Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
| Novo Nordisk A/S | INDUSTRY |
| Danish Cancer Society | OTHER |
| Lundbeck Foundation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to test a new preventive and restorative intervention for patients with acute leukaemia undergoing consolidation chemotherapy, to measure and delineate the patients' treatment related symptom burden and to explore the effect of the intervention on length of hospital stay, duration of sick leave and return to work status. Further, to examine the relationship of the symptom profile with clinical indicators, physiological response, physical performance and survival.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise based multimodal intervention | Experimental | The intervention is initiated early, during treatment (consolidation) in the intra-hospital setting and continues for two successive treatment series (12 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 health-promoting consultation combined with an unsupervised in-home walking and progressive relaxation programme |
|
| Control Group | No Intervention | Control group receives usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise based multimodal intervention | Other | The intervention is initiated early, during treatment (consolidation) in the intra-hospital setting and continues for two successive treatment series (12 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 health-promoting consultation combined with an unsupervised in-home walking and progressive relaxation programme. |
| Measure | Description | Time Frame |
|---|---|---|
| Six Minute Walk Distance 6MWD | Change in distance in meter | Change from baseline in 6MWD at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Estimated VO2 max Aastrand test | Change in l/m | Change from baseline in VO2 Aastrand test at 12 weeks |
| Timed chair stand | Change in number of repetitions |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mary Jarden, Ph.D. | UCSF and CIRE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen University Hospital Rigshospital | Copenhagen | DK 2100 | Denmark | |||
| Herlev Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27036163 | Derived | Jarden M, Moller T, Christensen KB, Kjeldsen L, Birgens HS, Adamsen L. Multimodal intervention integrated into the clinical management of acute leukemia improves physical function and quality of life during consolidation chemotherapy: a randomized trial 'PACE-AL'. Haematologica. 2016 Jul;101(7):e316-9. doi: 10.3324/haematol.2015.140152. Epub 2016 Apr 1. No abstract available. | |
| 24083543 |
Not provided
Not provided
Not provided
| OTHER |
Not provided
Not provided
Not provided
Not provided
|
| Change from baseline in timed chair stand at 12 weeks |
| Timed biceps curl | Change in number of repetitions | Change from baseline in timed bicep curl at 12 weeks |
| EORTC QLQ-C30 | Change in scores for quality of life | Change from baseline in EORTC QLQ-C30 at 12 weeks |
| FACT-An | Change in scores for quality of life/function | Change from baseline in FACT-An at 12 weeks |
| HADS | Change in scores for emotional wellbeing | Change from baseline in HADS at 12 weeks |
| SF36 | Change in scores for general health | Change from baseline in SF36 at 12 weeks |
| MDASI | Change in scores for symptom burden | Change from baseline over time (1,2,3,4,5,6,7,8,9,10,11,12 weeks) |
| Herlev |
| DK 2730 |
| Denmark |
| Derived |
| Jarden M, Moller T, Kjeldsen L, Birgens H, Christensen JF, Bang Christensen K, Diderichsen F, Hendriksen C, Adamsen L. Patient Activation through Counseling and Exercise--Acute Leukemia (PACE-AL)--a randomized controlled trial. BMC Cancer. 2013 Oct 2;13:446. doi: 10.1186/1471-2407-13-446. |