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出境医 / 临床实验 / Strength Training and ADLs in Childhood Leukemia and Lymphoma Patients

Strength Training and ADLs in Childhood Leukemia and Lymphoma Patients

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).

Condition or disease Intervention/treatment Phase
Childhood Cancer Other: Exercise Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : February 25, 2021
Actual Study Completion Date : February 25, 2021
Arms and Interventions
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
Outcome Measures
Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Locations
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Germany
Kinderklinik München Schwabing TUM School of Medicine, Department of Pediatrics and Children's Cancer Research Center, Technical University of Munich
Munich, Bavaria, Germany, 80804
Sponsors and Collaborators
Technische Universität München
Tracking Information
First Submitted Date  ICMJE April 14, 2019
First Posted Date  ICMJE May 1, 2019
Last Update Posted Date May 27, 2021
Actual Study Start Date  ICMJE September 1, 2017
Actual Primary Completion Date February 25, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2019) 		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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2019)
  • 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 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 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Strength Training and ADLs in Childhood Leukemia and Lymphoma Patients
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Childhood Cancer
Intervention  ICMJE Other: Exercise
specific strength training
Study Arms  ICMJE
  • 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
    Intervention: Other: Exercise
  • No Intervention: Control
    Supervised exercise training regarding general exercise contents (standard care), 2-3 times per week, 30 min per session
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 28, 2019) 		40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 25, 2021
Actual Primary Completion Date February 25, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03934060
Other Study ID Numbers  ICMJE DJCLS 15 R/2016
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sabine Kesting, Technische Universität München
Study Sponsor  ICMJE Technische Universität München
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Technische Universität München
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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