Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT04300335
Status:
SUSPENDED
Last Update Posted:
2025-10-01
First Post:
2020-03-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Feasibility and Effects of Exercise on Patients Suffering From Multiple Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Group 1: Individual exercise prescription (high fracture risk and/or high risk of fall patients) Group 2: Group exercise (low fracture risk and low risk of fall patients)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'whyStopped': 'The study was not started because the necessary resources could not yet be secured after COVID-19, which was the reason for the initial interruption of the study.', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-25', 'studyFirstSubmitDate': '2020-03-02', 'studyFirstSubmitQcDate': '2020-03-05', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Basic Module (EORTC QLQ-C30)', 'timeFrame': 'Baseline + 12 weeks', 'description': 'Cancer specific quality of life (Questionnaire); Score range from 0 to 100; A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.'}, {'measure': 'European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Myeloma Module (EORTC QLQ-MY20)', 'timeFrame': 'Baseline + 12 weeks', 'description': 'Multiple myeloma specific quality of life (Questionnaire); Score range from 0 to 100; A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.'}, {'measure': 'European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Fatigue Module (EORTC QLQ-FA12)', 'timeFrame': 'Baseline + 12 weeks', 'description': 'Cancer related fatigue specific quality of life (Questionnaire); Score range from 0 to 100; A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.'}, {'measure': 'European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Sexual Health Quality Module (EORTC QLQ-SHQ22)', 'timeFrame': 'Baseline + 12 weeks', 'description': 'Cancer related sexual health specific quality of life (Questionnaire); Score range from 0 to 100; A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.'}, {'measure': 'International Physical Activity Questionnaire (IPAQ)', 'timeFrame': 'Baseline + 12 weeks', 'description': 'Physical Activity (Questionnaire); Patients are asked about the frequency and volume of at least 10 minutes long episodes of vigorous and moderate physical activity during their last 7 days.\n\nHigher values indicate higher levels of physical activity.'}, {'measure': 'Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': 'Baseline + 12 weeks', 'description': 'Anxiety and Depression (Questionnaire); Score range from 0-21; lower scores indicating lower levels anxiety and depression'}, {'measure': 'Work Ability Index (WAI)', 'timeFrame': 'Baseline + 12 weeks', 'description': 'Work Ability (Questionnaire); Score range 1-10; higher scores indicating higher work ability'}, {'measure': 'Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': 'Baseline + 12 weeks', 'description': 'Sleep Quality (Questionnaire); score range from 0 to 21; lower scores indicating healthier sleep quality'}, {'measure': 'Falls Efficacy Scale (FES)', 'timeFrame': 'Baseline + 12 weeks', 'description': 'Fall Risk Assessment (Questionnaire); score range from 16 to 64; higher values indicate less fall-related self-efficacy (and more concern about falling).'}], 'primaryOutcomes': [{'measure': 'Feasibility (Adherence)', 'timeFrame': 'Adherence rates through 12 weeks of exercise intervention program', 'description': 'We hypothesize that the adherence of "High Risk Patients" to a personal, individualized exercise intervention is equal to that of "Low Risk Patients" performing group exercise.'}], 'secondaryOutcomes': [{'measure': 'VO2max', 'timeFrame': 'Baseline + 12 weeks', 'description': 'Maximum oxygen consumption in a cardiopulmonary exercise testing'}, {'measure': 'Handgrip Strength (HGS)', 'timeFrame': 'Baseline + 12 weeks', 'description': 'Handgrip Dynamometer (JAMAR)'}, {'measure': 'Six Minute Walk Test (6MWT)', 'timeFrame': 'Baseline + 12 weeks', 'description': 'Distance covered when walking as fast as possible in six minutes'}, {'measure': 'Tinetti-Test/Performance Oriented Mobility Assessment (POMA)', 'timeFrame': 'Baseline + 12 weeks', 'description': 'Risk of Fall Assessment'}, {'measure': 'Timed up and Go Test (TUG)', 'timeFrame': 'Baseline + 12 weeks', 'description': 'Risk of Fall Assessment'}, {'measure': 'Bioimpedance Analysis (BiA)', 'timeFrame': 'Baseline + 12 weeks', 'description': 'Body Composition measurement measured with Nutribox (BiA)'}, {'measure': 'Five Repetitions Sit-to-Stand Test (5STS)', 'timeFrame': 'Baseline + 12 weeks', 'description': 'Test for Lower Extremity Strength (time needed to stand up and sit down on a chair 5 times)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['exercise', 'fracture risk'], 'conditions': ['Multiple Myeloma']}, 'referencesModule': {'references': [{'pmid': '30539278', 'type': 'BACKGROUND', 'citation': 'Radocha J, Hajek R, Brozova L, Pour L, Spicka I, Minarik J, Gregora E, Jungova A, Jelinek T, Heindorfer A, Sykora M, Maisnar V. Simplified novel prognostic score for real-life older adults with multiple myeloma-registry-based analysis. Ann Hematol. 2019 Apr;98(4):951-962. doi: 10.1007/s00277-018-3568-2. Epub 2018 Dec 11.'}, {'pmid': '23569317', 'type': 'BACKGROUND', 'citation': 'Warren JL, Harlan LC, Stevens J, Little RF, Abel GA. Multiple myeloma treatment transformed: a population-based study of changes in initial management approaches in the United States. J Clin Oncol. 2013 Jun 1;31(16):1984-9. doi: 10.1200/JCO.2012.46.3323. Epub 2013 Apr 8.'}, {'pmid': '24157580', 'type': 'BACKGROUND', 'citation': 'Kumar SK, Dispenzieri A, Lacy MQ, Gertz MA, Buadi FK, Pandey S, Kapoor P, Dingli D, Hayman SR, Leung N, Lust J, McCurdy A, Russell SJ, Zeldenrust SR, Kyle RA, Rajkumar SV. Continued improvement in survival in multiple myeloma: changes in early mortality and outcomes in older patients. Leukemia. 2014 May;28(5):1122-8. doi: 10.1038/leu.2013.313. Epub 2013 Oct 25.'}, {'pmid': '11879296', 'type': 'BACKGROUND', 'citation': 'Mock V, Pickett M, Ropka ME, Muscari Lin E, Stewart KJ, Rhodes VA, McDaniel R, Grimm PM, Krumm S, McCorkle R. Fatigue and quality of life outcomes of exercise during cancer treatment. Cancer Pract. 2001 May-Jun;9(3):119-27. doi: 10.1046/j.1523-5394.2001.009003119.x.'}, {'pmid': '30686037', 'type': 'BACKGROUND', 'citation': 'Crevenna R. Aspects of cancer rehabilitation: an Austrian perspective. Disabil Rehabil. 2020 Jan;42(1):1. doi: 10.1080/09638288.2018.1522554. Epub 2019 Jan 27. No abstract available.'}, {'pmid': '26441078', 'type': 'BACKGROUND', 'citation': 'Crevenna R. Cancer rehabilitation and palliative care--two important parts of comprehensive cancer care. Support Care Cancer. 2015 Dec;23(12):3407-8. doi: 10.1007/s00520-015-2977-1. Epub 2015 Oct 6. No abstract available.'}, {'pmid': '20559064', 'type': 'BACKGROUND', 'citation': 'Schmitz KH, Courneya KS, Matthews C, Demark-Wahnefried W, Galvao DA, Pinto BM, Irwin ML, Wolin KY, Segal RJ, Lucia A, Schneider CM, von Gruenigen VE, Schwartz AL; American College of Sports Medicine. American College of Sports Medicine roundtable on exercise guidelines for cancer survivors. Med Sci Sports Exerc. 2010 Jul;42(7):1409-26. doi: 10.1249/MSS.0b013e3181e0c112.'}, {'pmid': '31784826', 'type': 'BACKGROUND', 'citation': 'Cenik F, Keilani M, Hasenohrl T, Huber D, Stuhlpfarrer B, Pataraia A, Crevenna R. Relevant parameters for recommendations of physical activity in patients suffering from multiple myeloma : A pilot study. Wien Klin Wochenschr. 2020 Mar;132(5-6):124-131. doi: 10.1007/s00508-019-01582-z. Epub 2019 Nov 29.'}], 'seeAlsoLinks': [{'url': 'https://www.statistik.at/web_de/statistiken/menschen_und_gesellschaft/gesundheit/krebserkrankungen/plasmozytom_myelom/index.html', 'label': 'Austrian Cancer Statistics Plasmocytoma/Myeloma'}]}, 'descriptionModule': {'briefSummary': 'Multiple myeloma is the second most common haematological cancer with a cancer incidence of around 500 new cases in Austria per year . Novel treatment methods have significantly increased the cancer-specific survival rate in patients with multiple myeloma. For Austria, this means that 5- and 10-year survival rates rose from 32.1 to 46.4% and from 19.0 to 25.6% from the end of the 1980s to the end of the 2000s.\n\nLonger survival is associated with the need to maintain independence and quality of life in the longer term. In this context, regular physical training has seen a significant increase in the importance of cancer in recent years.The guidelines of the American College of Sports Medicine still contain very general training recommendations for cancer patients. Either 150 minutes of moderate or 75 minutes of intensive endurance training per week are recommended, supplemented by at least two units of strengthening training and stretching exercises for the large muscle groups.\n\nIn a recent cross-sectional and pilot study with multiple myeloma patients that was carried out at the Clinic for Physical Medicine, Rehabilitation and Occupational Medicine at the Medical University of Vienna (EK 1725/2018), it was on the one hand identified that there was a discrepancy between these patients on the one hand has given actual and perceived risk of falling, and on the other hand it is concluded that training recommendations should be carried out separately in group and individual training according to the actual risk of falling and fracture.\n\nThe present project is the follow-up to this cross-sectional investigation. The aim is to examine the feasibility and effects of a structured, physical training program carried out over a period of 12 weeks on physical performance, quality of life, body composition and the risk of falling. The effects of patients with increased risk in individual training sessions are compared to those of lower risk patients in group training sessions. Furthermore, the study patients will be able to bring training partners with them to their own training units if available and for their own security. They are evaluated separately according to qualitative criteria.', 'detailedDescription': 'The aim of this study is to investigate the feasibility and effectiveness of individualized training support for multiple myeloma patient populations divided into high and low risk according to their fall and fracture risk. The primary hypothesis is that multiple myeloma patients who meet the criteria for a high risk of falling and / or fracture can achieve equivalent adherence rates and training effects through individually compiled individual training, such as multiple myeloma patients with low risk of falling who conduct group training.\n\nThe adherence rates are recorded via attendance lists for training and video conferences as well as a training diary for independent training. To record the training effects, physical performance and functionality are measured and the quality of life, sexuality, depression, fatigue, sleep quality, work ability and risk of falling are assessed using standardized, validated questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Multiple Myeloma after primary Treatment\n* Sufficient knowledge of the German language to being able to follow the study procedures\n* Cardiologic-internal clearance for exercise\n\nExclusion Criteria:\n\n* Fulfillment of absolute exclusion criteria of the cardiovascular system or on the musculoskeletal system with regard to physical trainability\n* Insufficient language knowledge\n* Cognitively unable to follow the course of the study\n* Severe mental illness'}, 'identificationModule': {'nctId': 'NCT04300335', 'briefTitle': 'The Feasibility and Effects of Exercise on Patients Suffering From Multiple Myeloma', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'The Feasibility and Effects of an Individualized Aerobic and Resistance Training Protocol for Patients Suffering From Multiple Myeloma With Varying Risk of Fall and Fracture - a Pilot Study', 'orgStudyIdInfo': {'id': '2172/2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High Risk - Individual Exercise', 'description': 'Patients who show an increased fracture risk and/or increased risk of fall in the screening assessments and are therefore allocated to an individualized personal training.', 'interventionNames': ['Other: Individual Exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Low Risk - Group Exercise', 'description': 'Patients who show neither increased fracture risk nor increased risk of fall in the screening assessments and are therefore allocated to the exercise group.', 'interventionNames': ['Other: Group Exercise']}], 'interventions': [{'name': 'Individual Exercise', 'type': 'OTHER', 'description': 'Supervised body weight \\& resistance band resistance exercises in a one-on-one personal training setting plus home based aerobic exercise', 'armGroupLabels': ['High Risk - Individual Exercise']}, {'name': 'Group Exercise', 'type': 'OTHER', 'description': 'Supervised body weight \\& resistance band resistance exercises in a Group setting plus home based aerobic exercise', 'armGroupLabels': ['Low Risk - Group Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Richard Crevenna, Prof. MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Univ.-Prof. Dr. Richard Crevenna, MBA, MMSc, Head of the Department of Physical Medicine, Rehabilitation and Occupational Medicine', 'investigatorFullName': 'Richard Crevenna', 'investigatorAffiliation': 'Medical University of Vienna'}}}}