Allogeneic Hematopoietic Stem Cell Transplantation RecipientPrepAlloNCT07341698
Prehabilitation for Patients Diagnosed With Blood Cancer and Treated With Al-logeneic Hematopoietic Stem Cell Transplantation
A study testing Resistance training and Nutritional Support in people with Allogeneic Hematopoietic Stem Cell Transplantation Recipient, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allogeneic Hematopoietic Stem Cell Transplantation Recipient
- What is being tested?
- Resistance training and Nutritional Support
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Jan 2026to 12 Oct 2032
- 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
- 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.
Who cannot join
- pregnancy
- physical or mental disabilities precluding test of muscle function
- inability to read and understand Danish or English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Copenhagen University Hospital - Rigshospitalet
Copenhagen, Denmark, 2100
Magnus N Bech, PhD Student, +4535453484, magnus.nygaard.bech@regionh.dk
Lone S Friis, Senior physician hematologist
About this study
Official title: 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.
Read the 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.
- Being tested
- Resistance training, Nutritional Support, Usual care
- Keywords
- Prehabilitation, Exercise, resistance training, nutritional support
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance trainingOther
Also called Exercise, Prehabilitation
Structured and supervised, group-based, resistance training 3x per week (individually tailored to the individual's capabilities)
Nutritional SupportDietary supplement
Also called Prehabilitation, dietary counseling, nutrition
Optimized dietary counseling and supplementation to optimize nutritional intake
Usual careProcedure or surgery
Also called HSCT, allogeneic hematopoietic stem cell transplantation, hematopoietic stem cell transplantation
Usual care is the standard care before allogeneic hematopoietic stem cell transplantation
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | 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. Receives: Procedure: Usual care |
| Usual care plus the prehabilitation intervention | Experimental | The prehabilitation group will in addition to usual care receive supervised individually tailored resistance training and optimized nutritional support Receives: Other: Resistance training; Dietary Supplement: Nutritional Support; Procedure: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
Measured: From enrollment to 90 days post-transplantation
Secondary outcomes (7)
Hospitalization
Days of hospitalization
Measured: From enrollment to 90 days post-transplantation
Appendicular lean mass
Measured using dual-energy X-ray absorptiometry (DXA)
Measured: From enrollment to 90 days post-transplantation
Appendicular Lean Mass Index
To account for body size, ALM is divided by height squared
Measured: From enrollment to 90 days post-transplantation
Hand grip strength
Using a handheld electronical dynamometer
Measured: From enrollment to 90 days post-transplantation.
Lower limb strength
5-repetition Sit-to-stand Test
Measured: From enrollment to 90 days post-transplantation.
Lower limb strength and endurance
30-second Sit-to-stand Test
Measured: From enrollment to 90 days post-transplantation.
Leg Extensor Power
Measured using a Nottingham Power Rig,
Measured: From enrollment to 90 days post-transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start12 Jan 2026
- Primary completion12 Jan 2028 (estimated)
- Study completion12 Oct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allogeneic Hematopoietic Stem Cell Transplantation RecipientStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a multicenter RCT. Based on a 1:1 randomization ratio, participants will be allo-cated to either usual care or usual care plus the prehabilitation intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Principal investigator, Jan Christensen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07341698
- Sponsor's protocol ID
- H-25053677
- Other IDs
- MS25-01447
- Acronym
- PrepAllo
- Status last verified
- Jan 2026
- First submitted
- 10 Dec 2025
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators have agree to make data and materials supporting the results and analyses available upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehabilitation for Patients Diagnosed With Blood Cancer and Treated With Alloge-neic Hematopoietic Stem Cell Transplantation - a National Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07341698
- Acronym / sponsor ID
- PrepAllo / H-25053677
- Keywords
- Prehabilitation, Exercise, resistance training, nutritional support
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- 12 Jan 2028 (estimated)
- Study completion
- 12 Oct 2032 (estimated)
- First posted
- 14 Jan 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a multicenter RCT. Based on a 1:1 randomization ratio, participants will be allo-cated to either usual care or usual care plus the prehabilitation intervention.
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Procedure: Usual careThe 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. |
| Usual care plus the prehabilitation intervention | Experimental | Other: Resistance training, Dietary Supplement: Nutritional Support, Procedure: Usual careThe prehabilitation group will in addition to usual care receive supervised individually tailored resistance training and optimized nutritional support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- pregnancy
- physical or mental disabilities precluding test of muscle function
- inability to read and understand Danish or English
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 |
|---|---|---|
| Resistance trainingAlso: Exercise, PrehabilitationStructured and supervised, group-based, resistance training 3x per week (individually tailored to the individual's capabilities) | Other | Usual care plus the prehabilitation intervention |
| Nutritional SupportAlso: Prehabilitation, dietary counseling, nutritionOptimized dietary counseling and supplementation to optimize nutritional intake | Dietary supplement | Usual care plus the prehabilitation intervention |
| Usual careAlso: HSCT, allogeneic hematopoietic stem cell transplantation, hematopoietic stem cell transplantationUsual care is the standard care before allogeneic hematopoietic stem cell transplantation | Procedure or surgery | Usual care, Usual care plus the prehabilitation intervention |
Primary outcome
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.
7 secondary outcomes
Hospitalization
Time frame: From enrollment to 90 days post-transplantation
Appendicular lean mass
Time frame: From enrollment to 90 days post-transplantation
Appendicular Lean Mass Index
Time frame: From enrollment to 90 days post-transplantation
Hand grip strength
Time frame: From enrollment to 90 days post-transplantation.
Lower limb strength
Time frame: From enrollment to 90 days post-transplantation.
Lower limb strength and endurance
Time frame: From enrollment to 90 days post-transplantation.
Leg Extensor Power
Time frame: From enrollment to 90 days post-transplantation
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 29 Jan 2026.
- Individual participant dataSharing planned: Yes. The investigators have agree to make data and materials supporting the results and analyses available upon reasonable request
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance training and Nutritional Support in people with Allogeneic Hematopoietic Stem Cell Transplantation Recipient, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 1 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 29 Jan 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 Denmark. 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 Jan Christensen, PhD (+4522479075, jan.christensen.02@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 29 Jan 2026.