple answers in those cases of patients with different pathologies.'}, {'measure': 'Evaluation of the usual pharmacological treatment received by patients, by means of a specific question in a questionnaire', 'timeFrame': 'Screening visit', 'description': 'The usual pharmacological treatment, a nominal qualitative polytomous variable (glucocorticoids / antimalarials / immunosuppressants), will be a possible confounding variable. This variable will be measured with the evaluation questionnaire, where patients will be able to respond with multiple answers.'}], 'primaryOutcomes': [{'measure': 'Measurement of the degree of physical activity', 'timeFrame': 'Screening visit', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Measurement of health-related quality of life', 'timeFrame': 'Screening visit', 'description': '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).'}, {'measure': 'Measurement of fatigue', 'timeFrame': 'Screening visit', 'description': '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.'}, {'measure': 'Measurement of sleep disorders', 'timeFrame': 'Screening visit', 'description': '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'}, {'measure': 'Measurement of depressive symptoms', 'timeFrame': 'Screening visit', 'description': '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.'}, {'measure': 'Measurement of anxiety symptoms', 'timeFrame': 'Screening visit', 'description': "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."}, {'measure': 'Measurement of age', 'timeFrame': 'Screening visit', 'description': 'The measurement of age, a quantitative variable, will be made taking as a unit the number of years completed.'}, {'measure': 'Measurement of disease activity', 'timeFrame': 'Screening visit', 'description': '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'}, {'measure': 'Measurement of disease damage', 'timeFrame': 'Screening visit', 'description': '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.'}, {'measure': 'Measurement of disease duration', 'timeFrame': 'Screening visit', 'description': 'Measurement of disease duration, a quantitative variable, will be calculated in months completed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Systemic Lupus Erythematosus', 'Physical activity', 'Prevention', 'Physiotherapy'], 'conditions': ['Lupus Erythematosus, Systemic']}, 'descriptionModule': {'briefSummary': '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.\n\nObjective. 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.\n\nMethod. 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.\n\nExpectedresults. 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with systemic lupus erythematosus', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a diagnosis of systemic lupus erythematosus\n* Of legal age\n* Residents in Spain\n* Who sign the informed consent document.\n\nExclusion Criteria:\n\n* Patients dependent in the development of activities of daily living.\n* Unable to ambulate without the help of third parties.\n* Who have undergone surgery in the last 6 months.'}, 'identificationModule': {'nctId': 'NCT06919250', 'briefTitle': 'Physical Activity in Patients With Systemic Lupus Erythematosus', 'organization': {'class': 'OTHER', 'fullName': 'University of Oviedo'}, 'officialTitle': 'Physical Activity and Its Impact on Health in Patients With Systemic Lupus Erythematosus. A Multicenter Cohort Study.', 'orgStudyIdInfo': {'id': 'ActLup'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with systemic lupus erythematosus', 'description': '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.', 'interventionNames': ['Other: Patients with systemic lupus erythematosus']}], 'interventions': [{'name': 'Patients with systemic lupus erythematosus', 'type': 'OTHER', 'description': 'Population: Patients with systemic lupus erythematosus. Intervention: Identification of the degree of physical activity of patients with systemic lupus erythematosus.', 'armGroupLabels': ['Patients with systemic lupus erythematosus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33006', 'city': 'Oviedo', 'state': 'Principality of Asturias', 'country': 'Spain', 'facility': 'University of Oviedo', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}], 'centralContacts': [{'name': 'Rubén Cuesta-Barriuso, PhD', 'role': 'CONTACT', 'email': 'cuestaruben@uniovi.es', 'phone': '607547274'}], 'overallOfficials': [{'name': 'Rubén Cuesta-Barriuso, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidad de Oviedo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oviedo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ruben Cuesta Barriuso', 'investigatorAffiliation': 'University of Oviedo'}}}}