Health Counseling and Exercise in Patients With Acute Leukemia - Pilot Study

Study Overview
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Brief Summary
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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.

Official Title
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Patient Activation Through Counseling and Exercise - Acute Leukemia - Pilot Trial

Conditions
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Acute Leukemia

Intervention / Treatment
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* Behavioral: Health counseling and exercise


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 cardiac disease within the last three months. Documented bone metastasis Dementia, psychotic Cannot write or read 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Health counseling and exercise|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility - adherence rates | Percentage of intervention participation | Adherence to the intervention components from baseline to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer Related fatigue, Quality of Life, Psychosocial Intervention, Rehabilitation, Physical Fitness, Physical Activity, Exercise Therapy, Exercise, Hematologic, Hematological, Leukemia, Myeloid, Acute, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Acute Leukemia