Strength Training and ADLs in Childhood Leukemia and Lymphoma Patients

Technical University of Munich40 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Childhood Cancer

Interventions

ExerciseOTHER

specific strength training

Eligibility

Sex: ALLMin age: 4 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Kinderklinik München Schwabing TUM School of Medicine, Department of Pediatrics and Children's Cancer Research Center, Technical University of Munich

Munich, Bavaria, Germany

Outcomes

Primary Outcomes

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).

Time frame: 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 Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Change of score in the parkour from baseline to 6 months

Data from ClinicalTrials.gov

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