An interventional study of Multimodal Exercise Intervention in Myeloid Malignancies, sponsored by Universität Duisburg-Essen. Not yet recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Universität Duisburg-Essen · Not applicable, Interventional, and Supportive care
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.
After 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.
Participants 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.
The 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.
All 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.
Universität Duisburg-Essen is the lead sponsor of 85 studies on the registry; 14 are open to participants now.
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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.
Behavioral: Multimodal Exercise 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.
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.
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.
Time frame: Hospital discharge (T1) and 13 weeks after hospital discharge, following the 12-week intervention or control period (T2)
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.
Time frame: Pre-HSCT (T0), hospital discharge (T1), and 13 weeks after hospital discharge (T2)
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.
Time frame: Hospital discharge (T1) and 13 weeks after hospital discharge (T2)
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.
Time frame: Pre-HSCT (T0), hospital discharge (T1), and 13 weeks after hospital discharge (T2)
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.
Time frame: Hospital discharge (T1) and 13 weeks after hospital discharge (T2)
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.
Time frame: Hospital discharge (T1) and 13 weeks after hospital discharge (T2)
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.
Time frame: Pre-HSCT (T0), hospital discharge (T1), and 13 weeks after hospital discharge (T2)
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.
Time frame: Pre-HSCT (T0), hospital discharge (T1), and 13 weeks after hospital discharge (T2)
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.
Time frame: Pre-HSCT (T0), hospital discharge (T1), and 13 weeks after hospital discharge (T2)
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.
Time frame: Pre-HSCT (T0), hospital discharge (T1), and 13 weeks after hospital discharge (T2)
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.
Time frame: Pre-HSCT (T0), hospital discharge (T1), and 13 weeks after hospital discharge (T2)
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.
Time frame: Hospital discharge (T1), 13 weeks (T2), 6 months (T3), and 12 months (T4) after hospital discharge
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/Quality 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.
Time frame: Hospital discharge (T1), 13 weeks (T2), 6 months (T3), and 12 months (T4) after hospital discharge
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.
Time frame: Hospital discharge (T1), 13 weeks (T2), 6 months (T3), and 12 months (T4) after hospital discharge
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.
Time frame: Hospital discharge (T1), 13 weeks (T2), 6 months (T3), and 12 months (T4) after hospital discharge
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, including frequency, severity, and interference with daily activities, are analyzed at the item level according to the respective PRO-CTCAE response scales. Each attribute is scored from 0 to 4, with higher scores indicating greater symptom frequency, severity, or interference and therefore a worse outcome. No overall summary score is calculated.
Time frame: Hospital discharge (T1), 13 weeks (T2), 6 months (T3), and 12 months (T4) after hospital discharge
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 as (9 × weekly frequency of strenuous activity) + (5 × weekly frequency of moderate activity) + (3 × weekly frequency of mild activity). The Leisure Score Index has a minimum value of 0 and no predefined maximum value because the reported weekly activity frequencies are not capped. Higher scores indicate greater leisure-time physical activity and therefore a better outcome.
Time frame: Pre-HSCT (T0), weekly during hospitalization, hospital discharge (T1), weekly during the 12-week intervention/control period, 13 weeks (T2), 6 months (T3), and 12 months (T4) after hospital discharge
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, with a theoretical range from 0 to 1,440 minutes per day. Higher values indicate more time spent sitting and therefore a worse outcome.
Time frame: Pre-HSCT (T0), weekly during hospitalization, hospital discharge (T1), weekly during the 12-week intervention/control period, 13 weeks (T2), 6 months (T3), and 12 months (T4) after hospital discharge
Social and Occupational Reintegration After Hospital Discharge
Reintegration is assessed using the study-specific RESTART Reintegration Questionnaire following allogeneic hematopoietic stem cell transplantation (HSCT). Items on return to everyday life, social integration, and ability to manage important daily activities are rated from 1 ("not at all") to 5 ("completely"); higher scores indicate better reintegration. Reintegration into employment, education, studies, or a comparable regular activity is rated from 1 to 5, with higher scores indicating better reintegration; 0 indicates "not applicable" and is not interpreted as a lower score. Current employment/education status is assessed categorically. An open-ended item assesses factors facilitating or hindering reintegration. Items are analyzed separately; no overall summary score is calculated.
Time frame: 13 weeks (T2), 6 months (T3), and 12 months (T4) after hospital discharge
Occurrence and Severity of Graft-Versus-Host Disease
Acute and/or 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.
Time frame: Hospital discharge (T1) through 12 months after hospital discharge (T4)
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.
Time frame: Hospital discharge (T1) through 12 months after hospital discharge (T4)
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.
Time frame: Hospital discharge (T1) through 12 months after hospital discharge (T4)
Change in White Blood Cell Count
White blood cell count is obtained from routine clinical laboratory data and expressed as ×10⁹/L. Longitudinal changes are evaluated across the available study time points.
Time frame: Pre-HSCT (T0) through 12 months after hospital discharge (T4), as available from routine clinical care
Change in Absolute Neutrophil Count
Absolute neutrophil count is obtained from routine clinical laboratory data and expressed as ×10⁹/L. Longitudinal changes are evaluated across the available study time points.
Time frame: Pre-HSCT (T0) through 12 months after hospital discharge (T4), as available from routine clinical care
Change in Absolute Lymphocyte Count
Absolute lymphocyte count is obtained from routine clinical laboratory data and expressed as ×10⁹/L. Longitudinal changes are evaluated across the available study time points.
Time frame: Pre-HSCT (T0) through 12 months after hospital discharge (T4), as available from routine clinical care
Change in Platelet Count
Platelet count is obtained from routine clinical laboratory data and expressed as ×10⁹/L. Longitudinal changes are evaluated across the available study time points.
Time frame: Pre-HSCT (T0) through 12 months after hospital discharge (T4), as available from routine clinical care
Change in Hemoglobin Concentration
Hemoglobin concentration is obtained from routine clinical laboratory data and expressed in g/dL. Longitudinal changes are evaluated across the available study time points.
Time frame: Pre-HSCT (T0) through 12 months after hospital discharge (T4), as available from routine clinical care
Change in C-Reactive Protein Concentration
C-reactive protein (CRP) concentration is obtained from routine clinical laboratory data, where available, and expressed in mg/L. Longitudinal changes are evaluated across the available study time points.
Time frame: Pre-HSCT (T0) through 12 months after hospital discharge (T4), as available from routine clinical care
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.
Time frame: Pre-HSCT (T0) through 12 months after hospital discharge (T4), as available from routine clinical care
Donor Chimerism
Donor chimerism is obtained from routine clinical assessments following allogeneic HSCT and expressed as percentage donor chimerism, where available.
Time frame: From allogeneic HSCT through 12 months after hospital discharge (T4), as available from routine clinical care
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.
Time frame: From allogeneic HSCT through hematologic recovery, as documented during follow-up through 12 months after hospital discharge (T4)
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.
Time frame: During the 12-week intervention period
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.
Time frame: During the 12-week intervention period
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.
Time frame: During the 12-week intervention period
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.
Time frame: From enrollment through 12 months after hospital discharge (T4)
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.
Time frame: Hospital discharge (T1) through 13 weeks after hospital discharge (T2)
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.
Time frame: Hospital discharge (T1) through 13 weeks after hospital discharge (T2)
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Universität Duisburg-Essen