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| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
| Lundbeck Foundation | OTHER |
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The purpose of this pilot study is to test an exercise-based multidimensional intervention for patients with acute leukaemia undergoing consolidation chemotherapy in the context of outpatient management. Further, to test for safety, feasibility and preliminary effect on physical and functional capacity, and health related quality of life.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health counseling and exercise | Behavioral | The intervention is initiated during chemotherapy treatment (consolidation) in the outpatient clinic and continues for 6 weeks. The intervention is a three hour/wk supervised in-hospital programme of aerobic (stationary cycle) and functional muscle training, progressive relaxation training, nutrition supplement (protein and carbohydrate) immediately after training and two health-promoting counseling sessions - Further, patients are fitted with a step counter pedometer. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility - adherence rates | Percentage of intervention participation | Adherence to the intervention components from baseline to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Number and type of adverse events | baseline to 6 weeks |
| 6MWD | Change in distance in meter | Change from baseline in 6MWD at 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary Jarden, Ph.D. | Copenhagen University Hospital at Herlev | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen University Hospital | Copenhagen | Denmark | ||||
| Herlev Hospital |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D015470 | Leukemia, Myeloid, Acute |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Attrition | Number of patients that withdrew from the project | Withdrawal from the project from baseline to 6 weeks |
| Timed chair stand | Change in the number of repetitions | Change from baseline in timed chair stand at 6 weeks |
| Timed bicep curl | Change in number of repetitions | Change from baseline in timed bicep curl at 6 weeks |
| FACT-Anemia | Change in scores for quality of life/function | Change from baseline in FACT-An at 6 weeks |
| HADS | Change in scores for emotional wellbeing | Change from baseline in HADS at 6 weeks |
| SF36 | Change in scores for general health | Change from baseline in SF36 at 6 weeks |
| MDSAI | Change in scores for symptom burden | Change from baseline over time (1,2,3,4,5,6 weeks) |
| Herlev |
| Denmark |
| D009369 |
| Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |