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

NCT ID: NCT07341698

Last Updated: 2026-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-12

Study Completion Date

2032-10-12

Brief Summary

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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

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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.

Conditions

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Allogeneic Hematopoietic Stem Cell Transplantation Recipient

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Outcomes Assessor and statistician will be blinded

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type PROCEDURE

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

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

Group Type EXPERIMENTAL

Resistance training

Intervention Type OTHER

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

Nutritional Support

Intervention Type DIETARY_SUPPLEMENT

Optimized dietary counseling and supplementation to optimize nutritional intake

Usual care

Intervention Type PROCEDURE

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

Interventions

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Resistance training

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

Intervention Type OTHER

Nutritional Support

Optimized dietary counseling and supplementation to optimize nutritional intake

Intervention Type DIETARY_SUPPLEMENT

Usual care

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

Intervention Type PROCEDURE

Other Intervention Names

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Exercise Prehabilitation Prehabilitation dietary counseling nutrition HSCT allogeneic hematopoietic stem cell transplantation hematopoietic stem cell transplantation

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Jan Christensen

Senior Researcher and Head of Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Copenhagen University Hospital - Rigshospitalet

Copenhagen, Denmark, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Jan Christensen, PhD

Role: CONTACT

+4522479075

Facility Contacts

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Magnus N Bech, PhD Student

Role: primary

+4535453484

Other Identifiers

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MS25-01447

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H-25053677

Identifier Type: -

Identifier Source: org_study_id

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