Childhood CancerNCT03934060
Strength Training and ADLs in Childhood Leukemia and Lymphoma Patients
A study testing Exercise in people with Childhood Cancer, run by Technical University of Munich at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Childhood Cancer
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2017to 25 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Kinderklinik München Schwabing TUM School of Medicine, Department of Pediatrics and Children's Cancer Research Center, Technical University of Munich
Munich, Bavaria, 80804
About this study
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
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).
- Conditions
- Childhood Cancer
- Being tested
- Exercise
- Keywords
- exercise, strength training, activities of daily living, childhood cancer, leukemia, Non-Hodgkin lymphoma
- Medical subject headings
- Neoplasms, Motor Activity, Leukemia, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
specific strength training
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Supervised exercise training including specific strength training tools and general exercise contents (standard care), 2-3 times per week, 30 minutes per session Receives: Other: Exercise |
| Control | No intervention | Supervised exercise training regarding general exercise contents (standard care), 2-3 times per week, 30 min per session |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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 outcomes (3)
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.
Measured: Change of motor performance from baseline to 6 months
Change of level of physical activity
Physical activity is assessed using an accelerometer (movisens) for the period of 7 days.
Measured: 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
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.
Measured: Change of score in the parkour from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start1 Sep 2017
- Primary completion25 Feb 2021
- Study completion25 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood CancerStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabine Kesting, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03934060
- Sponsor's protocol ID
- DJCLS 15 R/2016
- Status last verified
- May 2021
- First submitted
- 14 Apr 2019
- Last updated
- 27 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03934060
- Acronym / sponsor ID
- DJCLS 15 R/2016
- Conditions
- Childhood Cancer
- Keywords
- exercise, strength training, activities of daily living, childhood cancer, leukemia, Non-Hodgkin lymphoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 25 Feb 2021 (actual)
- Study completion
- 25 Feb 2021 (actual)
- First posted
- 1 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: ExerciseSupervised exercise training including specific strength training tools and general exercise contents (standard care), 2-3 times per week, 30 minutes per session |
| Control | No intervention | –Supervised exercise training regarding general exercise contents (standard care), 2-3 times per week, 30 min per session |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercisespecific strength training | Other | Intervention |
Primary outcome
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).
3 secondary outcomes
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
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
Change in performance in a parkour in activities of daily living
Time frame: Change of score in the parkour from baseline to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Childhood Cancer, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2021.