Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:26 AM
Study NCT ID:
NCT07044427
Status:
RECRUITING
Last Update Posted:
2025-07-01
First Post:
2025-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fall Risk Assessment and an Exercise Intervention for Prevention of Falls in Multiple Myeloma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-25', 'studyFirstSubmitDate': '2025-06-10', 'studyFirstSubmitQcDate': '2025-06-25', 'lastUpdatePostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of at least 48 out of 72 training sessions with the focus on fall prevention within 24 weeks', 'timeFrame': 'From enrollement to the end of the training intervention at 6 months', 'description': 'Patients will document the number of training sessions via an online training-app (Physiotec, Bad Wünnenberg, Germany). Feasibility is achieved if 48 of 72 possible training sessions were successfully completed.'}, {'measure': 'Effectivity (fear of falling)', 'timeFrame': 'Evaluated at the beginning of the study and at the end of the study after 6 months', 'description': 'Fear of falling will be evaluated by a validated questionnaire (FES-I, Falls Efficacy Scale-Inernational). The questionnaire contains 16 items scored on a four-point scale (1=not at all concerned to 4=very concerned). Scores \\>23 indicate high concern about falling.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multiple Myeloma', 'Fall risk', 'pertubation training', 'strength training', 'Balance'], 'conditions': ['Multiple Myeloma', 'Fall Risk Factors', 'Strength Training Effects', 'Balance Training Effects']}, 'referencesModule': {'references': [{'pmid': '29239009', 'type': 'BACKGROUND', 'citation': 'Wildes TM, Fiala MA. Falls in older adults with multiple myeloma. Eur J Haematol. 2018 Mar;100(3):273-278. doi: 10.1111/ejh.13009. Epub 2018 Jan 8.'}, {'pmid': '25454770', 'type': 'BACKGROUND', 'citation': 'Wildes TM, Dua P, Fowler SA, Miller JP, Carpenter CR, Avidan MS, Stark S. Systematic review of falls in older adults with cancer. J Geriatr Oncol. 2015 Jan;6(1):70-83. doi: 10.1016/j.jgo.2014.10.003. Epub 2014 Oct 30.'}, {'pmid': '37727991', 'type': 'BACKGROUND', 'citation': 'Dapunt U, Ehret P, Paratte JL, Kuehl RM, Wiskemann J, Jager D, Muller-Tidow C, Raab MS, Goldschmidt H. A precision-based exercise program for patients with multiple myeloma. Eur J Haematol. 2023 Dec;111(6):930-937. doi: 10.1111/ejh.14106. Epub 2023 Sep 20.'}, {'pmid': '27450557', 'type': 'BACKGROUND', 'citation': 'Sattar S, Alibhai SM, Spoelstra SL, Fazelzad R, Puts MT. Falls in older adults with cancer: a systematic review of prevalence, injurious falls, and impact on cancer treatment. Support Care Cancer. 2016 Oct;24(10):4459-69. doi: 10.1007/s00520-016-3342-8. Epub 2016 Jul 22.'}, {'pmid': '26907564', 'type': 'BACKGROUND', 'citation': 'Pandya C, Magnuson A, Dale W, Lowenstein L, Fung C, Mohile SG. Association of falls with health-related quality of life (HRQOL) in older cancer survivors: A population based study. J Geriatr Oncol. 2016 May;7(3):201-10. doi: 10.1016/j.jgo.2016.01.007. Epub 2016 Feb 18.'}]}, 'descriptionModule': {'briefSummary': 'Approximatly one third of the population over the age of 65 fall at least once a year. The risk of falling is in increased in older patients with tumor diseases. In addition to high treatment and care costs for the healthcare system, falls often lead to a decrease of quality of life, a reduction in physical performance and a loss of independence. Despite the high risk, falls in cancer patients have not yet been scientifically investigated in detail. For patients with multiple myeloma in particular, very little data is available on the prevalence, risk factors and effects of falls. In this study, a fall risk assessment is carried out in patients with multiple myeloma. Furthermore, a patient-specific training intervention for fall prevention will be carried out.\n\nThe aim of the study is to identify possible fall risk factors in multiple myeloma patients and to establish a structured exercise intervention that minimizes the risk of falls and injuries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with multiple myeloma requiring therapy (at least 6 months of systemic therapy)\n* ECOG status ≤ 3\n* Age ≥18 years\n* Patients who state that they want to carry out the training program at least 3 times/week and participate in the planned follow-up visits\n* Ability to give informed consent\n* Written consent to participate in the study\n* Sufficient written and spoken German to complete the questionnaire\n\nExclusion Criteria:\n\n* Any physical or mental limitations that would prevent participation in the training program or the planned follow-up checks.'}, 'identificationModule': {'nctId': 'NCT07044427', 'acronym': 'Myfall', 'briefTitle': 'Fall Risk Assessment and an Exercise Intervention for Prevention of Falls in Multiple Myeloma Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Heidelberg'}, 'officialTitle': 'Investigation of Fall Risk Factors and Implementation of an Exercise Intervention for Prevention of Falls in Patients With Multiple Myeloma', 'orgStudyIdInfo': {'id': 'S-045/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Exercise Intervention', 'description': 'Fall Prevention', 'interventionNames': ['Other: Strength and balance training in combination with a treadmill-based pertubation intervention']}], 'interventions': [{'name': 'Strength and balance training in combination with a treadmill-based pertubation intervention', 'type': 'OTHER', 'description': 'Patients receive a personalized home-based training plan with strength and balance exercises to be carried out three times a week for six months. In addition, treadmill-based pertubation training is carried out at 2 timepoints.', 'armGroupLabels': ['Exercise Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'state': 'Baden Würtemberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Ulrike Dapunt, Prof. Dr. med', 'role': 'CONTACT', 'email': 'ulrike.dapunt@med.uni-heidelberg.de', 'phone': '+49 622156 32765'}], 'facility': 'University Hospital Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'centralContacts': [{'name': 'Ulrike Dapunt, prof. Dr. med', 'role': 'CONTACT', 'email': 'ulrike.dapunt@med.uni-heidelberg.de', 'phone': '+49 622156 32765'}], 'overallOfficials': [{'name': 'Dapunt', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital Heidelberg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': '* questionnaire results collected for each individual\n* functional test results collected for each individual'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Heidelberg', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bethanien Krankenhaus gGmbH', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med.', 'investigatorFullName': 'Ulrike Dapunt', 'investigatorAffiliation': 'University Hospital Heidelberg'}}}}