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NCT07868653
Exercise Intervention to Support Recovery After Allogeneic Stem Cell Transplantation in Adults With Myeloid Blood Disorders
Conditions: Myeloid Malignancies
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 80
Sponsor: Universität Duisburg-Essen
Location: University Hospital Essen Essen North Rhine-Westphalia
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* 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
* Sufficient German language skills to understand the study information and exercise instructions, report symptoms, and complete the study questionnaires
* Able to understand the study and provide written informed consent
* Able to take part in the supervised online exercise sessions, including access to an internet-enabled device and a sufficiently stable internet connection
Exclusion Criteria:
* 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
* Participation in another structured exercise or training program that could affect the study results. Normal daily activities and self-directed physical activity are allowed.
Source: ClinicalTrials.gov (NCT07868653). StuddyBuddy aggregates publicly available trial information.