Back to resultsStrength Training and ADLs in Childhood Leukemia and Lymphoma Patients
Primary Purpose
Childhood Cancer
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional supportive care trial for Childhood Cancer focused on measuring exercise, strength training, activities of daily living, childhood cancer, leukemia, Non-Hodgkin lymphoma
Eligibility Criteria
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.
Sites / Locations
- Kinderklinik München Schwabing TUM School of Medicine, Department of Pediatrics and Children's Cancer Research Center, Technical University of Munich
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Supervised exercise training including specific strength training tools and general exercise contents (standard care), 2-3 times per week, 30 minutes per session
Supervised exercise training regarding general exercise contents (standard care), 2-3 times per week, 30 min per session
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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 level of physical activity
Physical activity is assessed using an accelerometer (movisens) for the period of 7 days.
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.
Full Information
NCT ID
NCT03934060
First Posted
April 14, 2019
Last Updated
May 26, 2021
Sponsor
Technical University of Munich
1. Study Identification
Unique Protocol Identification Number
NCT03934060
Brief Title
Strength Training and ADLs in Childhood Leukemia and Lymphoma Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
February 25, 2021 (Actual)
Study Completion Date
February 25, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Technical University of Munich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Cancer
Keywords
exercise, strength training, activities of daily living, childhood cancer, leukemia, Non-Hodgkin lymphoma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Supervised exercise training including specific strength training tools and general exercise contents (standard care), 2-3 times per week, 30 minutes per session
Arm Title
Control
Arm Type
No Intervention
Arm Description
Supervised exercise training regarding general exercise contents (standard care), 2-3 times per week, 30 min per session
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
specific strength training
Primary Outcome Measure Information:
Title
Change of score of the Activities Scale for Kids - performance version
Description
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 Outcome Measure Information:
Title
Change of motor performance analyzed with the Motor performance test in Pediatiric Oncology (MOON)
Description
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
Title
Change of level of physical activity
Description
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
Title
Change in performance in a parkour in activities of daily living
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Kinderklinik München Schwabing TUM School of Medicine, Department of Pediatrics and Children's Cancer Research Center, Technical University of Munich
City
Munich
State/Province
Bavaria
ZIP/Postal Code
80804
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Strength Training and ADLs in Childhood Leukemia and Lymphoma Patients
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