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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRigshospitalet, Denmark

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

pregnancy

physical or mental disabilities precluding test of muscle function

inability to read and understand Danish or English

Trial design

Design model

Parallel

Treatments tested in this trial

  • Resistance training

    Other intervention

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

  • Nutritional Support

    Dietary supplement

    Optimized dietary counseling and supplementation to optimize nutritional intake

  • Usual care

    Procedure/Surgery

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

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Usual careActive comparator 1 intervention
Group B: Usual care plus the prehabilitation interventionExperimental treatment 3 interventions

Trial outcomes

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.

Time frame
From enrollment to 90 days post-transplantation

Secondary outcomes

1

Hospitalization

Days of hospitalization

Time frame
From enrollment to 90 days post-transplantation
2

Appendicular lean mass

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

Time frame
From enrollment to 90 days post-transplantation
3

Appendicular Lean Mass Index

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

Time frame
From enrollment to 90 days post-transplantation
4

Hand grip strength

Using a handheld electronical dynamometer

Time frame
From enrollment to 90 days post-transplantation.

Other outcomes

1

Habitual gait speed

10-Meter walk test: Time to walk 10 meter distance at a preferred speed

Time frame
From enrollment to 90 days post transplantation
2

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

Time frame
From enrollment to 90 days post-transplantation
3

Physical activity monitoring

Daily steps

Time frame
From enrollment to 90 days post-transplantation
4

Self reported physical activity

International Physical Activity Questionnaire short form (IPAQ-sf)

Time frame
From enrollment to 90 days post-transplantation

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rigshospitalet, Denmark

Lead sponsor

Aarhus University Hospital

Collaborator