Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-04-05 @ 10:57 AM
Study NCT ID:
NCT07448467
Status:
RECRUITING
Last Update Posted:
2026-03-12
First Post:
2026-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of the Effectiveness of Progressive Resistance Exercise Training in the Management of Lymphedema.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008209', 'term': 'Lymphedema'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-10', 'studyFirstSubmitDate': '2026-02-26', 'studyFirstSubmitQcDate': '2026-02-26', 'lastUpdatePostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LYMphedema Quality of Life', 'timeFrame': '14 weeks', 'description': 'The Lymphedema Quality of Life Questionnaire, a validated disease-specific QoL tool, was also administered at baseline and at day 28. Overall QoL is scored on a single item by the patient on a scale of 1-10.'}, {'measure': 'Disabilities of the Arm, Shoulder and Hand', 'timeFrame': '14 weeks', 'description': 'Validated outcome measure that asks an individual to self-report about the ability to perform certain upper limb activities. Questions are responded on a 5-point Likert scale.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lymphedema', 'Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '41149475', 'type': 'BACKGROUND', 'citation': 'Leon-Diaz R, Medina-Otero A. Prevention and Treatment of Postmastectomy Lymphedema: A Physiotherapy Perspective. Curr Oncol. 2025 Oct 3;32(10):555. doi: 10.3390/curroncol32100555.'}, {'pmid': '40498485', 'type': 'BACKGROUND', 'citation': 'Shamsesfandabadi P, Shams Esfand Abadi M, Yin Y, Carpenter DJ, Peluso C, Hilton C, Coopey SB, Gomez J, Beriwal S, Champ CE. Resistance Training and Lymphedema in Breast Cancer Survivors. JAMA Netw Open. 2025 Jun 2;8(6):e2514765. doi: 10.1001/jamanetworkopen.2025.14765.'}, {'pmid': '40859515', 'type': 'BACKGROUND', 'citation': 'Xue T, Zhang L, Zhang D. Exercise-based interventions for postoperative rehabilitation in breast cancer patients: A systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2025 Aug 22;104(34):e43705. doi: 10.1097/MD.0000000000043705.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the effect of progressive resistance exercise training on the clinical findings and functional outcomes of lymphedema in individuals who develop upper extremity lymphedema after breast cancer treatment (surgery, chemotherapy and/or radiotherapy).', 'detailedDescription': 'The study is designed as a randomized controlled trial. Volunteers participating in the study will consist of individuals who have developed lymphedema after breast cancer and who agree to participate in the study. Volunteer female participants will be divided into 2 groups of equal numbers. Participants in the control group will receive lymphedema treatment, while participants in the exercise group will perform progressive resistance upper extremity exercises at home, 2 days a week for 12 weeks. All exercises will be performed with compression bandages. All participants will be evaluated before and after treatment using a hand dynamometer, the Disabilities of the Arm, Shoulder and Hand Scale, and the Lymphedema Quality of Life Questionnaire-Arm.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Being between 18 and 60 years of age.\n* Being included in the study 3 months after undergoing surgery.\n* Being able to tolerate compression bandages or compression garments.\n\nExclusion criteria:\n\n\\- Individuals who need to restart active cancer treatment during the study period. - Being within the first 3 months after surgery.'}, 'identificationModule': {'nctId': 'NCT07448467', 'briefTitle': 'Investigation of the Effectiveness of Progressive Resistance Exercise Training in the Management of Lymphedema.', 'organization': {'class': 'OTHER', 'fullName': 'Uskudar University'}, 'officialTitle': 'Investigating the Effectiveness of Progressive Resistance Exercise Training in the Management of Lymphedema Developing After Breast Cancer Treatment: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Uskudar96'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'They will receive classic lymphedema physiotherapy.', 'interventionNames': ['Other: control']}, {'type': 'EXPERIMENTAL', 'label': 'exercise group', 'description': 'In addition to classic lymphedema physiotherapy, a progressive resistance exercise training program will be implemented.', 'interventionNames': ['Other: control', 'Other: exercise']}], 'interventions': [{'name': 'control', 'type': 'OTHER', 'description': 'Classic lymphedema physiotherapy will be applied.', 'armGroupLabels': ['control group', 'exercise group']}, {'name': 'exercise', 'type': 'OTHER', 'description': 'In addition to classic lymphedema physiotherapy, a progressive resistance exercise training program will be implemented.', 'armGroupLabels': ['exercise group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Adana', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Sevinj RAFILI', 'role': 'CONTACT', 'phone': '+905411127284'}], 'facility': 'Re-Heal Physiotherapist Sude BOYVADAOĞLU Healthy Living Center', 'geoPoint': {'lat': 36.98615, 'lon': 35.32531}}], 'centralContacts': [{'name': 'Ömer ŞEVGİN', 'role': 'CONTACT', 'email': 'omer.sevgin@uskudar.edu.tr', 'phone': '+905069787535'}], 'overallOfficials': [{'name': 'Sevinj RAFILI', 'role': 'STUDY_CHAIR', 'affiliation': 'Uskudar University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uskudar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc.Prof.Dr.', 'investigatorFullName': 'Doç.Dr.Ömer Şevgin', 'investigatorAffiliation': 'Uskudar University'}}}}