Myeloid MalignanciesRESTARTNCT07868653
Exercise Intervention to Support Recovery After Allogeneic Stem Cell Transplantation in Adults With Myeloid Blood Disorders
A study testing Multimodal Exercise Intervention in people with Myeloid Malignancies, run by Universität Duisburg-Essen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloid Malignancies
- What is being tested?
- Multimodal Exercise Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2026to 1 Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
University Hospital Essen
Essen, North Rhine-Westphalia, 45147
Rebecca Zimmer, M.Sc., +49 201 723 7305, rebecca.zimmer@uk-essen.de
About this study
Official title: RESTART - Cognitive, Physiological, and Immunological Effects of a Multimodal Exercise Intervention in Patients After Allogeneic Hematopoietic Stem Cell Transplantation
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.
Read more
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.
- Conditions
- Myeloid Malignancies
- Being tested
- Multimodal Exercise Intervention
- Keywords
- Allogeneic Hematopoietic Stem Cell Transplantation, Myeloid Malignancies, Exercise Intervention, Exercise Therapy, Exercise Oncology, Executive Function, Cognitive Function, Physical Performance, Quality of Life, Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Exercise InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Multimodal Exercise Intervention |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Hospital discharge (T1) and 13 weeks after hospital discharge, following the 12-week intervention or control period (T2)
Secondary outcomes (21)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Hospital discharge (T1) through 12 months after hospital discharge (T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Sep 2029 (estimated)
- Study completion1 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloid MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miriam Götte, Universität Duisburg-Essen
- Investigators
- Miriam Goette, PD Dr. rer. medic., Principal investigator, University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868653
- Sponsor's protocol ID
- 26-13152-BO
- Acronym
- RESTART
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RESTART - Cognitive, Physiological, and Immunological Effects of a Multimodal Exercise Intervention in Patients After Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT07868653
- Acronym / sponsor ID
- RESTART / 26-13152-BO
- Conditions
- Myeloid Malignancies
- Keywords
- Allogeneic Hematopoietic Stem Cell Transplantation, Myeloid Malignancies, Exercise Intervention, Exercise Therapy, Exercise Oncology, Executive Function, Cognitive Function, Physical Performance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 1 Jul 2030 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention Group | Experimental | Behavioral: Multimodal Exercise InterventionParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal Exercise InterventionParticipants 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. | Behavioural | Exercise Intervention Group |
Primary outcome
Change in Executive Function Composite Score From Hospital Discharge to 13 Weeks After Discharge
Time frame: Hospital discharge (T1) and 13 weeks after hospital discharge, following the 12-week intervention or control period (T2)
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.
21 secondary outcomes
Change in Global Cognitive Function Assessed by the Montreal Cognitive Assessment (MoCA)
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
Time frame: Hospital discharge (T1) and 13 weeks after hospital discharge (T2)
Change in Inhibitory Control Assessed by the Flanker Task
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
Time frame: Hospital discharge (T1) and 13 weeks after hospital discharge (T2)
Change in Working Memory Assessed by Digit Span Backward
Time frame: Hospital discharge (T1) and 13 weeks after hospital discharge (T2)
Change in Static Balance Assessed by the 4-Stage Balance Test
Time frame: Pre-HSCT (T0), hospital discharge (T1), and 13 weeks after hospital discharge (T2)
Change in Maximum Isometric 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)
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
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
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
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
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
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)
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
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
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)
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
Time frame: 13 weeks (T2), 6 months (T3), and 12 months (T4) after hospital discharge
Occurrence and Severity of Graft-Versus-Host Disease
Time frame: Hospital discharge (T1) through 12 months after hospital discharge (T4)
Incidence of Infections
Time frame: Hospital discharge (T1) through 12 months after hospital discharge (T4)
Number of Rehospitalizations
Time frame: Hospital discharge (T1) through 12 months after hospital discharge (T4)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Miriam Goette, PD Dr. rer. medic. principal investigator
University Hospital, Essen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Exercise Intervention in people with Myeloid Malignancies, run by Universität Duisburg-Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca Zimmer, M.Sc. (+49 201 723 7305, rebecca.zimmer@uk-essen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Executive Function Composite Score From Hospital Discharge to 13 Weeks After Discharge (time frame: Hospital discharge (T1) and 13 weeks after hospital discharge, following the 12-week intervention or control period (T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.