Strength Training and ADLs in Childhood Leukemia and Lymphoma Patients

Childhood Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03934060
• Other study ID #: DJCLS 15 R/2016
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Childhood Cancer
• Leukemia
• Lymphoma

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