Allogeneic Hematopoietic Stem Cell Transplantation Recipient
Conditions
Keywords
Prehabilitation, Exercise, resistance training, nutritional support
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.
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.
Interventions
OTHERResistance training
Structured and supervised, group-based, resistance training 3x per week (individually tailored to the individual's capabilities)
DIETARY_SUPPLEMENTNutritional Support
Optimized dietary counseling and supplementation to optimize nutritional intake
PROCEDUREUsual care
Usual care is the standard care before allogeneic hematopoietic stem cell transplantation
Sponsors
Rigshospitalet, Denmark
Aarhus University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes Assessor and statistician will be blinded
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | From enrollment to 90 days post-transplantation | 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
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization | From enrollment to 90 days post-transplantation | Days of hospitalization |
| Appendicular lean mass | From enrollment to 90 days post-transplantation | Measured using dual-energy X-ray absorptiometry (DXA) |
| Appendicular Lean Mass Index | From enrollment to 90 days post-transplantation | To account for body size, ALM is divided by height squared |
| Hand grip strength | From enrollment to 90 days post-transplantation. | Using a handheld electronical dynamometer |
| Lower limb strength | From enrollment to 90 days post-transplantation. | 5-repetition Sit-to-stand Test |
| Lower limb strength and endurance | From enrollment to 90 days post-transplantation. | 30-second Sit-to-stand Test |
| Leg Extensor Power | From enrollment to 90 days post-transplantation | Measured using a Nottingham Power Rig, |
Countries
Denmark
Contacts
CONTACTJan Christensen, PhD
Outcome results
None listed