Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 11:16 PM
Study NCT ID:
NCT05426993
Status:
COMPLETED
Last Update Posted:
2023-12-04
First Post:
2022-06-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Metabolic Syndrome on Complex Decongestive Physiotherapy Outcomes in Lymphedema Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008209', 'term': 'Lymphedema'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-01', 'studyFirstSubmitDate': '2022-06-16', 'studyFirstSubmitQcDate': '2022-06-16', 'lastUpdatePostDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Limb volume', 'timeFrame': '15.09.2022', 'description': 'Edema evaluation will be made for the lower extremity from the lateral malleolus to the groin at 4 cm intervals. For the upper extremity, it will be made from the styloid process of the ulna to the axilla at intervals of 4 cm. The extremity volume will be determined from the values obtained with the help of the Frustrum formula.'}], 'secondaryOutcomes': [{'measure': 'Life quality', 'timeFrame': '15.12.2022', 'description': 'Quality of life will be evaluated with the Lymphedema Quality of Life Scale used routinely. This assessment, which was validated by Borman et al., consists of 21 questions under the sub-titles of Function, Body Image, Symptom, and Emotion. Scoring between 1 and 4 is made for the first 20 questions. The total score for each area is calculated by adding all the scores and dividing by the total number of questions answered. High scores indicate lower quality of life. The last question about overall quality of life is scored from 0 to 10. Higher scores indicate better quality of life'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lymphedema', 'metabolic syndrome'], 'conditions': ['Lymphedema']}, 'referencesModule': {'references': [{'pmid': '38949715', 'type': 'DERIVED', 'citation': 'Pirincci CS, Mete O, Yasa ME, Dalyan M. A comparative evaluation of the efficacy of complete decongestive therapy in the treatment of unilateral breast cancer-related lymphedema with and without metabolic syndrome. Support Care Cancer. 2024 Jun 29;32(7):473. doi: 10.1007/s00520-024-08676-z.'}]}, 'descriptionModule': {'briefSummary': 'As a result of our research, investigators could not find any study investigating the effectiveness of complex decongestive physiotherapy (KBF) in lymphedema patients with metabolic syndrome. Therefore, our aim is to compare the effectiveness of KBF in patients with and without metabolic syndrome.', 'detailedDescription': 'This study was planned to investigate the effects of metabolic syndrome seen in patients with lymphedema on the results of complex decongestive physiotherapy. Lymphedema is a chronic disease characterized by the accumulation of protein-rich fluid in the interstitial space. Among all the treatment approaches known in the field, Complex Decongestive Physiotherapy (CDT) is accepted as the gold standard in the treatment of lymphedema. CDT is a treatment approach consisting of manual lymph drainage, skin care, compression bandage and exercises. In clinical studies conducted to date, the effectiveness of CDFT in the treatment of lower and upper extremity lymphedema has been clearly demonstrated.\n\nMetabolic syndrome is a medical term that describes the combination of various cardiovascular risk factors such as insulin resistance, impaired glucose tolerance or diabetes mellitus, obesity, abdominal fat accumulation, dyslipidemia, hypertension, and coronary artery disease. Obesity, the cardinal component of the metabolic syndrome, is a well-known risk factor for lymphedema, and increased body mass index (BMI) is associated with the frequency and severity of lymphedema. Obesity often accompanies lymphedema due to the effect of lymphedema and the characteristics of patients with lymphedema.\n\nOur aim in this study, which was planned in the light of these data, is to examine whether the presence of metabolic syndrome in patients with lymphedema changes the effectiveness of CDT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'As a result of the power analysis made with the help of the preliminary study data using the G\\*Power 3.0.10 program; with 90% power, 5% margin of error and f=0.27 effect size, a total of at least 40 samples were found to be sufficient (metabolic syndrome group: 20; control group: 20).\n\nPatients diagnosed with lymphedema by a specialist in our clinic will be divided into 2 groups as those with metabolic syndrome and those without metabolic syndrome.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Those between the ages of 18-65,\n* To be diagnosed with lymphedema in the lower or upper extremities\n* Volunteering to participate in the study\n* Getting \\>24 points from the Standardized Mini mental test\n\nExclusion Criteria:\n\n* Having a score of \\<24 on the Standardized Mini Mental Test\n* Finding any problem preventing communication'}, 'identificationModule': {'nctId': 'NCT05426993', 'briefTitle': 'Effect of Metabolic Syndrome on Complex Decongestive Physiotherapy Outcomes in Lymphedema Patients', 'organization': {'class': 'OTHER', 'fullName': 'Gulhane School of Medicine'}, 'officialTitle': 'Investigation of the Effects of Metabolic Syndrome on the Results of Complex Decongestive Physiotherapy in Lymphedema Patients', 'orgStudyIdInfo': {'id': 'E2-22-1805'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients diagnosed with lymphedema with metabolic syndrome', 'description': 'Demographic information of the patients (age, height, weight, occupation, history), comorbid diseases (hypertension, diabetes, cardiac problems, circulatory problems, thyroid dysfunction), operation date, operation type, affected extremity, type of lymphedema will be recorded. In addition to these, mental status, edema and quality of life assessments will also be made.\n\nAs a treatment, extremity volume and quality of life evaluations will be made before and after the first phase of CDT (manual lymphatic drainage, skin care, compression therapy and exercises) for 3 weeks.', 'interventionNames': ['Other: Complex decongestive physiotherapy']}, {'label': 'Patients diagnosed with lymphedema without metabolic syndrome', 'description': 'Demographic information of the patients (age, height, weight, occupation, history), comorbid diseases (hypertension, diabetes, cardiac problems, circulatory problems, thyroid dysfunction), operation date, operation type, affected extremity, type of lymphedema will be recorded. In addition to these, mental status, edema and quality of life assessments will also be made.\n\nAs a treatment, extremity volume and quality of life evaluations will be made before and after the first phase of CDT (manual lymphatic drainage, skin care, compression therapy and exercises) for 3 weeks.', 'interventionNames': ['Other: Complex decongestive physiotherapy']}], 'interventions': [{'name': 'Complex decongestive physiotherapy', 'type': 'OTHER', 'description': 'CDT is a treatment approach consisting of manual lymph drainage, skin care, compression bandage and exercises.', 'armGroupLabels': ['Patients diagnosed with lymphedema with metabolic syndrome', 'Patients diagnosed with lymphedema without metabolic syndrome']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'University of Health Sciences', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gulhane School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assocc. Prof.', 'investigatorFullName': 'Mustafa Ertuğrul Yaşa', 'investigatorAffiliation': 'Gulhane School of Medicine'}}}}