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NCT Number: NCT07341698

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Copenhagen University Hospital - Rigshospitalet

Copenhagen, Denmark, 2100

Location status: Recruiting

Location contact

Lone S Friis, Senior physician hematologist

SUB_INVESTIGATOR

Magnus N Bech, PhD Student

CONTACT

[email protected]

+4535453484

Mary Jarden, Professor

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resistance training

Other

Structured and supervised, group-based, resistance training 3x per week (individually tailored to the individual's capabilities)

Other names: Exercise, Prehabilitation

Nutritional Support

Dietary Supplement

Optimized dietary counseling and supplementation to optimize nutritional intake

Other names: Prehabilitation, dietary counseling, nutrition

usual care

Procedure

Usual care is the standard care before allogeneic hematopoietic stem cell transplantation

Other names: HSCT, allogeneic hematopoietic stem cell transplantation, hematopoietic stem cell transplantation

Primary outcomes

  1. 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.

Secondary outcomes

  1. Hospitalization

    Time frame: From enrollment to 90 days post-transplantation

    Days of hospitalization

  2. Appendicular lean mass

    Time frame: From enrollment to 90 days post-transplantation

    Measured using dual-energy X-ray absorptiometry (DXA)

  3. Appendicular Lean Mass Index

    Time frame: From enrollment to 90 days post-transplantation

    To account for body size, ALM is divided by height squared

  4. Hand grip strength

    Time frame: From enrollment to 90 days post-transplantation.

    Using a handheld electronical dynamometer

  5. Lower limb strength

    Time frame: From enrollment to 90 days post-transplantation.

    5-repetition Sit-to-stand Test

  6. Lower limb strength and endurance

    Time frame: From enrollment to 90 days post-transplantation.

    30-second Sit-to-stand Test

  7. Leg Extensor Power

    Time frame: From enrollment to 90 days post-transplantation

    Measured using a Nottingham Power Rig,

Other outcomes

  1. 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

  2. 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

  3. Physical activity monitoring

    Time frame: From enrollment to 90 days post-transplantation

    Daily steps

  4. Self reported physical activity

    Time frame: From enrollment to 90 days post-transplantation

    International Physical Activity Questionnaire short form (IPAQ-sf)

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. Days of hospitalization

    Time frame: From enrollment to 90 days and 1, 3 and 5 years after transplantation

    Days of hospitalization

  10. Survival

    Time frame: 1, 3 and 5 years after transplantation

    All-course survival with-out progression or relapse

  11. 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

  12. 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.

  13. 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

  14. 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

  15. Exercise habits

    Time frame: 1,3 and 5 years after transplantation

    Exercise habits rapported by International Physical Activity Questionnaire (IPAQ)

  16. 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.

  17. 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

  18. Transfusion need

    Time frame: From day 0 to day 90

    Days after transplantation with being independent of bloodtransfusions

  19. Acute GvHD

    Time frame: Development of > grade 2 Acute GvHD from day 0 to day 90

    Development of Acute GvHD

Study contacts

Contact information is provided by the study sponsor or research team.

Jan Christensen, PhD

CONTACT

[email protected]

+4522479075

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Aarhus University Hospital

Registry information

Official study title

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

Acronym: PrepAllo

Important dates

Study start
2026
Primary completion
2028
Study completion
2032
First posted
Jan 14, 2026
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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