Prehabilitation for Patients Diagnosed With Blood Cancer and Treated With Al-logeneic Hematopoietic Stem Cell Transplantation (PrepAllo)

January 27, 2026 updated by: Jan Christensen, Rigshospitalet, Denmark

Prehabilitation for Patients Diagnosed With Blood Cancer and Treated With Alloge-neic Hematopoietic Stem Cell Transplantation - a National Randomized Controlled Trial

Seventy-five percent of patients treated with hematopoietic stem cell transplants survive one-year post-transplantation. However, this intensive treatment is associated with prolonged hospitalizations and significant deconditioning. Pathophysiological changes in skeletal muscle mass and function have notable implications for disease progression and long-term prognosis. Patients frequently report substantial rehabilitation needs, though these needs are highly individualized and fluctuate over time, with musculoskeletal dysfunction and fa-tigue being the most common barriers to prehabilitation. Furthermore, at least 35% of cancer patients are found to have inadequate daily protein intake, which may hinder improve-ments in physical performance through prehabilitation. Several recent studies have demonstrated the safety and feasibility of exercise-based prehabilitation interventions during the pre-transplant period. However, no full-scale randomized controlled trial (RCT) has been conducted to date.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Evaluate the effectiveness of an individualized prehabilitation intervention in addition to usual care, compared to usual care alone on HRQoL, and secondary outcomes hospitalization, muscle mass and muscle function.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Denmark
    • Denmark
      • Copenhagen, Denmark, Denmark, 2100
        • Recruiting
        • Copenhagen University Hospital - Rigshospitalet
        • Contact:
        • Sub-Investigator:
          • Lone S Friis, Senior physician hematologist
        • Sub-Investigator:
          • Mary Jarden, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Adult patients >18 years will be eligible for inclusion if they are scheduled for a allo-HSCT with at least four weeks before their scheduled transplantation date.

Exclusion Criteria:

  • pregnancy
  • physical or mental disabilities precluding test of muscle function
  • inability to read and understand Danish or English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Usual care
The usual care group will receive standard care, including physio- and occupational therapy if admitted to the hospital, and potentially referral to rehabilitation in the municipality three months after transplantation.
Procedure: Usual care
Usual care is the standard care before allogeneic hematopoietic stem cell transplantation
Other Names:
  • HSCT
  • hematopoietic stem cell transplantation
  • allogeneic hematopoietic stem cell transplantation
Experimental: Usual care plus the prehabilitation intervention
The prehabilitation group will in addition to usual care receive supervised individually tailored resistance training and optimized nutritional support
Procedure: Usual care
Usual care is the standard care before allogeneic hematopoietic stem cell transplantation
Other Names:
  • HSCT
  • hematopoietic stem cell transplantation
  • allogeneic hematopoietic stem cell transplantation
Other: Resistance training
Structured and supervised, group-based, resistance training 3x per week (individually tailored to the individual's capabilities)
Other Names:
  • Exercise
  • Prehabilitation
Dietary supplement: Nutritional Support
Optimized dietary counseling and supplementation to optimize nutritional intake
Other Names:
  • dietary counseling
  • nutrition
  • Prehabilitation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Health-Related Quality of Life using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core questionnaires with 30 questions (EORTC QLQ C-30)
Time Frame: From enrollment to 90 days post-transplantation
HRQoL measured using EORCT-C30v3.0. Scores are from 0 to 100 with lower scores meaning poorer quality of life and high scores meaning better overall quality of life.
From enrollment to 90 days post-transplantation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hospitalization
Time Frame: From enrollment to 90 days post-transplantation
Days of hospitalization
From enrollment to 90 days post-transplantation
Appendicular lean mass
Time Frame: From enrollment to 90 days post-transplantation
Measured using dual-energy X-ray absorptiometry (DXA)
From enrollment to 90 days post-transplantation
Appendicular Lean Mass Index
Time Frame: From enrollment to 90 days post-transplantation
To account for body size, ALM is divided by height squared
From enrollment to 90 days post-transplantation
Hand grip strength
Time Frame: From enrollment to 90 days post-transplantation.
Using a handheld electronical dynamometer
From enrollment to 90 days post-transplantation.
Lower limb strength
Time Frame: From enrollment to 90 days post-transplantation.
5-repetition Sit-to-stand Test
From enrollment to 90 days post-transplantation.
Lower limb strength and endurance
Time Frame: From enrollment to 90 days post-transplantation.
30-second Sit-to-stand Test
From enrollment to 90 days post-transplantation.
Leg Extensor Power
Time Frame: From enrollment to 90 days post-transplantation
Measured using a Nottingham Power Rig,
From enrollment to 90 days post-transplantation

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Habitual gait speed
Time Frame: From enrollment to 90 days post transplantation
10-Meter walk test: Time to walk 10 meter distance at a preferred speed
From enrollment to 90 days post transplantation
Physical activity monitoring monitored with the use og SENS motion wearable activity sensors. Outcome will be reported in metabolic equivalents (METS)
Time Frame: From enrollment to 90 days post-transplantation
Moderate to Vigorous Physical Activity (MVPA) will be measured with algorithms from the use of SENS motion wearables
From enrollment to 90 days post-transplantation
Physical activity monitoring
Time Frame: From enrollment to 90 days post-transplantation
Daily steps
From enrollment to 90 days post-transplantation
Self reported physical activity
Time Frame: From enrollment to 90 days post-transplantation
International Physical Activity Questionnaire short form (IPAQ-sf)
From enrollment to 90 days post-transplantation
Karnofsky Performance Status
Time Frame: From enrollment to 90 days after transplantation
Changes in Karnofsky Performance Status. Minimum value is 0 and maximum value is 100. A score of 100 equals normal function in performing daily activities while a score of 0 is equal to death. Thus, the lower scores the poorer performance of daily activities.
From enrollment to 90 days after transplantation
Symptoms of anxiety using Hospital Anxiety and Depression Scale (HADS)
Time Frame: From enrollment to 90 days post-transplantation
Symptoms of anxiety measured using HADS. The item is separated in two parts. One is scoring anxiety level and one is scoring depression level. The minimum value is 0 while the maximum for each scale is 21 for each scale (21 for anxiety and 21 for depression). The higher score the more severe symptoms of either anxiety or depression. Scores above 11 in each category is considered to be moderate to severe symptoms with action needed to be taken on the condition.
From enrollment to 90 days post-transplantation
Symptoms of depression using Hospital Anxiety and Depression Scale (HADS)
Time Frame: From enrollment to 90 days post-transplantation
Symptoms of depression measured using HADS. Symptoms of anxiety measured using HADS. The item is separated in two parts. One is scoring anxiety level and one is scoring depression level. The minimum value is 0 while the maximum for each scale is 21 for each scale (21 for anxiety and 21 for depression). The higher score the more severe symptoms of either anxiety or depression. Scores above 11 in each category is considered to be moderate to severe symptoms with action needed to be taken on the condition.
From enrollment to 90 days post-transplantation
Health literacy mesured using the Health Literacy Questionnaire (HLQ).
Time Frame: From enrollment to 90 days post-transplantation
Health literacy was assessed using the Health Literacy Questionnaire (HLQ). The HLQ comprises nine independent scales scored as the mean of their constituent items. Scales 1-5 are scored from 1 to 4, and scales 6-9 from 1 to 5, with higher scores indicating better health literacy.
From enrollment to 90 days post-transplantation
Days of hospitalization
Time Frame: From enrollment to 90 days and 1, 3 and 5 years after transplantation
Days of hospitalization
From enrollment to 90 days and 1, 3 and 5 years after transplantation
Survival
Time Frame: 1, 3 and 5 years after transplantation
All-course survival with-out progression or relapse
1, 3 and 5 years after transplantation
Interviews
Time Frame: Participants will be asked to participate in interviews at time for recruitment (6-8 weeks before transplantation), at end of interventionperiod (day -7 to 0 before transplantation) and after last follow-up tests at day +90 after transplantation.
Participants will be asked to participate in interviews during the study period
Participants will be asked to participate in interviews at time for recruitment (6-8 weeks before transplantation), at end of interventionperiod (day -7 to 0 before transplantation) and after last follow-up tests at day +90 after transplantation.
Complete remission
Time Frame: at day +90 and 1,3 and 5 years after transplantation
Complete remission objective measured and evaluated by responsible physician. Complete remission is defined as full donor dhimerism if >95 % of bone marrow cells measured from chimerism is from donor.
at day +90 and 1,3 and 5 years after transplantation
Cancer Progression
Time Frame: At 1, 3 and 5 years after transplantation
Progression of the underlying hematologic malignancy will be defined as objective worsening of disease burden after transplantation among patients who have not achieved complete remission after HSCT
At 1, 3 and 5 years after transplantation
Cancer recurrence
Time Frame: 1,3 and 5 years after transplantation
Recurrence (relapse) will be defined as reappearance of the original hematologic malignancy in a patient who has previously achieved complete remission after HSCT
1,3 and 5 years after transplantation
Exercise habits
Time Frame: 1,3 and 5 years after transplantation
Exercise habits rapported by International Physical Activity Questionnaire (IPAQ)
1,3 and 5 years after transplantation
Secondary malignancy
Time Frame: At 1, 3 and 5 years after transplantation
Secondary malignancy will be defined as the occurrence of any new hematologic or solid malignant disease after HSCT that is genetically or clinically distinct from the primary malignancy for which the transplant was performed.
At 1, 3 and 5 years after transplantation
Engraftment
Time Frame: From enrollment to 90 days after transplantation
Time from transplantation to first of three following days with absolute neutrophiles >0,5 x10^9 /L
From enrollment to 90 days after transplantation
Transfusion need
Time Frame: From day 0 to day 90
Days after transplantation with being independent of bloodtransfusions
From day 0 to day 90
Acute GvHD
Time Frame: Development of > grade 2 Acute GvHD from day 0 to day 90
Development of Acute GvHD
Development of > grade 2 Acute GvHD from day 0 to day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rigshospitalet, Denmark

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 12, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 12, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 12, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-25053677
  • MS25-01447 (Other Grant/Funding Number: Danish Cancer Society)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The investigators have agree to make data and materials supporting the results and analyses available upon reasonable request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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