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

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: Recruiting
• Conditions: Allogeneic Hematopoietic Stem Cell Transplantation Recipient
• Intervention / Treatment: Procedure: Usual care; Other: Resistance training; Dietary supplement: Nutritional Support

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: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jan Christensen, PhD; Phone Number: +4522479075; Email: jan.christensen.02@regionh.dk

Study Locations

• Denmark
  • Denmark
    • Copenhagen, Denmark, Denmark, 2100
      • Recruiting
      • Copenhagen University Hospital - Rigshospitalet
      • Contact: Magnus N Bech, PhD Student; Phone Number: +4535453484; Email: magnus.nygaard.bech@regionh.dk
      • Sub-Investigator: Lone S Friis, Senior physician hematologist
      • Sub-Investigator: Mary Jarden, Professor

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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)	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

Outcome Measure	Measure Description	Time Frame
Hospitalization	Days of hospitalization	From enrollment to 90 days post-transplantation
Appendicular lean mass	Measured using dual-energy X-ray absorptiometry (DXA)	From enrollment to 90 days post-transplantation
Appendicular Lean Mass Index	To account for body size, ALM is divided by height squared	From enrollment to 90 days post-transplantation
Hand grip strength	Using a handheld electronical dynamometer	From enrollment to 90 days post-transplantation.
Lower limb strength	5-repetition Sit-to-stand Test	From enrollment to 90 days post-transplantation.
Lower limb strength and endurance	30-second Sit-to-stand Test	From enrollment to 90 days post-transplantation.
Leg Extensor Power	Measured using a Nottingham Power Rig,	From enrollment to 90 days post-transplantation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Habitual gait speed	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)	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	Daily steps	From enrollment to 90 days post-transplantation
Self reported physical activity	International Physical Activity Questionnaire short form (IPAQ-sf)	From enrollment to 90 days post-transplantation
Karnofsky Performance Status	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)	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)	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).	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	Days of hospitalization	From enrollment to 90 days and 1, 3 and 5 years after transplantation
Survival	All-course survival with-out progression or relapse	1, 3 and 5 years after transplantation
Interviews	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	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	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	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	Exercise habits rapported by International Physical Activity Questionnaire (IPAQ)	1,3 and 5 years after transplantation
Secondary malignancy	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 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	Days after transplantation with being independent of bloodtransfusions	From day 0 to day 90
Acute GvHD	Development of Acute GvHD	Development of > grade 2 Acute GvHD from day 0 to day 90

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2026
• Primary Completion (Estimated): January 12, 2028
• Study Completion (Estimated): October 12, 2032

Study Registration Dates

• First Submitted: December 10, 2025
• First Submitted That Met QC Criteria: January 6, 2026
• First Posted (Actual): January 14, 2026

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Exercise; Prehabilitation; resistance training; nutritional support
• Additional Relevant MeSH Terms: Behavior; Motor Activity; Health Care Quality, Access, and Evaluation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Investigative Techniques; Epidemiologic Methods; Therapeutics; Surgical Procedures, Operative; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Physical Therapy Modalities; Diet, Food, and Nutrition; Physiological Phenomena; Transplantation; Nutritional Physiological Phenomena; Patient Care; Health Services; Health Care Facilities Workforce and Services; Population Characteristics; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Nutrition Therapy; Health Status; Demography; Epidemiologic Measurements; Physical Conditioning, Human; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Stem Cell Transplantation; Perioperative Care; Exercise; Nutritional Status; Resistance Training; Hematopoietic Stem Cell Transplantation; Nutrition Assessment; Preoperative Exercise; Nutritional Support
• Other Study ID 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