Patient Activation, Counseling and Exercise - Acute Leukemia (PACE-AL)

Study Overview
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Brief Summary
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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.

Official Title
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Patient Activation, Counseling and Exercise - Acute Leukemia (PACE-AL) Health Promoting Rehabilitation. A Multimodal Exercise-based Intervention in Patients With Acute Leukaemia Undergoing Re-induction or Consolidation Chemotherapy

Conditions
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Acute Leukemia

Intervention / Treatment
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* Other: Exercise based multimodal intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise based multimodal intervention<br>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 | Other: Exercise based multimodal intervention<br>* 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.<br>|
| No Intervention: Control Group<br>Control group receives usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six Minute Walk Distance 6MWD | Change in distance in meter | Change from baseline in 6MWD at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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#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]