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| ID | Type | Description | Link |
|---|---|---|---|
| MS25-01447 | Other Grant/Funding Number | Danish Cancer Society |
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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | Active Comparator | 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. |
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| Usual care plus the prehabilitation intervention | Experimental | The prehabilitation group will in addition to usual care receive supervised individually tailored resistance training and optimized nutritional support |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resistance training | Other | Structured and supervised, group-based, resistance training 3x per week (individually tailored to the individual's capabilities) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to 90 days post-transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalization | Days of hospitalization | From enrollment to 90 days post-transplantation |
| Appendicular lean mass | Measured using dual-energy X-ray absorptiometry (DXA) |
| Measure | Description | Time Frame |
|---|---|---|
| Habitual gait speed | 10-Meter walk test: Time to walk 10 meter distance at a preferred speed | 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) |
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jan Christensen, PhD | Contact | +4522479075 | jan.christensen.02@regionh.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen University Hospital - Rigshospitalet | Recruiting | Copenhagen | Denmark | 2100 | Denmark |
The investigators have agree to make data and materials supporting the results and analyses available upon reasonable request
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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.
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Outcomes Assessor and statistician will be blinded
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| Nutritional Support | Dietary Supplement | Optimized dietary counseling and supplementation to optimize nutritional intake |
|
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| Usual care | Procedure | Usual care is the standard care before allogeneic hematopoietic stem cell transplantation |
|
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| From enrollment to 90 days post-transplantation |
| Appendicular Lean Mass Index | To account for body size, ALM is divided by height squared | From enrollment to 90 days post-transplantation |
| Hand grip strength | Using a handheld electronical dynamometer | From enrollment to 90 days post-transplantation. |
| Lower limb strength | 5-repetition Sit-to-stand Test | From enrollment to 90 days post-transplantation. |
| Lower limb strength and endurance | 30-second Sit-to-stand Test | From enrollment to 90 days post-transplantation. |
| Leg Extensor Power | Measured using a Nottingham Power Rig, | From enrollment to 90 days post-transplantation |
Moderate to Vigorous Physical Activity (MVPA) will be measured with algorithms from the use of SENS motion wearables |
| From enrollment to 90 days post-transplantation |
| Physical activity monitoring | Daily steps | From enrollment to 90 days post-transplantation |
| Self reported physical activity | International Physical Activity Questionnaire short form (IPAQ-sf) | 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. | 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. | 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. | 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. | From enrollment to 90 days post-transplantation |
| Days of hospitalization | Days of hospitalization | From enrollment to 90 days and 1, 3 and 5 years after transplantation |
| Survival | All-course survival with-out progression or relapse | 1, 3 and 5 years after transplantation |
| Interviews | Participants will be asked to participate in interviews during the study period | 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. | 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 | 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 | 1,3 and 5 years after transplantation |
| Exercise habits | Exercise habits rapported by International Physical Activity Questionnaire (IPAQ) | 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. | 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 | From enrollment to 90 days after transplantation |
| Transfusion need | Days after transplantation with being independent of bloodtransfusions | From day 0 to day 90 |
| Acute GvHD | Development of Acute GvHD | Development of > grade 2 Acute GvHD from day 0 to day 90 |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| D015444 | Exercise |
| D000082622 | Preoperative Exercise |
| D018529 | Nutritional Support |
| D015596 | Nutrition Assessment |
| D009752 | Nutritional Status |
| D018380 | Hematopoietic Stem Cell Transplantation |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D019990 | Perioperative Care |
| D013514 | Surgical Procedures, Operative |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D044623 | Nutrition Therapy |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D006304 | Health Status |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D014180 | Transplantation |
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