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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
| 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 :
- 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 :
- 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.
Eligibility Criteria
| 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
| 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 |
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).
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
|
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| 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 |
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| Condition ICMJE | Childhood Cancer | ||||
| Intervention ICMJE | Other: Exercise
specific strength training
|
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
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:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
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| 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 |
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| 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 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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