Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2026-02-22 @ 7:04 AM
Study NCT ID:
NCT06521268
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-03
First Post:
2024-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Inspiratory Muscle Training on Lymphedema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008209', 'term': 'Lymphedema'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized controlled study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-05-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-01', 'studyFirstSubmitDate': '2024-07-16', 'studyFirstSubmitQcDate': '2024-07-24', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Volumetric Measurement', 'timeFrame': 'baseline and immediately after the intervention (in the 5th week)', 'description': 'to measure volume of the upper extremity in milliliter (increased volume compared to the normal upper extremity- increased score means worse outcome)'}, {'measure': 'Measurement of Subcutaneous Tissue Thickness with Ultrasound (US)', 'timeFrame': 'baseline and immediately after the intervention (in the 5th week)', 'description': 'to measure thickness of the tissue (increased thickness compared to the normal upper extremity- increased score means worse outcome)'}], 'secondaryOutcomes': [{'measure': 'VISUAL ANALOG SCALE-VAS', 'timeFrame': 'baseline and immediately after the intervention (in the 5th week)', 'description': 'to measure swelling feel, heaviness of edema, and tension of edema (min. score is 0- max.score is10: higher score means worse outcome)'}, {'measure': 'HAND DYNAMOMETER', 'timeFrame': 'baseline and immediately after the intervention (in the 5th week)', 'description': 'to measure hand grip (in Newton- higher score means better score)'}, {'measure': 'Quick Disabilities Of the Arm,Shoulder And Hand (Quick DASH)', 'timeFrame': 'baseline and immediately after the intervention (in the 5th week)', 'description': 'to measure physical functioning of upper extremities (min. scorre is 0-max.score is 100- higher score means worse outcome)'}, {'measure': 'Respiratory Function Test', 'timeFrame': 'before and after the intervention (in the 5th week)', 'description': 'to measure respiratory parameters (FEV1, FVC- higher score means better)'}, {'measure': 'Intraoral pressure measure', 'timeFrame': 'before and after the intervention (in the 5th week)', 'description': 'to measure Intraoral Pressure parameters (MEP and MIP- higher score means better)'}, {'measure': 'Lymphedema Life Impact Scale - LLIS', 'timeFrame': 'before and after the intervention (in the 5th week)', 'description': 'to measure impact of lymphedema on the survivors with lymphedema (min. score is 18 and max. score is 90- higher score means worse outcome)'}, {'measure': 'Lymph-ICF', 'timeFrame': 'before and after the intervention (in the 5th week)', 'description': 'to describe Lymphoedema Functioning, Disability And Health status of the partifcipants (min. score is 0 and max. score is 290- higher score means worse outcome)'}, {'measure': 'Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': 'before and after the intervention (in the 5th week)', 'description': 'to measure sleep quality (min. score is 0 and max.score is 21 - higher score means worse outcome)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lymphedema', 'Inspiratory muscle training', 'Decongestive treatment', 'Physical functioning', 'Sleep quality', 'Quality of life'], 'conditions': ['Lymphedema']}, 'referencesModule': {'references': [{'pmid': '24283509', 'type': 'RESULT', 'citation': 'Hacard F, Machet L, Caille A, Tauveron V, Georgescou G, Rapeneau I, Samimi M, Patat F, Vaillant L. Measurement of skin thickness and skin elasticity to evaluate the effectiveness of intensive decongestive treatment in patients with lymphoedema: a prospective study. Skin Res Technol. 2014 Aug;20(3):274-81. doi: 10.1111/srt.12116. Epub 2013 Nov 27.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to examine the effect of inspiratory muscle training on lymphedema volume, subcutaneous tissue thickness, upper extremity functionality and sleep quality in the treatment of upper extremity lymphedema. Two groups included 24 patients with lymphedema will be divided into gropus (intervetion and control) and they will compare each other.', 'detailedDescription': 'All patients will be treated 5 days a week, 4 weeks, with each session lasting 45-60 minutes. While only decongestive treatment will be applied to the control group, inspiratory muscle training will be given to the interventional group in addition to decongestive treatment. Evaluations of the patients will be made before and after of 4-week treatment program.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHaving been diagnosed with lymphedema in the upper extremity at least 6 months ago\n\n* Having stage 2 lymphedema\n* Having a 2-8 cm circumference difference between the affected extremity and the healthy extremity at any reference point\n* Being between the ages of 18-60\n* Voluntarily agreeing to participate in the study\n* Not having received any lymphedema treatment in the last 6 months.\n* Not having any physical, respiratory, neurological and/or systemic disease that would prevent participation in the treatment program.\n\nExclusion Criteria:\n\nHaving stage 1 and stage 3 lymphedema\n\n* It has been less than 6 months since the diagnosis of lymphedema was made\n* Being under 18 years of age and over 60 years of age\n* Having a circumference measurement difference of more than 8 cm and less than 2 cm at any reference point between the affected extremity and the healthy extremity\n* Lymphedema or elephantiasis with papilloma, hyperkeratosis\n* Uncontrolled hypertension, pulmonary edema, presence of serious cardiovascular disease\n* Presence of active metastasis\n* Acute inflammatory diseases'}, 'identificationModule': {'nctId': 'NCT06521268', 'briefTitle': 'Effects of Inspiratory Muscle Training on Lymphedema', 'organization': {'class': 'OTHER', 'fullName': 'Biruni University'}, 'officialTitle': 'Effects of Inspiratory Muscle Training on Lymphedema Volume, Subcutaneous Tissue Thickness, Upper Extremity Functioning, Sleep Quality, and Quality of Life in Upper Extremity Lymphedema Treatment: a Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'BiruniUnivers'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Inspiratory muscle training', 'interventionNames': ['Other: Inspiratory muscle training', 'Other: Decongestive treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'Controls', 'interventionNames': ['Other: Decongestive treatment']}], 'interventions': [{'name': 'Inspiratory muscle training', 'type': 'OTHER', 'otherNames': ['Muscle training'], 'description': 'Inspiratory muscle training', 'armGroupLabels': ['Group 1']}, {'name': 'Decongestive treatment', 'type': 'OTHER', 'description': 'Decongestive treatment', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34010', 'city': 'Istanbul', 'state': 'Zeytinburnu', 'country': 'Turkey (Türkiye)', 'facility': 'Faculty of Health Sciences in Biruni University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'UGUR CAVLAK, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Biruni University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biruni University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'CLINICAL PROFESSOR', 'investigatorFullName': 'Ugur Cavlak', 'investigatorAffiliation': 'Biruni University'}}}}