Pediatric OncologyMUCKINCT02612025
Effects of Resistance and Endurance Training in Pediatric Cancer Patients During Intensive Treatment Phase
A study testing Exercise Training in people with Pediatric Oncology, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether combined endurance and resistance training can improve muscle strength in children and adolescents with cancer during the intensive treatment phase. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Pediatric Oncology
- What is being tested?
- Exercise Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2015to Sep 2018
- 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
- Malignant Tumor
- Medical Treatment in the Center for Pediatrics, Hematology, Oncology and Hemostaseology Mainz (Germany)
- > 3 years
- Signed Informed Consent
Who cannot join
- Functional and/or cognitive limitations which limit performance during training
- Orthopedic condition which hinders to adequately participate in exercise training
- Heart failure (NYHA III-IV)
- Partial or global respiratory failure
- Symptomatic coronary disease
- Serious therapy-refractory hypertonia
Show all 11Show fewer
- Sustainable thrombocytopenia <10.000/µl, f. ex. therapy-refractory autoimmune thrombocytopenia
- Hereditary or acquired thrombocytopenia or coagulation disturbance
- Uncontrolled cerebral spasm
- CNS metastases
- Medical or psychological condition which does in the doctors opinion not allow participation in sport activity
Trial locations and contacts
1 site in 1 country.
Germany1 site
Johannes-Gutenberg-University
Mainz, Rhineland-Palatinate, 55131
About this study
Official title: Effects of Combined Resistance and Endurance Training in Pediatric Cancer Patients During Intensive Treatment Phase
The purpose of this study is to determine whether combined endurance and resistance training can improve muscle strength in children and adolescents with cancer during the intensive treatment phase.
- Conditions
- Pediatric Oncology
- Being tested
- Exercise Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise TrainingBehavioural
Exercise training during intensive medical treatment. Training mainly composed of endurance and resistance exercises. 3 to 5 times per week for six weeks.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Exercise training during intensive medical treatment Receives: Behavioral: Exercise Training |
| Control group | No intervention | Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength: lower limb
Lower limb muscle strength measured by the load (kg) sustained in one repetition maximum test
Measured: Six weeks (pre-post intervention)
Secondary outcomes (7)
Muscle strength: upper limb
Upper limb muscle strength measured by the load (kg) sustained in one repetition maximum test
Measured: Six weeks (pre-post intervention)
Biomarker in Blood
Immune status and metabolic status
Measured: At the beginning of the intervention and three and six weeks after the beginning. Comparing the two time points inbetween study groups
Body composition
Bioelectrical Impedance Analysis
Measured: Six weeks (pre-post intervention)
Six-minute-walk performance
Measured: Six weeks (pre-post intervention)
Fatigue
Pediatric Quality of Life Inventory (PedsQL) Multidimensional Fatigue Scale
Measured: six weeks (pre-post intervention)
Quality of Life
KINDL: health related quality of life questionnaire
Measured: Six weeks (pre-post intervention)
Cardiorespiratory performance
Ergospirometry
Measured: Six weeks (pre-post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pediatric OncologyStudies of the same condition, open and under way.
- 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Univ.Prof.Dr.med. Joerg Faber, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02612025
- Sponsor's protocol ID
- Mucki01
- Acronym
- MUCKI
- Status last verified
- Mar 2019
- First submitted
- 17 Nov 2015
- Last updated
- 4 Mar 2019
- Results posted
- No
Publications
Winker M, Stossel S, Neu MA, Lehmann N, El Malki K, Paret C, Joisten N, Bloch W, Zimmer P, Faber J. Exercise reduces systemic immune inflammation index (SII) in childhood cancer patients. Support Care Cancer. 2022 Apr;30(4):2905-2908. doi: 10.1007/s00520-021-06719-3. Epub 2021 Dec 3.
PubMed 34860287Stossel S, Neu MA, Wingerter A, Bloch W, Zimmer P, Paret C, Malki KE, Baumann FT, Russo A, Henninger N, Lehmann N, Otto H, Faber J. Benefits of Exercise Training for Children and Adolescents Undergoing Cancer Treatment: Results From the Randomized Controlled MUCKI Trial. Front Pediatr. 2020 Jun 5;8:243. doi: 10.3389/fped.2020.00243. eCollection 2020.
PubMed 32582585
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combined Resistance and Endurance Training in Pediatric Cancer Patients During Intensive Treatment Phase
- ClinicalTrials.gov ID
- NCT02612025
- Acronym / sponsor ID
- MUCKI / Mucki01
- Conditions
- Pediatric Oncology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 23 Nov 2015 (estimated)
- 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.
The purpose of this study is to determine whether combined endurance and resistance training can improve muscle strength in children and adolescents with cancer during the intensive treatment phase.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Behavioral: Exercise TrainingExercise training during intensive medical treatment |
| Control group | No intervention | –Usual Care |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Malignant Tumor
- Medical Treatment in the Center for Pediatrics, Hematology, Oncology and Hemostaseology Mainz (Germany)
- > 3 years
- Signed Informed Consent
Key exclusion criteria (11 listed)
- Functional and/or cognitive limitations which limit performance during training
- Orthopedic condition which hinders to adequately participate in exercise training
- Heart failure (NYHA III-IV)
- Partial or global respiratory failure
- Symptomatic coronary disease
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 |
|---|---|---|
| Exercise TrainingExercise training during intensive medical treatment. Training mainly composed of endurance and resistance exercises. 3 to 5 times per week for six weeks. | Behavioural | Exercise group |
Primary outcome
Muscle strength: lower limb
Time frame: Six weeks (pre-post intervention)
Lower limb muscle strength measured by the load (kg) sustained in one repetition maximum test
7 secondary outcomes
Muscle strength: upper limb
Time frame: Six weeks (pre-post intervention)
Biomarker in Blood
Time frame: At the beginning of the intervention and three and six weeks after the beginning. Comparing the two time points inbetween study groups
Body composition
Time frame: Six weeks (pre-post intervention)
Six-minute-walk performance
Time frame: Six weeks (pre-post intervention)
Fatigue
Time frame: six weeks (pre-post intervention)
Quality of Life
Time frame: Six weeks (pre-post intervention)
Cardiorespiratory performance
Time frame: Six weeks (pre-post intervention)
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 4 Mar 2019.
- Derived from this study: PubMed 34860287Winker M, Stossel S, Neu MA, Lehmann N, El Malki K, Paret C, Joisten N, Bloch W, Zimmer P, Faber J. Exercise reduces systemic immune inflammation index (SII) in childhood cancer patients. Support Care Cancer. 2022 Apr;30(4):2905-2908. doi: 10.1007/s00520-021-06719-3. Epub 2021 Dec 3.
- Derived from this study: PubMed 32582585Stossel S, Neu MA, Wingerter A, Bloch W, Zimmer P, Paret C, Malki KE, Baumann FT, Russo A, Henninger N, Lehmann N, Otto H, Faber J. Benefits of Exercise Training for Children and Adolescents Undergoing Cancer Treatment: Results From the Randomized Controlled MUCKI Trial. Front Pediatr. 2020 Jun 5;8:243. doi: 10.3389/fped.2020.00243. eCollection 2020.
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Knowledge, Attitudes, Practice
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 Training in people with Pediatric Oncology, run by Johannes Gutenberg University Mainz 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 11 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 4 Mar 2019. 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?
Muscle strength: lower limb (time frame: Six weeks (pre-post intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02612025, which also lists 2 linked publications.
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 4 Mar 2019.