[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07616921":3,"trial-entities:NCT07616921":165,"trial-summary:NCT07616921":168},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":62,"secondary_outcomes":83,"sex":112,"minimum_age":113,"maximum_age":114,"healthy_volunteers":15,"eligibility_criteria":115,"std_ages":138,"locations":141,"central_contacts":159,"overall_officials":161,"references":163,"see_also_links":164},"NCT07616921","RG1125934","A Home-Based Exercise Intervention (CAREFit-BMT) in Improving Heart Function Among Patients With High Risk Acute Myeloid Leukemia Undergoing Stem Cell Transplant","CAREFit-BMT Program to Improve Cardiac Reserve in High-Risk Acute Myeloid Leukemia Patients Preparing to Undergo Allogeneic Hematopoietic Stem Cell Transplantation","NOT_YET_RECRUITING","2028-04-03","2026-05","2026-07-13","2026-10-01","University of Washington","OTHER",false,"This clinical trial studies how well a home-based exercise intervention called Cardiorespiratory Fitness in Bone Marrow Transplant Program (CAREFit-BMT) works in improving heart function among patients with high risk acute myeloid leukemia (AML) undergoing stem cell transplant. Older adults and those with other medical conditions are at a higher risk for complications in the heart and blood vessels (cardiovascular). Older age at transplantation has been associated with nearly all cardiovascular complications occurring after stem cell transplant. This is likely explained by the structural and functional changes that occur in aging hearts as well as the larger burden of cardiovascular risk factors such as diabetes, high blood pressure, and obesity. CAREFit-BMT is a \"prehabilitation\" program, or exercise initiated prior to intensive therapy, that consists of aerobic exercises and strength training. CAREFit-BMT may be able to increase the likelihood of safe and successful transition to stem cell transplant in patients with high risk AML.","OUTLINE:\n\nPatients undergo at-home moderate-intensity aerobic exercises over 30 minutes, 5 days per week, as well as strength training over 15-30 minutes, 3 days per week for up to 12 weeks in the absence of unacceptable toxicity. Patients also undergo blood sample collection throughout the study.\n\nAfter completion of the study intervention, patients are followed for 12 months.",[19],"Acute Myeloid Leukemia",[],"INTERVENTIONAL","SUPPORTIVE_CARE",[24],"NA",{"count":26,"type":27},30,"ESTIMATED",[29,36,42,52,56,59],{"type":14,"name":30,"description":31,"armGroupLabels":32,"otherNames":34},"Aerobic Exercise","Undergo moderate-intensity aerobic exercises",[33],"Supportive Care (CAREFit-BMT exercise program)",[35],"Aerobic Activity",{"type":14,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Resistance Training","Undergo strength training",[33],[41],"Strength Training",{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"PROCEDURE","Biospecimen Collection","Undergo collection of blood",[33],[48,49,50,51],"Biological Sample Collection","Biospecimen Collected","Sample Collection","Specimen Collection",{"type":14,"name":53,"description":54,"armGroupLabels":55},"Electronic Health Record Review","Ancillary studies",[33],{"type":14,"name":57,"description":54,"armGroupLabels":58},"Survey Administration",[33],{"type":14,"name":60,"description":54,"armGroupLabels":61},"Interview",[33],[63,67,70,74,77,80],{"measure":64,"description":65,"timeFrame":66},"Recruitment rates (Feasibility)","Recruitment will be calculated as the proportion of eligible patients who provide informed consent, with 95% confidence intervals, and reasons for ineligibility or refusal summarized from screening logs.","Up to 24 months",{"measure":68,"description":69,"timeFrame":66},"Retention rates (Feasibility)","Retention will be defined as the proportion of enrolled participants who complete the post-intervention assessment, also with 95% confidence intervals.",{"measure":71,"description":72,"timeFrame":73},"Adherence to program (Feasibility)","Adherence will be evaluated from both aerobic and resistance training participation, including the percentage of prescribed sessions completed and average weekly minutes of moderate-intensity aerobic activity from wearable device data.","At the end of the CAREFit-BMT program (Day 85)",{"measure":75,"description":76,"timeFrame":73},"Overall satisfaction (Feasibility): Acceptability of Intervention Measure mean score","Acceptability will be assessed using validated instrument, Acceptability of Intervention Measure, summarized as means with standard deviations. Scores range from 1 to 5, with higher scores indicating greater acceptability.",{"measure":78,"description":79,"timeFrame":73},"Overall satisfaction (Feasibility): Intervention Appropriateness Measure mean score","Will be assessed using validated instrument, Intervention Appropriateness Measure, summarized as means with standard deviations. Scores range from 1 to 5, with higher scores indicating greater appropriateness.",{"measure":81,"description":82,"timeFrame":73},"Overall satisfaction (Feasibility): Feasibility of Intervention Measure mean score","Will be assessed using validated instrument, Feasibility of Intervention Measure, summarized as means with standard deviations. Scores range from 1 to 5, with higher scores indicating greater feasibility.",[84,87,91,94,97,100,103,106,109],{"measure":85,"description":86,"timeFrame":73},"Barriers and facilitators of Cardiorespiratory Fitness in Bone Marrow Transplant Program (CAREFit-BMT)","Participant-specific barriers and facilitators to enrollment, participation, and adherence, will be assessed through semi-structured qualitative interviews informed by the Capability, Opportunity, Motivation, and Behavior (COM-B) framework.",{"measure":88,"description":89,"timeFrame":90},"Changes in cardiorespiratory fitness (CRF): Mean change in Anaerobic threshold","Will be measured by cardiopulmonary exercise testing to assess anaerobic threshold.\n\nWithin-participant change will be summarized as mean paired differences with two-sided 95% confidence intervals, standard deviations, and standardized mean changes. If distributions are notably non-normal (e.g. biomarkers), non-parametric paired methods will be used.","Baseline up to the end of the CAREFit-BMT program (Day 85)",{"measure":92,"description":93,"timeFrame":90},"Changes in cardiorespiratory fitness (CRF): Mean change in Peak oxygen consumption (VO₂peak)","Will be measured by cardiopulmonary exercise testing to assess peak oxygen consumption (VO₂peak).\n\nWithin-participant change will be summarized as mean paired differences with two-sided 95% confidence intervals, standard deviations, and standardized mean changes. If distributions are notably non-normal (e.g. biomarkers), non-parametric paired methods will be used.",{"measure":95,"description":96,"timeFrame":90},"Changes in cardiorespiratory fitness (CRF): Mean change in VO₂peak percent-predicted","Will be measured by cardiopulmonary exercise testing to assess VO₂peak percent-predicted.\n\nWithin-participant change will be summarized as mean paired differences with two-sided 95% confidence intervals, standard deviations, and standardized mean changes. If distributions are notably non-normal (e.g. biomarkers), non-parametric paired methods will be used.",{"measure":98,"description":99,"timeFrame":90},"Changes in cardiorespiratory fitness (CRF): Mean change in Respiratory exchange ratio at peak","Will be measured by cardiopulmonary exercise testing to assess respiratory exchange ratio at peak.\n\nWithin-participant change will be summarized as mean paired differences with two-sided 95% confidence intervals, standard deviations, and standardized mean changes. If distributions are notably non-normal (e.g. biomarkers), non-parametric paired methods will be used.",{"measure":101,"description":102,"timeFrame":90},"Changes in cardiorespiratory fitness (CRF): Mean change in Minute ventilation\u002Fcarbon dioxide production (VE\u002FVCO₂) slope","Will be measured by cardiopulmonary exercise testing to assess minute ventilation\u002Fcarbon dioxide production (VE\u002FVCO₂) slope.\n\nWithin-participant change will be summarized as mean paired differences with two-sided 95% confidence intervals, standard deviations, and standardized mean changes. If distributions are notably non-normal (e.g. biomarkers), non-parametric paired methods will be used.",{"measure":104,"description":105,"timeFrame":90},"Changes in cardiovascular (CV) symptoms","Will be measured using the Kansas City Cardiomyopathy Questionnaire-12. Standardized scores range from 0-100, with higher scores indicating better outcome.",{"measure":107,"description":108,"timeFrame":90},"Changes in CV biomarkers","Will include cardiac troponins (I \\& T), NT-pro-BNP, and IL-6 measured in collected blood samples through University of Washington Research Testing Service.",{"measure":110,"description":111,"timeFrame":90},"Changes in quality of life","Will be assessed using the Functional Assessment of Cancer Therapy Bone Marrow Transplant questionnaire. Total scores range from 0-148, with higher scores indicating better outcome.","ALL","18 Years",null,{"inclusion":116,"exclusion":128,"raw_text":137},[117,118,119,120,121,122,123,124,125,126,127],"Age 18 years or older","Ability to understand and willingness to sign a written informed consent document","New diagnosis of acute myeloid leukemia at Fred Hutch","High-risk patients as defined by one, or more, of the following criteria:","Age 65 years or older and\u002For","Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) score ≥ 3 (for patients 20 years old or older) and\u002For","CARE-BMT score ≥ 5","Note: HCT-CI and CARE-BMT scores will be measured at pre-screening by study staff","Able to exercise at low to moderate intensity, as evaluated by study staff","Access to a mobile smart phone","Able to read and write in English",[129,130,131,132,133,134,135,136],"Orthopedic, neurologic, or other problems that prevent safe ambulation and protocol adherence. Information on prior falls and other recent orthopedic or neurologic problems will be used to make judgment about protocol eligibility","Recurrence of AML or diagnosis of other invasive cancer","Severe anemia (hemoglobin \\\u003C 7 gm\u002Fdl)","History of severe aortic stenosis","New York Heart Association (NYHA) class IV heart failure","Severe pain with basic movement","Pregnant persons","Unable to give consent","Inclusion Criteria:\n\n* Age 18 years or older\n* Ability to understand and willingness to sign a written informed consent document\n* New diagnosis of acute myeloid leukemia at Fred Hutch\n* High-risk patients as defined by one, or more, of the following criteria:\n\n  * Age 65 years or older and\u002For\n  * Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) score ≥ 3 (for patients 20 years old or older) and\u002For\n  * CARE-BMT score ≥ 5\n\n    * Note: HCT-CI and CARE-BMT scores will be measured at pre-screening by study staff\n* Able to exercise at low to moderate intensity, as evaluated by study staff\n* Access to a mobile smart phone\n* Able to read and write in English\n\nExclusion Criteria:\n\n* Orthopedic, neurologic, or other problems that prevent safe ambulation and protocol adherence. Information on prior falls and other recent orthopedic or neurologic problems will be used to make judgment about protocol eligibility\n* Recurrence of AML or diagnosis of other invasive cancer\n* Severe anemia (hemoglobin \\\u003C 7 gm\u002Fdl)\n* History of severe aortic stenosis\n* New York Heart Association (NYHA) class IV heart failure\n* Severe pain with basic movement\n* Pregnant persons\n* Unable to give consent",[139,140],"ADULT","OLDER_ADULT",[142],{"facility":143,"city":144,"state":145,"zip":146,"country":147,"contacts":148,"geoPoint":156},"Fred Hutch\u002FUniversity of Washington Cancer Consortium","Seattle","Washington","98109","United States",[149,154],{"name":150,"role":151,"phone":152,"email":153},"Alexi Vasbinder, PhD, RN","CONTACT","206-221-4390","avasbind@uw.edu",{"name":150,"role":155},"PRINCIPAL_INVESTIGATOR",{"lat":157,"lon":158},47.60621,-122.33207,[160],{"name":150,"role":151,"phone":152,"email":153},[162],{"name":150,"affiliation":143,"role":155},[],[],{"nct_id":4,"conditions":166,"biomarkers":167},[19],[],{"nct_id":4,"found":15,"summary":114,"prompt_version":114}]