Ignite Creation Date:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2026-01-02 @ 8:41 AM
Study NCT ID:
NCT06907004
Status:
COMPLETED
Last Update Posted:
2025-04-02
First Post:
2025-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Developing a Exercise Program for Patients Undergoing Hematopoietic Stem Cell Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-31', 'studyFirstSubmitDate': '2025-03-19', 'studyFirstSubmitQcDate': '2025-03-31', 'lastUpdatePostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exercise adherence rate', 'timeFrame': 'approximately 4-6 weeks', 'description': 'Definition: The percentage of prescribed exercise sessions completed by participants during the hematopoietic stem cell transplantation hospitalization period.\n\nMeasurement Method:\n\n1. Numerator: Number of completed exercise sessions\n2. Denominator: Total number of prescribed exercise sessions\n3. Unit of Measure: Percentage (%)'}, {'measure': 'Patient Satisfaction Score of the Exercise Program', 'timeFrame': 'approximately 4-6 weeks', 'description': "Definition: The mean score of a 7-item satisfaction questionnaire using a 5-point Likert scale to evaluate patient's satisfaction with the exercise program.\n\nMeasurement Method:\n\n1. Tool: 7-item satisfaction questionnaire with 5-point Likert scale Scale Range: 1 (strongly disagree) to 5 (strongly agree)\n2. Total Score Calculation: Mean score of all 7 items\n3. Unit of Measure: Score on a scale (1-5)\n\nQuestionnaire Items:\n\n1. Appropriateness of exercise timing\n2. Appropriateness of exercise intensity\n3. Appropriateness of exercise frequency\n4. Appropriateness of exercise type and difficulty level\n5. Achievement of exercise goals\n6. Satisfaction with personal performance\n7. Willingness to continue exercising"}, {'measure': 'Exercise-Related Adverse Events Rate', 'timeFrame': 'approximately 4-6 weeks', 'description': 'Definition: The percentage of exercise sessions with adverse events during the hematopoietic stem cell transplantation hospitalization period.\n\nMeasurement Method:\n\n1. Numerator: Number of exercise sessions with adverse events\n2. Denominator: Total number of completed exercise sessions\n3. Unit of Measure: Percentage (%)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Action research', 'Hematopoietic stem cell transplantation', 'Exercise program'], 'conditions': ['Hematopoietic Stem Cell Transplantation']}, 'referencesModule': {'references': [{'pmid': '32075567', 'type': 'BACKGROUND', 'citation': 'Morishita S, Nakano J, Fu JB, Tsuji T. Physical exercise is safe and feasible in thrombocytopenic patients with hematologic malignancies: a narrative review. Hematology. 2020 Dec;25(1):95-100. doi: 10.1080/16078454.2020.1730556.'}, {'pmid': '23252444', 'type': 'BACKGROUND', 'citation': 'Morishita S, Kaida K, Setogawa K, Kajihara K, Ishii S, Ikegame K, Kodama N, Ogawa H, Domen K. Safety and feasibility of physical therapy in cytopenic patients during allogeneic haematopoietic stem cell transplantation. Eur J Cancer Care (Engl). 2013 May;22(3):289-99. doi: 10.1111/ecc.12027. Epub 2012 Dec 18.'}, {'pmid': '30653940', 'type': 'BACKGROUND', 'citation': "Mohammed J, Aljurf M, Althumayri A, Almansour M, Alghamdi A, Hamidieh AA, ElHaddad A, Othman TB, Bazarbachi A, Almohareb F, Alzahrani M, Alkindi SS, Alsharif F, Da'na W, Alhashmi H, Bekadja MA, Al-Shammari SH, El Quessar A, Satti TM, Aljohani N, Rasheed W, Ghavamzadeh A, Chaudhri N, Hashmi SK. Physical therapy pathway and protocol for patients undergoing hematopoietic stem cell transplantation: Recommendations from The Eastern Mediterranean Blood and Marrow Transplantation (EMBMT) Group. Hematol Oncol Stem Cell Ther. 2019 Sep;12(3):127-132. doi: 10.1016/j.hemonc.2018.12.003. Epub 2019 Jan 11."}, {'pmid': '30277514', 'type': 'BACKGROUND', 'citation': 'Liang Y, Zhou M, Wang F, Wu Z. Exercise for physical fitness, fatigue and quality of life of patients undergoing hematopoietic stem cell transplantation: a meta-analysis of randomized controlled trials. Jpn J Clin Oncol. 2018 Dec 1;48(12):1046-1057. doi: 10.1093/jjco/hyy144.'}, {'pmid': '21132025', 'type': 'BACKGROUND', 'citation': 'Knols RH, de Bruin ED, Uebelhart D, Aufdemkampe G, Schanz U, Stenner-Liewen F, Hitz F, Taverna C, Aaronson NK. Effects of an outpatient physical exercise program on hematopoietic stem-cell transplantation recipients: a randomized clinical trial. Bone Marrow Transplant. 2011 Sep;46(9):1245-55. doi: 10.1038/bmt.2010.288. Epub 2010 Dec 6.'}, {'pmid': '31626055', 'type': 'BACKGROUND', 'citation': 'Campbell KL, Winters-Stone KM, Wiskemann J, May AM, Schwartz AL, Courneya KS, Zucker DS, Matthews CE, Ligibel JA, Gerber LH, Morris GS, Patel AV, Hue TF, Perna FM, Schmitz KH. Exercise Guidelines for Cancer Survivors: Consensus Statement from International Multidisciplinary Roundtable. Med Sci Sports Exerc. 2019 Nov;51(11):2375-2390. doi: 10.1249/MSS.0000000000002116.'}], 'seeAlsoLinks': [{'url': 'https://www.hpa.gov.tw/Pages/EBook.aspx?nodeid=1411', 'label': 'Physical Activity Guidelines for Taiwanese'}]}, 'descriptionModule': {'briefSummary': "Background: Hematopoietic stem cell transplantation (HSCT) is a highly aggressive treatment, which is associated with numerous treatment-related side effects, such as fatigue and decreased functional activity. While recent studies have shown that physical exercise for patients undergoing HSCT is safe and feasible, and has a positive effect on the quality of life, fatigue, and lower limb muscle strength. However, there is no consensus regarding the intensity, type and frequency of exercise program, and few studies mention the patients' experience of exercise barriers and facilitators during HSCT. Therefore, the clinical implementation of exercise program is quite difficult.\n\nPurpose: The purpose of this study is to develop a feasible exercise program for hospitalized patients undergoing hematopoietic stem cell transplantation.\n\nMethods: Action Research is used to collect quantitative and qualitative data. Through the rolling revision of the exercise program during HSCT, finally develop a feasible exercise program.\n\nExpected results: Developing a feasible exercise program for hospitalized patients undergoing hematopoietic stem cell transplantation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'genderBased': False, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'First-time hematopoietic stem cell transplantation (HSCT) patients and their primary caregivers, and physical therapists and nurses at Chimei Medical Center.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. First-time hematopoietic stem cell transplantation (HSCT) patients who are ambulatory, their primary caregivers, and physical therapists and nurses participating in the exercise intervention;\n2. Age 20 years or older;\n3. Capable of understanding and complying with the study objectives;\n4. No psychiatric disorders or cognitive impairments.\n\nExclusion Criteria:\n\n1. HSCT patients deemed unsuitable for exercise participation based on the attending physician's assessment;\n2. HSCT patients at risk of fractures or confined to bed rest due to musculoskeletal conditions."}, 'identificationModule': {'nctId': 'NCT06907004', 'briefTitle': 'Developing a Exercise Program for Patients Undergoing Hematopoietic Stem Cell Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Chimei Medical Center'}, 'officialTitle': 'Developing a Exercise Program for Patients Undergoing Hematopoietic Stem Cell Transplantation: An Action Research Approach.', 'orgStudyIdInfo': {'id': '11111-006'}}, 'contactsLocationsModule': {'locations': [{'zip': '71004', 'city': 'Tainan', 'state': 'Taiwan', 'country': 'Taiwan', 'facility': 'Chimei Medical Center', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}], 'overallOfficials': [{'name': "Min-Syuan Yen, Master's Degree", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chimei Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Individual participant data (IPD) will not be shared due to the following reasons:\n\n1. Privacy and confidentiality concerns - The study involves sensitive medical information from HSCT patients and personal experiences from healthcare providers.\n2. Ethical restrictions - The informed consent obtained from participants did not include permission for data sharing beyond the research team.\n3. Hospital policy compliance - The participating medical center's regulations restrict the sharing of patient-related data to protect patient privacy.\n4. Small sample size - With only 24 participants, sharing individual data might risk participant identification, even if anonymized."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chimei Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}