Strength Training and ADLs in Childhood Leukemia and Lymphoma Patients

Study Overview
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Brief Summary
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Reduced activity levels and reduced muscular strength could severely impair the activities of daily living (ADLs) in pediatric leukemia and Non-Hodgkin lymphoma patients. Increased muscle strength is associated with improved accomplishment of ADLs and consequently greatest possible normality, autonomy and mobility. Primary outcome of this RCT (n=20/20) is the analysis of effects of a treatment-associated and close to every day life strength training (2-3 times/week) compared to a general exercise program (standard care).

Official Title
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Effects of a Specific Strength Training Regarding Activities of Daily Living (ADLs) Associated With Movement During Treatment of Leukemia or Non-Hodgkin Lymphoma in Childhood and Adolescence

Conditions
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Childhood Cancer

Intervention / Treatment
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* Other: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with Acute Leukemia or Non-Hodgkin Lymphoma Diagnosed and/or treated at the Kinderklinik München Schwabing, Technische Universität München Informed consent as documented by signature Exclusion Criteria: Medical contraindications regarding strength training (e.g. risk of bleeding, ...) Contraindications to one of the inclusion criteria mentioned above Inability to follow the procedures and understand the intervention and assessments of this study, e.g. due to cognitive impairment, language problems, psychological disorders etc.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Supervised exercise training including specific strength training tools and general exercise contents (standard care), 2-3 times per week, 30 minutes per session | Other: Exercise<br>* specific strength training<br>|
| No Intervention: Control<br>Supervised exercise training regarding general exercise contents (standard care), 2-3 times per week, 30 min per session | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of score of the Activities Scale for Kids - performance version | The ASK - Activities Scale for Kids performance version by NL Young assesses an overall summary score (0-100) of self-reported activities of daily living in children and adolescents. The scale monitors changes associated with therapeutic interventions. Higher values represent a better outcome. The ASK contains 30 items in 7 sub-domains (personal care, dressing, other skills, locomotion, play, standing skills and transfer). | Change of the ASK score from baseline to 3 months, change from 3 months to 6 months, change from 6 months to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of motor performance analyzed with the Motor performance test in Pediatiric Oncology (MOON) | Motor performance is assessed by the MOON-test, a tool to examine motor performance abilities in children and adolescents during and after cancer treatment. There's no summary score; reference values of healthy children enable comparison of the tested children. | Change of motor performance from baseline to 6 months | 
| Change of level of physical activity | Physical activity is assessed using an accelerometer (movisens) for the period of 7 days. | Change of physical activity level from baseline to 3 months, from 3 to 6 months, from 6 to 12 months | 
| Change in performance in a parkour in activities of daily living | A standardized parkour with tasks imitating activities of daily living is used to objectively verify the ASK score. Points from 0-4 are counted for each task depending on quality of movement (0 = task can not be completed, 1 = task can be completed with help, 2 = task can be completed with several attempts, 3 = task can be completed with only little effort, 4 = task can be completed without any problems or effort). There are no reference values for the parkour, but intra-individual changes are analyzed. | Change of score in the parkour from baseline to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, strength training, activities of daily living, childhood cancer, leukemia, Non-Hodgkin lymphoma