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 volunteersQualifiers
None
Disqualifiers
pregnancy
physical or mental disabilities precluding test of muscle function
inability to read and understand Danish or English
Trial design
Parallel
Treatments tested in this trial
Resistance training
Other interventionStructured and supervised, group-based, resistance training 3x per week (individually tailored to the individual's capabilities)
Nutritional Support
Dietary supplementOptimized dietary counseling and supplementation to optimize nutritional intake
Usual care
Procedure/SurgeryUsual care is the standard care before allogeneic hematopoietic stem cell transplantation
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Hospitalization
Days of hospitalization
Appendicular lean mass
Measured using dual-energy X-ray absorptiometry (DXA)
Appendicular Lean Mass Index
To account for body size, ALM is divided by height squared
Hand grip strength
Using a handheld electronical dynamometer
Other outcomes
Habitual gait speed
10-Meter walk test: Time to walk 10 meter distance at a preferred speed
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
Physical activity monitoring
Daily steps
Self reported physical activity
International Physical Activity Questionnaire short form (IPAQ-sf)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Rigshospitalet, Denmark
Lead sponsor
Aarhus University Hospital
Collaborator