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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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
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.

Rebecca Zimmer, M.Sc. contact

+49 201 723 7305

rebecca.zimmer@uk-essen.de

Miriam Götte, PD Dr. rer. medic. contact

+49 201 723 8083

miriam.goette@uk-essen.de

Germany1 site
  • University Hospital Essen

    Essen, North Rhine-Westphalia, 45147

    Rebecca Zimmer, M.Sc., +49 201 723 7305, rebecca.zimmer@uk-essen.de

Other trials in Germany

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.

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 groups in NCT07868653
Study groupRoleWhat they receive
Exercise Intervention GroupExperimentalParticipants 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 GroupNo interventionParticipants 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.

  1. 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)
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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)

  20. 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)

  21. 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.

  1. First posted9 Oct 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion30 Sep 2029 (estimated)
  4. Study completion1 Jul 2030 (estimated)

Resources

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)
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

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.

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