[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659771":3},{"organization":4,"outcomesModule":7,"designInfo":135,"detailedDescription":138,"studyPopulation":138,"armGroups":142,"interventions":153,"overallOfficials":159,"centralContacts":164,"locations":174,"responsibleParty":190,"collaborators":138,"id":193,"slug":194,"hasResults":195,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":195,"sex":201,"minAge":202,"maxAge":138,"enrollmentInfo":203,"targetDuration":138,"studyType":206,"phases":207,"briefSummary":209,"conditions":210,"keywords":212,"overallStatus":222,"whyStopped":138,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":232},{"fullName":5,"class":6},"Universität Duisburg-Essen","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":83},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Executive Function Composite Score From Hospital Discharge to 13 Weeks After Discharge","Executive function is assessed using a standardized composite score derived from performance on the Flanker Task (reaction time, error rate, and flanker effect), Trail Making Test Part B (completion time), and Digit Span Backward (score). Individual test measures are standardized and combined into a composite score representing executive function, including inhibitory control, cognitive flexibility, and working memory. Test measures are transformed as needed so that higher composite scores indicate better executive function.","Hospital discharge (T1) and 13 weeks after hospital discharge, following the 12-week intervention or control period (T2)",[14,18,22,25,28,31,34,37,40,43,46,50,53,56,59,62,66,69,73,77,80],{"measure":15,"description":16,"timeFrame":17},"Change in Global Cognitive Function Assessed by the Montreal Cognitive Assessment (MoCA)","Global cognitive function is assessed using the Montreal Cognitive Assessment (MoCA). The total score ranges from 0 to 30, with higher scores indicating better global cognitive function.","Pre-HSCT (T0), hospital discharge (T1), and 13 weeks after hospital discharge (T2)",{"measure":19,"description":20,"timeFrame":21},"Change in Reaction Time Assessed by the OORTT 4 Positions Reaction Times","Reaction time is assessed using the OORTT 4 Positions Reaction Times and reported in milliseconds (ms). Lower values indicate faster responses.","Hospital discharge (T1) and 13 weeks after hospital discharge (T2)",{"measure":23,"description":24,"timeFrame":17},"Change in Inhibitory Control Assessed by the Flanker Task","Inhibitory control is assessed using the Flanker Task. The primary task-specific outcome is the reaction-time-based flanker interference effect, calculated as the difference in mean reaction time between incongruent and congruent trials and expressed in milliseconds (ms). A smaller interference effect indicates better inhibitory control. Reaction time and error rate are additionally recorded as task performance parameters.",{"measure":26,"description":27,"timeFrame":21},"Change in Cognitive Flexibility Assessed by Trail Making Test Part B","Cognitive flexibility and task switching are assessed using Trail Making Test Part B. The outcome is completion time in seconds, with shorter completion times indicating better performance.",{"measure":29,"description":30,"timeFrame":21},"Change in Working Memory Assessed by Digit Span Backward","Working memory is assessed using Digit Span Backward. The outcome is the total score according to the standardized scoring procedure, with higher scores indicating better working-memory performance.",{"measure":32,"description":33,"timeFrame":17},"Change in Static Balance Assessed by the 4-Stage Balance Test","Static balance is assessed using the 4-Stage Balance Test, consisting of four progressively more difficult standing positions. Each position is held for up to 10 seconds. The outcome is the highest stage successfully maintained for 10 seconds, ranging from 0 to 4, with higher values indicating better static balance.",{"measure":35,"description":36,"timeFrame":17},"Change in Maximum Isometric Handgrip Strength","Maximum isometric handgrip strength is assessed using the CITEC Handheld Dynamometer Advanced Kit and expressed as peak force in Newtons (N). Three valid maximal trials are performed with the dominant hand, and the highest peak force is used for analysis. Higher values indicate greater handgrip strength.",{"measure":38,"description":39,"timeFrame":17},"Change in isometric knee flexor strength (hand-held dynamometry)","Isometric knee flexor strength is assessed using the CITEC Handheld Dynamometer Advanced Kit and expressed as peak force in Newtons (N). Three valid maximal isometric knee extension trials are performed with the dominant leg, and the mean peak force of the three trials is used for analysis. Higher values indicate greater knee extensor strength.",{"measure":41,"description":42,"timeFrame":17},"Change in Functional Lower-Extremity Performance Assessed by the 30-Second Sit-to-Stand Test","Functional lower-extremity performance is assessed using the 30-Second Sit-to-Stand Test. The outcome is the number of complete sit-to-stand repetitions performed within 30 seconds. Higher values indicate better functional performance.",{"measure":44,"description":45,"timeFrame":17},"Change in Peak Work Rate Assessed by the Steep Ramp Test","Exercise capacity is assessed using the Steep Ramp Test performed on a cycle ergometer. The outcome is peak work rate (WRpeak), expressed in watts (W), achieved at the end of the test. Higher values indicate greater exercise capacity.",{"measure":47,"description":48,"timeFrame":49},"Change in Perceived Cognitive Impairment Assessed by the FACT-Cog Version 3","Perceived cognitive impairment is assessed using the Perceived Cognitive Impairments (PCI) subscale of the Functional Assessment of Cancer Therapy-Cognitive Function, Version 3 (FACT-Cog v3). The PCI score ranges from 0 to 72, with higher scores indicating better self-reported cognitive function and fewer perceived cognitive impairments.","Hospital discharge (T1), 13 weeks (T2), 6 months (T3), and 12 months (T4) after hospital discharge",{"measure":51,"description":52,"timeFrame":49},"Change in Global Health Status and Quality of Life Assessed by the EORTC QLQ-C30","Global health status and quality of life are assessed using the Global Health Status\u002FQuality of Life scale of the EORTC QLQ-C30. Scores are transformed to a scale from 0 to 100 according to the EORTC scoring manual, with higher scores indicating better global health status and quality of life.",{"measure":54,"description":55,"timeFrame":49},"Change in General Self-Efficacy Assessed by the ASKU","General self-efficacy is assessed using the Allgemeine Selbstwirksamkeit Kurzskala (ASKU). The mean score ranges from 1 to 5, with higher scores indicating greater general self-efficacy.",{"measure":57,"description":58,"timeFrame":49},"Change in Depressive Symptoms Assessed by the Patient Health Questionnaire-9 (PHQ-9)","Depressive symptoms are assessed using the 9-item Patient Health Questionnaire (PHQ-9). Total scores range from 0 to 27, with higher scores indicating greater depressive symptom severity.",{"measure":60,"description":61,"timeFrame":49},"Change in Patient-Reported Symptoms Assessed by the PRO-CTCAE","Symptoms and treatment-related adverse effects are assessed using pre-specified items from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Selected symptom attributes such as frequency, severity, and interference are analyzed at the item level according to the respective PRO-CTCAE response scales. Higher values indicate greater symptom burden where applicable.",{"measure":63,"description":64,"timeFrame":65},"Change in Leisure-Time Physical Activity Assessed by the Godin Leisure-Time Exercise Questionnaire","Leisure-time physical activity is assessed using the Godin Leisure-Time Exercise Questionnaire. The primary metric is the Leisure Score Index, calculated from the reported weekly frequencies of strenuous, moderate, and mild leisure-time physical activity. Higher scores indicate greater leisure-time physical activity.","Pre-HSCT (T0), weekly during hospitalization, hospital discharge (T1), weekly during the 12-week intervention\u002Fcontrol period, 13 weeks (T2), 6 months (T3), and 12 months (T4) after hospital discharge",{"measure":67,"description":68,"timeFrame":65},"Change in Sitting Time Assessed Using Items From the International Physical Activity Questionnaire (IPAQ)","Sedentary behavior is assessed using selected sitting-time items from the International Physical Activity Questionnaire (IPAQ). The outcome is average daily sitting time, expressed in minutes per day. Higher values indicate more time spent sitting.",{"measure":70,"description":71,"timeFrame":72},"Social and Occupational Reintegration After Hospital Discharge","Reintegration is assessed using pre-specified study-specific questions addressing return to everyday activities, employment or education, and social participation following allogeneic HSCT. Responses are analyzed at the item level according to the respective response categories.","13 weeks (T2), 6 months (T3), and 12 months (T4) after hospital discharge",{"measure":74,"description":75,"timeFrame":76},"Occurrence and Severity of Graft-Versus-Host Disease","Acute and\u002For chronic graft-versus-host disease (GvHD) is obtained from routine clinical records. GvHD status at hospital discharge and occurrence or progression during follow-up are documented, including clinically assessed grade or stage where applicable.","Hospital discharge (T1) through 12 months after hospital discharge (T4)",{"measure":78,"description":79,"timeFrame":76},"Incidence of Infections","Clinically documented infections occurring after hospital discharge are obtained from routine clinical records. The number of infections per participant is recorded and infections are additionally characterized by type and severity.",{"measure":81,"description":82,"timeFrame":76},"Number of Rehospitalizations","The number of rehospitalizations occurring after hospital discharge is obtained from routine clinical records. Duration and reason for rehospitalization are additionally documented.",[84,88,91,94,97,100,103,106,110,114,118,121,124,128,132],{"measure":85,"description":86,"timeFrame":87},"Change in White Blood Cell Count","White blood cell count is obtained from routine clinical laboratory data and expressed as ×10⁹\u002FL. Longitudinal changes are evaluated across the available study time points.","Pre-HSCT (T0) through 12 months after hospital discharge (T4), as available from routine clinical care",{"measure":89,"description":90,"timeFrame":87},"Change in Absolute Neutrophil Count","Absolute neutrophil count is obtained from routine clinical laboratory data and expressed as ×10⁹\u002FL. Longitudinal changes are evaluated across the available study time points.",{"measure":92,"description":93,"timeFrame":87},"Change in Absolute Lymphocyte Count","Absolute lymphocyte count is obtained from routine clinical laboratory data and expressed as ×10⁹\u002FL. Longitudinal changes are evaluated across the available study time points.",{"measure":95,"description":96,"timeFrame":87},"Change in Platelet Count","Platelet count is obtained from routine clinical laboratory data and expressed as ×10⁹\u002FL. Longitudinal changes are evaluated across the available study time points.",{"measure":98,"description":99,"timeFrame":87},"Change in Hemoglobin Concentration","Hemoglobin concentration is obtained from routine clinical laboratory data and expressed in g\u002FdL. Longitudinal changes are evaluated across the available study time points.",{"measure":101,"description":102,"timeFrame":87},"Change in C-Reactive Protein Concentration","C-reactive protein (CRP) concentration is obtained from routine clinical laboratory data, where available, and expressed in mg\u002FL. Longitudinal changes are evaluated across the available study time points.",{"measure":104,"description":105,"timeFrame":87},"Measurable Residual Disease Status","Measurable residual disease (MRD) status is obtained from routine clinical assessments using disease-specific methods and documented as positive or negative. Quantitative results are additionally recorded where available.",{"measure":107,"description":108,"timeFrame":109},"Donor Chimerism","Donor chimerism is obtained from routine clinical assessments following allogeneic HSCT and expressed as percentage donor chimerism, where available.","From allogeneic HSCT through 12 months after hospital discharge (T4), as available from routine clinical care",{"measure":111,"description":112,"timeFrame":113},"Time to Hematologic Recovery","Hematologic recovery following allogeneic HSCT is assessed from routine clinical laboratory data. Time to hematologic recovery is documented in days according to the definitions used in routine transplant care.","From allogeneic HSCT through hematologic recovery, as documented during follow-up through 12 months after hospital discharge (T4)",{"measure":115,"description":116,"timeFrame":117},"Exercise Intervention Adherence Rate","Adherence is calculated as the percentage of prescribed RESTART exercise sessions completed by participants assigned to the exercise intervention group. Higher percentages indicate greater adherence.","During the 12-week intervention period",{"measure":119,"description":120,"timeFrame":117},"Number of Completed Exercise Sessions","The total number of completed RESTART exercise sessions is recorded for participants assigned to the exercise intervention group. Sessions are additionally categorized as individual in-person, supervised online, or home-based sessions.",{"measure":122,"description":123,"timeFrame":117},"Exercise Training Frequency","Exercise training frequency is calculated as the mean number of completed RESTART exercise sessions per week among participants assigned to the exercise intervention group.",{"measure":125,"description":126,"timeFrame":127},"Participant Dropout Rate","The dropout rate is calculated as the proportion of enrolled participants who discontinue study participation before completion of the final follow-up assessment. Reasons for dropout are documented descriptively.","From enrollment through 12 months after hospital discharge (T4)",{"measure":129,"description":130,"timeFrame":131},"Number of Participants With Adverse Events During the Intervention or Control Period","The number of participants experiencing at least one adverse event during the intervention or control period is recorded. Adverse events are additionally characterized by type, severity, and possible relationship to the exercise intervention.","Hospital discharge (T1) through 13 weeks after hospital discharge (T2)",{"measure":133,"description":134,"timeFrame":131},"Number of Participants With Serious Adverse Events During the Intervention or Control Period","The number of participants experiencing at least one serious adverse event during the intervention or control period is recorded. Serious adverse events are additionally characterized by type, severity, and possible relationship to the exercise intervention.",{"allocation":136,"interventionModel":137,"interventionModelDescription":138,"primaryPurpose":139,"observationalModel":138,"timePerspective":138,"maskingInfo":140},"RANDOMIZED","PARALLEL",null,"SUPPORTIVE_CARE",{"masking":141,"maskingDescription":138,"whoMasked":138},"NONE",[143,149],{"label":144,"type":145,"description":146,"interventionNames":147},"Exercise Intervention Group","EXPERIMENTAL","Participants assigned to this arm receive the 12-week RESTART exercise intervention in addition to usual medical, nursing, and supportive care after allogeneic hematopoietic stem cell transplantation.",[148],"Behavioral: Multimodal Exercise Intervention",{"label":150,"type":151,"description":152,"interventionNames":138},"Usual Care Control Group","NO_INTERVENTION","Participants assigned to this arm receive usual medical, nursing, and supportive care during the 12-week control period. No additional RESTART exercise intervention is provided during this period. Medically indicated care and self-directed physical activity are not restricted.",[154],{"type":155,"name":156,"description":157,"armGroupLabels":158,"otherNames":138},"BEHAVIORAL","Multimodal Exercise Intervention","Participants receive a 12-week individualized, multimodal exercise intervention in addition to usual care, consisting of three sessions per week: one individual in-person session (approximately 60 minutes), one live supervised online session (approximately 45 minutes), and one independently performed home-based session (approximately 30 minutes). Across the intervention, exercise content may include aerobic, resistance, mobility, balance, coordination, and cognitive-motor exercises. Training duration, intensity, exercise selection, and volume are individually adapted to the participant's medical condition, physical capacity, treatment-related symptoms, daily condition, and personal goals. In-person and online sessions are supervised by qualified exercise therapists; home-based exercises are individually selected and explained in advance, with an emphasis on low-risk, easily controllable exercises that can be performed safely without direct supervision.",[144],[160],{"name":161,"affiliation":162,"role":163},"Miriam Goette, PD Dr. rer. medic.","University Hospital, Essen","PRINCIPAL_INVESTIGATOR",[165,170],{"name":166,"role":167,"phone":168,"phoneExt":138,"email":169},"Rebecca Zimmer, M.Sc.","CONTACT","+49 201 723 7305","rebecca.zimmer@uk-essen.de",{"name":171,"role":167,"phone":172,"phoneExt":138,"email":173},"Miriam Götte, PD Dr. rer. medic.","+49 201 723 8083","miriam.goette@uk-essen.de",[175],{"facility":176,"status":138,"city":177,"state":178,"zip":179,"country":180,"countryCode":181,"cosmosGeoPoint":182,"geoPoint":187,"contacts":188},"University Hospital Essen","Essen","North Rhine-Westphalia","45147","Germany","DE",{"type":183,"coordinates":184},"Point",[185,186],7.01228,51.45657,{"lat":186,"lon":185},[189],{"name":166,"role":167,"phone":168,"phoneExt":138,"email":169},{"type":163,"investigatorFullName":191,"investigatorTitle":192,"investigatorAffiliation":5,"oldNameTitle":138,"oldOrganization":138},"Miriam Götte","PD Dr. rer. medic.","100659771","exercise-intervention-to-support-recovery-after-allogeneic-stem-cell-transplantation-in-adults-with-myeloid-blood-disorders-100659771",false,"NCT07868653","Exercise Intervention to Support Recovery After Allogeneic Stem Cell Transplantation in Adults With Myeloid Blood Disorders","RESTART - Cognitive, Physiological, and Immunological Effects of a Multimodal Exercise Intervention in Patients After Allogeneic Hematopoietic Stem Cell Transplantation","RESTART","Inclusion Criteria:\n\n* 18 years of age or older\n* Scheduled to undergo a first allogeneic hematopoietic stem cell transplantation (HSCT) with an inpatient hospital stay for a myeloid blood disorder\n* Cleared by the treating physician to participate in physical exercise before and after HSCT\n* Able to move around independently or with the use of an assistive device\n* Sufficient German language skills to understand the study information and exercise instructions, report symptoms, and complete the study questionnaires\n* Able to understand the study and provide written informed consent\n* Able to take part in the supervised online exercise sessions, including access to an internet-enabled device and a sufficiently stable internet connection\n\nExclusion Criteria:\n\n* An acute medical condition that makes physical exercise unsafe, as determined by the treating physician\n* Cognitive or mental health problems that prevent safe participation in the exercise program or understanding of the study procedures\n* Pregnancy or plans to become pregnant during the 12-week study intervention\n* Insufficient German language skills to participate safely in the exercise program or to complete the study assessments\n* Participation in another structured exercise or training program that could affect the study results. Normal daily activities and self-directed physical activity are allowed.","ALL","18 Years",{"count":204,"type":205},80,"ESTIMATED","INTERVENTIONAL",[208],"NA","The goal of this clinical trial is to learn how a 12-week exercise intervention affects recovery after allogeneic stem cell transplantation in adults with a myeloid blood disorder. The main question is whether the exercise intervention helps maintain or improve thinking skills, especially attention, mental flexibility, and working memory, compared with usual care. The study will also look at physical function, quality of life, symptoms, activity levels, and clinical recovery.\n\nAfter leaving the hospital following stem cell transplantation, participants will be randomly assigned to one of two groups. One group will receive the 12-week exercise intervention in addition to usual care. The other group will receive usual care without an additional RESTART exercise program during these 12 weeks.\n\nParticipants in the exercise group will complete three exercise sessions each week: one individual in-person session, one guided online session, and one home-based session.\n\nThe exercises may include endurance, strength, mobility, balance, coordination, and activities that combine movement with thinking tasks. The program will be adjusted to each participant's health, fitness, symptoms, and daily condition.\n\nAll participants will complete study assessments shortly before transplantation, at hospital discharge, and after the 12-week intervention or control period. Follow-up assessments will also take place 6 and 12 months after discharge, mainly using questionnaires and clinical information from routine care.",[211],"Myeloid Malignancies",[213,211,214,215,216,217,218,219,220,221],"Allogeneic Hematopoietic Stem Cell Transplantation","Exercise Intervention","Exercise Therapy","Exercise Oncology","Executive Function","Cognitive Function","Physical Performance","Quality of Life","Rehabilitation","NOT_YET_RECRUITING","2026-09-30",{"date":225,"type":226},"2026-10-09","ACTUAL",{"date":228,"type":205},"2026-10-01",{"date":230,"type":205},"2030-07-01",{"name":5,"class":6},1]