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Completed

NCT Number: NCT03934060

Strength Training and ADLs in Childhood Leukemia and Lymphoma Patients

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).

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Key information

Conditions

Childhood Cancer Behavior Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Motor Activity Neoplasms Neoplasms by Histologic Type

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Munich, Bavaria, 80804, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise

Other

specific strength training

Primary outcomes

  1. Change of score of the Activities Scale for Kids - performance version

    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

    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).

Secondary outcomes

  1. Change of motor performance analyzed with the Motor performance test in Pediatiric Oncology (MOON)

    Time frame: Change of motor performance from baseline to 6 months

    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.

  2. Change of level of physical activity

    Time frame: Change of physical activity level from baseline to 3 months, from 3 to 6 months, from 6 to 12 months

    Physical activity is assessed using an accelerometer (movisens) for the period of 7 days.

  3. Change in performance in a parkour in activities of daily living

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

    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.

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
May 1, 2019
Registry last updated
May 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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