Childhood CancerNCT05235633
ADLs at the End of Acute Treatment for Childhood Leukemia and Non-Hodgkin Lymphoma
An observational study of 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?
- Assessment of the accomplishment regarding Activities of Daily Living at the end of acute treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 19 Apr 2022to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: The study polulation will be recruited at the Oncology and Hematology Day Hospital at the Dr. von Hauner Children's Hospital of the University of Munich.
Who may be able to join
- Children and adolescents aged 4-18 years
- At the end of acute treament for leukemia or non-Hodgkin lymphoma
- Diagnosed and/or treated at the Dr. von Hauner Children's Hospital, University of Munich
- Informed consent as documented by signature
Who cannot join
- Medical contraindication to perform this unique test battery (e.g., acute bleeding risk, pain, nausea, acute orthopedic impairments)
- Inability to follow study procedures (e.g., language problems, mental retardation)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
Kinderklinik München Schwabing, TUM School of Medicine, Department of Paediatrics and Children's Cancer Research Center, Technical University of Munich, Germany
Munich, 80804
About this study
Official title: Activities of Daily Living at the End of Acute Treatment for Acute Leukemia or Non-Hodgkin Lymphona During 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. This associated investigation to the study with the ClinicalTrials.gov Identifier NCT03934060 aims at collecting data in a comparison cohort with respect to ADLs in children and adolescents who did not receive a standardized strenght training intervention during the whole course of treatment.
- Conditions
- Childhood Cancer
- Being tested
- Assessment of the accomplishment regarding Activities of Daily Living at the end of acute treatment
- Keywords
- Activities of daily living, Leukemia, Non-Hodgkin Lymphoma, Physical activity, Motor performance
- Medical subject headings
- Neoplasms, Leukemia, Lymphoma, Non-Hodgkin, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of the accomplishment regarding Activities of Daily Living at the end of acute treatmentDiagnostic test
Participants perform a test battery to assess the capability to accomplish Activities of Daily Living that includes a standardized and validated questionnaire, a parcour with tasks based on Activities of Daily Living and a motor performance test.
| Study group | Role | What they receive |
|---|---|---|
| Comparison cohort | Children and adolescents at the end of acute treatment for leukemia and non-Hodgkin lymphoma without any exercise intervention Receives: Diagnostic Test: Assessment of the accomplishment regarding Activities of Daily Living at the end of acute treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 and the current status of accomplishment of activities of daily living. 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: During the procedure
Secondary outcomes (2)
Motor Performance
Motor performance is assessed by the MOON-test (Motor performance test in Pediatiric Oncology), 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: During the procedure
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: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start19 Apr 2022
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich
- Responsible party
- Principal investigator, Sabine Kesting, Technical University of Munich
- Investigators
- Sabine Kesting, Principal investigator, Kinderklinik München Schwabing TUM School of Medicine, Department of Pediatrics and Children's Cancer Research Center, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05235633
- Sponsor's protocol ID
- ADL Comparison Cohort
- Status last verified
- Aug 2026
- First submitted
- 11 Jan 2022
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activities of Daily Living at the End of Acute Treatment for Acute Leukemia or Non-Hodgkin Lymphona During Childhood and Adolescence
- ClinicalTrials.gov ID
- NCT05235633
- Acronym / sponsor ID
- ADL Comparison Cohort
- Conditions
- Childhood Cancer
- Keywords
- Activities of daily living, Leukemia, Non-Hodgkin Lymphoma, Physical activity, Motor performance
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Feb 2022 (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. This associated investigation to the study with the ClinicalTrials.gov Identifier NCT03934060 aims at collecting data in a comparison cohort with respect to ADLs in children and adolescents who did not receive a standardized strenght training intervention during the whole course of treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Comparison cohort | – | Diagnostic Test: Assessment of the accomplishment regarding Activities of Daily Living at the end of acute treatmentChildren and adolescents at the end of acute treatment for leukemia and non-Hodgkin lymphoma without any exercise intervention |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study polulation will be recruited at the Oncology and Hematology Day Hospital at the Dr. von Hauner Children's Hospital of the University of Munich.
Key inclusion criteria (4 listed)
- Children and adolescents aged 4-18 years
- At the end of acute treament for leukemia or non-Hodgkin lymphoma
- Diagnosed and/or treated at the Dr. von Hauner Children's Hospital, University of Munich
- Informed consent as documented by signature
Key exclusion criteria (2 listed)
- Medical contraindication to perform this unique test battery (e.g., acute bleeding risk, pain, nausea, acute orthopedic impairments)
- Inability to follow study procedures (e.g., language problems, mental retardation)
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 |
|---|---|---|
| Assessment of the accomplishment regarding Activities of Daily Living at the end of acute treatmentParticipants perform a test battery to assess the capability to accomplish Activities of Daily Living that includes a standardized and validated questionnaire, a parcour with tasks based on Activities of Daily Living and a motor performance test. | Diagnostic test | Comparison cohort |
Primary outcome
Score of the Activities Scale for Kids - performance version
Time frame: During the procedure
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 and the current status of accomplishment of activities of daily living. 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).
2 secondary outcomes
Motor Performance
Time frame: During the procedure
Performance in a Parkour in Activities of Daily Living
Time frame: During the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Sabine Kesting principal investigator
Kinderklinik München Schwabing TUM School of Medicine, Department of Pediatrics and Children's Cancer Research Center, Technical University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 4 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 19 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Score of the Activities Scale for Kids - performance version (time frame: During the procedure). 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 19 Aug 2026.