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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03934060
Other study ID # DJCLS 15 R/2016
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2017
Est. completion date February 25, 2021

Study information

Verified date May 2021
Source Technische Universität München
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date February 25, 2021
Est. primary completion date February 25, 2021
Accepts healthy volunteers No
Gender All
Age group 4 Years to 18 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise
specific strength training

Locations

Country Name City State
Germany Kinderklinik München Schwabing TUM School of Medicine, Department of Pediatrics and Children's Cancer Research Center, Technical University of Munich Munich Bavaria

Sponsors (1)

Lead Sponsor Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
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