An interventional study of Resistance training and Nutritional Support in Allogeneic Hematopoietic Stem Cell Transplantation Recipient, sponsored by Rigshospitalet, Denmark. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-29.
Sponsored by Rigshospitalet, Denmark · Not applicable, Interventional, and Treatment
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.
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.
2,426 studies on the registry are indexed under Motor Activity; 1,161 are open to participants now.
This study's planned enrollment of 110 is above the median of 60 across 2,118 interventional studies indexed under Motor Activity.
Browse Motor Activity studies →Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
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
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
Structured and supervised, group-based, resistance training 3x per week (individually tailored to the individual's capabilities)
Also known as: Exercise, Prehabilitation
Optimized dietary counseling and supplementation to optimize nutritional intake
Also known as: Prehabilitation, dietary counseling, nutrition
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
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
Hospitalization
Days of hospitalization
Time frame: From enrollment to 90 days post-transplantation
Appendicular lean mass
Measured using dual-energy X-ray absorptiometry (DXA)
Time frame: From enrollment to 90 days post-transplantation
Appendicular Lean Mass Index
To account for body size, ALM is divided by height squared
Time frame: From enrollment to 90 days post-transplantation
Hand grip strength
Using a handheld electronical dynamometer
Time frame: From enrollment to 90 days post-transplantation.
Lower limb strength
5-repetition Sit-to-stand Test
Time frame: From enrollment to 90 days post-transplantation.
Lower limb strength and endurance
30-second Sit-to-stand Test
Time frame: From enrollment to 90 days post-transplantation.
Leg Extensor Power
Measured using a Nottingham Power Rig,
Time frame: From enrollment to 90 days post-transplantation
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
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
Physical activity monitoring
Daily steps
Time frame: From enrollment to 90 days post-transplantation
Self reported physical activity
International Physical Activity Questionnaire short form (IPAQ-sf)
Time frame: From enrollment to 90 days post-transplantation
Karnofsky Performance Status
Changes in Karnofsky Performance Status. Minimum value is 0 and maximum value is 100. A score of 100 equals normal function in performing daily activities while a score of 0 is equal to death. Thus, the lower scores the poorer performance of daily activities.
Time frame: From enrollment to 90 days after transplantation
Symptoms of anxiety using Hospital Anxiety and Depression Scale (HADS)
Symptoms of anxiety measured using HADS. The item is separated in two parts. One is scoring anxiety level and one is scoring depression level. The minimum value is 0 while the maximum for each scale is 21 for each scale (21 for anxiety and 21 for depression). The higher score the more severe symptoms of either anxiety or depression. Scores above 11 in each category is considered to be moderate to severe symptoms with action needed to be taken on the condition.
Time frame: From enrollment to 90 days post-transplantation
Symptoms of depression using Hospital Anxiety and Depression Scale (HADS)
Symptoms of depression measured using HADS. Symptoms of anxiety measured using HADS. The item is separated in two parts. One is scoring anxiety level and one is scoring depression level. The minimum value is 0 while the maximum for each scale is 21 for each scale (21 for anxiety and 21 for depression). The higher score the more severe symptoms of either anxiety or depression. Scores above 11 in each category is considered to be moderate to severe symptoms with action needed to be taken on the condition.
Time frame: From enrollment to 90 days post-transplantation
Health literacy mesured using the Health Literacy Questionnaire (HLQ).
Health literacy was assessed using the Health Literacy Questionnaire (HLQ). The HLQ comprises nine independent scales scored as the mean of their constituent items. Scales 1-5 are scored from 1 to 4, and scales 6-9 from 1 to 5, with higher scores indicating better health literacy.
Time frame: From enrollment to 90 days post-transplantation
Days of hospitalization
Days of hospitalization
Time frame: From enrollment to 90 days and 1, 3 and 5 years after transplantation
Survival
All-course survival with-out progression or relapse
Time frame: 1, 3 and 5 years after transplantation
Interviews
Participants will be asked to participate in interviews during the study period
Time frame: Participants will be asked to participate in interviews at time for recruitment (6-8 weeks before transplantation), at end of interventionperiod (day -7 to 0 before transplantation) and after last follow-up tests at day +90 after transplantation.
Complete remission
Complete remission objective measured and evaluated by responsible physician. Complete remission is defined as full donor dhimerism if \>95 % of bone marrow cells measured from chimerism is from donor.
Time frame: at day +90 and 1,3 and 5 years after transplantation
Cancer Progression
Progression of the underlying hematologic malignancy will be defined as objective worsening of disease burden after transplantation among patients who have not achieved complete remission after HSCT
Time frame: At 1, 3 and 5 years after transplantation
Cancer recurrence
Recurrence (relapse) will be defined as reappearance of the original hematologic malignancy in a patient who has previously achieved complete remission after HSCT
Time frame: 1,3 and 5 years after transplantation
Exercise habits
Exercise habits rapported by International Physical Activity Questionnaire (IPAQ)
Time frame: 1,3 and 5 years after transplantation
Secondary malignancy
Secondary malignancy will be defined as the occurrence of any new hematologic or solid malignant disease after HSCT that is genetically or clinically distinct from the primary malignancy for which the transplant was performed.
Time frame: At 1, 3 and 5 years after transplantation
Engraftment
Time from transplantation to first of three following days with absolute neutrophiles \>0,5 x10\^9 /L
Time frame: From enrollment to 90 days after transplantation
Transfusion need
Days after transplantation with being independent of bloodtransfusions
Time frame: From day 0 to day 90
Acute GvHD
Development of Acute GvHD
Time frame: Development of > grade 2 Acute GvHD from day 0 to day 90
Plan to share: Yes — The investigators have agree to make data and materials supporting the results and analyses available upon reasonable request
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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Rigshospitalet, Denmark