Acute Leukemia
Conditions
Keywords
#14 Cancer Related fatigue, #13 Quality of Life, #12 Psychosocial Intervention[ti/ab], #11 Rehabilitation[tw], #10 Physical Fitness[tw], #9 Physical Activity[tw], #8 Exercise Therapy[tw], #7 Exercise[tw], #6 Hematologic[tw], #5 Hematological[tw], #4 Leukemia, Myeloid, Acute[mh], #3 Acute Myeloid Leukemia[tw], #2 Acute Lymphoblastic Leukemia[tw], #1 Acute Leukemia[tw]
Brief summary
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.
Interventions
OTHERExercise based multimodal intervention
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.
Sponsors
University of Copenhagen
Novo Nordisk A/S
Danish Cancer Society
Lundbeck Foundation
Universitetshospitalernes Center for Sygepleje
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients that are able to speak Danish \> 18 years and newly diagnosed with acute leukæmia (MDS, AML, CMML, APL or ALL) * Normal EKG, blood pressure and pulse * Signed informed written consent
Exclusion criteria
* Medical reason that contraindicates physical activity * Patients diagnosed with a symptomatic cardial disease * Documented bone metastasis * Cognitively or emotionally unstable * Unable to read or write in Danish * Patients unable to carry out baseline tests
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Six Minute Walk Distance 6MWD | Change from baseline in 6MWD at 12 weeks | Change in distance in meter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Timed chair stand | Change from baseline in timed chair stand at 12 weeks | Change in number of repetitions |
| Timed biceps curl | Change from baseline in timed bicep curl at 12 weeks | Change in number of repetitions |
| EORTC QLQ-C30 | Change from baseline in EORTC QLQ-C30 at 12 weeks | Change in scores for quality of life |
| Estimated VO2 max Aastrand test | Change from baseline in VO2 Aastrand test at 12 weeks | Change in l/m |
| HADS | Change from baseline in HADS at 12 weeks | Change in scores for emotional wellbeing |
| SF36 | Change from baseline in SF36 at 12 weeks | Change in scores for general health |
| MDASI | Change from baseline over time (1,2,3,4,5,6,7,8,9,10,11,12 weeks) | Change in scores for symptom burden |
| FACT-An | Change from baseline in FACT-An at 12 weeks | Change in scores for quality of life/function |
Countries
Denmark
Outcome results
None listed