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.
18 years of age or older
Scheduled to undergo a first allogeneic hematopoietic stem cell transplantation (HSCT) with an inpatient hospital stay for a myeloid blood disorder
Cleared by the treating physician to participate in physical exercise before and after HSCT
Able to move around independently or with the use of an assistive device
An acute medical condition that makes physical exercise unsafe, as determined by the treating physician
Cognitive or mental health problems that prevent safe participation in the exercise program or understanding of the study procedures
Pregnancy or plans to become pregnant during the 12-week study intervention
Insufficient German language skills to participate safely in the exercise program or to complete the study assessments
Parallel
Multimodal Exercise Intervention
BehavioralParticipants 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.
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.
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.
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.
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.
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.
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.
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.
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.
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