Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-29 @ 11:51 PM
Study NCT ID:
NCT07458932
Status:
RECRUITING
Last Update Posted:
2026-03-09
First Post:
2026-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Physical Activity in Women With Lipedema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065134', 'term': 'Lipedema'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D057185', 'term': 'Sedentary Behavior'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-04', 'studyFirstSubmitDate': '2026-02-26', 'studyFirstSubmitQcDate': '2026-03-04', 'lastUpdatePostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical Activity Level', 'timeFrame': 'Baseline', 'description': 'Physical activity will be assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF). This questionnaire is a seven-item self-report scale that assesses physical activity level over the past seven days. It includes seven questions evaluating the time individuals spend walking, moderate-intensity, vigorous activity, and sitting. A score is obtained as "MET-minutes/week" by multiplying the minutes, days, and MET value (multiples of resting oxygen consumption). The total score is calculated by summing the scores obtained from walking, moderate-intensity activity, and vigorous activity. Based on the total physical activity score, individuals\' physical activity levels can be categorized as "very active, minimally active, and inactive." The Turkish version of the IPAQ-SF has been reported to be valid and reliable.'}, {'measure': 'Physical Activity Barriers', 'timeFrame': 'Baseline', 'description': 'Physical activity barriers will be assessed using the Self-Perceived Barriers for Physical Activity Questionnaire. This scale is a 17-item self-report scale that evaluates perceived barriers to participation in physical activity across four subscales: Body Image and Psychosocial Anxiety (5 items); Fatigue (3 items); Obligations and Lack of Time (3 items); and Environment and Availability (4 items). Scoring is done using a Likert scale ranging from 0 to 10 (0: Less - 10: More). Each subscale score is calculated by summing the scores of each item in the subscale and dividing the total score by the number of items. Higher scores indicate higher levels of barriers.'}, {'measure': 'Exercise Behavior Status', 'timeFrame': 'baseline', 'description': 'Exercise behavior will be assessed using the Stages of Exercise Behavior Change Questionnaire. This scale consists of 5 questions. Participants will be asked to choose one of 5 situations that correspond to their current exercise level, and the change stage is determined accordingly. The individual in the precontemplation stage has never considered starting to perform exercise and does not intend to do so in the next 6 months. The individual in the contemplation stage is not actively trying to start, but only intends to start in the next 6 months. The individual in the preparation stage intends to start exercising regularly within the next 30 days. The individual in the action stage begins to change their starting behavior within a short period of time (has been exercising for less than 6 months). The individual in the maintenance stage continues to maintain the change from the action stage, has been exercising for more than 6 months, and is determined not to revert to their old habit'}, {'measure': 'Physical Activity and Exercise-Related Experiences and Barriers Related to Lipedema', 'timeFrame': 'baseline', 'description': 'Women participating in the study will be asked about factors limiting physical activity related to lipedema, and their experiences during and after exercise or physical activity, and their personal statements will be recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lipedema', 'exercise', 'pain', 'sedentary behavior'], 'conditions': ['Lipedema']}, 'descriptionModule': {'briefSummary': "This study will be conducted with women diagnosed with lipedema who were referred to the Lymphedema Rehabilitation Unit of the Physiotherapy and Rehabilitation Department at Gazi University Faculty of Health Sciences for physiotherapy recommendations, and with healthy controls with similar characteristics. Demographic and clinical characteristics of individuals meeting the inclusion criteria and voluntarily agreeing to participate in the study will be recorded. Based on patient statements, factors limiting physical activity due to lipedema, and experiences during and after exercise will be recorded. Additionally, individuals' exercise behavior will be assessed using the Stages of Exercise Behavior Change Questionnaire, their physical activity level using the International Physical Activity Questionnaire-Short Form, and their physical activity barriers using the Self-Perceived Barriers for Physical Activity Questionnaire Data obtained from patient statements, scales, and questionnaires will be compared."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women living in Ankara, Türkiye, who have been diagnosed with lipedema', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* being between 18 and 65 years of age.\n\nExclusion Criteria:\n\n* having a diagnosis of cardiovascular, pulmonary, orthopedic, neurological, or cancer\n* having a body mass index \\>35 kg/m2\n* having undergone surgery that limited physical activity within the last 6 months.'}, 'identificationModule': {'nctId': 'NCT07458932', 'briefTitle': 'Evaluation of Physical Activity in Women With Lipedema', 'organization': {'class': 'OTHER', 'fullName': 'Gazi University'}, 'officialTitle': 'Exercise Behavior, Physical Activity, and Perceived Barriers in Women With Lipedema: A Case-Control Study', 'orgStudyIdInfo': {'id': '2025-2081'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lipedema Group', 'description': 'Women with lipedema diagnosis'}, {'label': 'Healthy control', 'description': 'Healthy women'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06490', 'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Miray Haspolat, PhD', 'role': 'CONTACT', 'email': 'miraybalaman@gmail.com', 'phone': '+90 542 792 2639'}], 'facility': 'Gazi University Faculty of Health Sciences', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Miray Haspolat, PhD', 'role': 'CONTACT', 'email': 'miraybalaman@gmail.com', 'phone': '+90 542 792 2639'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gazi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Ilke Keser', 'investigatorAffiliation': 'Gazi University'}}}}