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

NCT07341698 | Recruiting DMC

• 2 other identifiers: H-25053677MS25-01447
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Allogeneic Hematopoietic Stem Cell Transplantation Recipient

Keywords

Prehabilitation; Exercise; resistance training; nutritional support

Outcome Measures

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)

  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 Outcomes (7)

• Hospitalization

  From enrollment to 90 days post-transplantation

• Appendicular lean mass

  From enrollment to 90 days post-transplantation

• Appendicular Lean Mass Index

  From enrollment to 90 days post-transplantation

• Hand grip strength

  From enrollment to 90 days post-transplantation.

• Lower limb strength

  From enrollment to 90 days post-transplantation.

Other Outcomes (19)

• Habitual gait 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)

  From enrollment to 90 days post-transplantation

• Physical activity monitoring

  From enrollment to 90 days post-transplantation

Study Arms (2)

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.

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

Other: Resistance training; Dietary Supplement: Nutritional Support; Procedure: Usual care

Interventions

Resistance training OTHER

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

Also known as: Exercise, Prehabilitation

Usual care plus the prehabilitation intervention

Nutritional Support DIETARY_SUPPLEMENT

Optimized dietary counseling and supplementation to optimize nutritional intake

Also known as: Prehabilitation, dietary counseling, nutrition

Usual care plus the prehabilitation intervention

Usual care PROCEDURE

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

Also known as: HSCT, allogeneic hematopoietic stem cell transplantation, hematopoietic stem cell transplantation

Usual care; Usual care plus the prehabilitation intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Aarhus University Hospital: collaborator

Study Sites (1)

Copenhagen University Hospital - Rigshospitalet

Copenhagen, Denmark, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Motor Activity

Interventions

Resistance Training; Exercise; Preoperative Exercise; Nutritional Support; Nutrition Assessment; Nutritional Status; Hematopoietic Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Perioperative Care; Surgical Procedures, Operative; Health Services; Health Care Facilities Workforce and Services; Nutrition Therapy; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Transplantation

Central Study Contacts

Jan Christensen, PhD

CONTACT

+4522479075; jan.christensen.02@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessor and statistician will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher and Head of Research

Model Details: 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.

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: January 14, 2026
• Study Start: January 12, 2026
• Primary Completion (Estimated): January 12, 2028
• Study Completion (Estimated): October 12, 2032
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

DK (1)