Strength Training and ADLs in Childhood Leukemia and Lymphoma Patients

May 26, 2021 updated by: Sabine Kesting, Technical University of Munich

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 80804
        • Kinderklinik München Schwabing TUM School of Medicine, Department of Pediatrics and Children's Cancer Research Center, Technical University of Munich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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
specific strength training
No Intervention: Control
Supervised exercise training regarding general exercise contents (standard care), 2-3 times per week, 30 min per session

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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)
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.
Change of motor performance from baseline to 6 months
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.
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
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.
Change of score in the parkour from baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Actual)

February 25, 2021

Study Completion (Actual)

February 25, 2021

Study Registration Dates

First Submitted

April 14, 2019

First Submitted That Met QC Criteria

April 28, 2019

First Posted (Actual)

May 1, 2019

Study Record Updates

Last Update Posted (Actual)

May 27, 2021

Last Update Submitted That Met QC Criteria

May 26, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DJCLS 15 R/2016

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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