Pediatric OncologyFORTEeNCT05289739
Exercise Training in Childhood Cancer
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 multicenter study is to evaluate a personalised and standardised exercise intervention for children and adolescents undergoing anti-cancer treatment. Read more about this study
- Who is it for?
- Ages 4 to 21 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
- 478 participants
- Where
- 1 siteGermany
- Study dates
- 25 Apr 2022to 26 Jan 2026
- 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 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- First/initial diagnosis of a primary oncologic disease according to the International Classification of Childhood Cancer (ICCC), requiring chemotherapy and/or radiation therapy or First/initial diagnosis of a relapsed oncologic disease according to the International Classification of Childhood Cancer (ICCC), requiring chemotherapy and/or radiation therapy or First/initial diagnosis of a secondary oncologic disease according to the International Classification of Childhood Cancer (ICCC), requiring chemotherapy and/or radiation therapy
- Planned or started anti-cancer treatment (chemo- and/or radiotherapy) at one of the recruiting centres of the FORTEe trial
- The patient is assessed by the treating team (pediatric oncologist, exercise professional etc.) as suitable to participate in the trial, e.g. due to medical or psychological reasons.
- Existing informed consent (or assent) to participate in the study
- The patient (and the legal guardian) has/have sufficient knowledge of the respective national or English language so that it is possible to carry out the informed consent as well as interviews (in age-appropriate language).
- The patient is not in a terminal phase of the disease.
Who cannot join
- Oncologic disease (primary/relapsed/secondary) according to the International Classification of Childhood Cancer (ICCC), requiring neither chemotherapy nor radiation therapy or solely requiring surgery
- Reasons that already exist or are foreseeable at the time of study enrolment, due to which the patient will not have access to the exercise intervention and/or to the pre-test and/or to the post-test (e.g. foreseeable or planned, permanent change of treatment centre)
- The patient is assessed by the treating team (pediatric oncologist, exercise professional etc.) as unsuitable to participate in the trial, e.g. due to medical or psychological reasons.
- After detailed information and, if necessary, having time to consider, the patient (≥ 16 years of age) did not agree to give written informed consent to participate in the trial.
- The patient (and the legal guardians) has/have insufficient knowledge of the respective national or English language, so that it is not possible to carry out both the informed consent and interviews (in age-appropriate language).
- The patient is in a terminal phase of the disease
Trial locations and contacts
1 site in 1 country.
Germany1 site
Johannes-Gutenberg-University Medical Center
Mainz, Rhineland-Palatinate, 55131
About this study
Official title: Get Strong to Fight Childhood Cancer: An Exercise Intervention for Children and Adolescents Undergoing Anti-Cancer Treatment
The purpose of this multicenter study is to evaluate a personalised and standardised exercise intervention for children and adolescents undergoing anti-cancer treatment.
Read the detailed description
In the randomised, controlled FORTEe trial, high evidence for an innovative, patient-centred exercise treatment shall be generated. Supervised exercise training intents to increase muscle strength and reduce muscular atrophy due to bedrest. CRF and HRQoL can be improved and in the future, these benefits may help to fight childhood cancer by increasing therapy efficiency and survival rate. Within the project, digital, innovative technologies such as augmented reality will be developed and applied to make the exercise training more effective, age-adapted and personalised. Moreover, FORTEe will stimulate translational research to provide access to paediatric exercise oncology as a new health care intervention. As a progress beyond the current state-of-the-art, FORTEe has the ambition to implement paediatric exercise oncology as an evidence-based standard in clinical care for all childhood cancer patients across the EU and beyond.
- Conditions
- Pediatric Oncology
- Being tested
- Exercise training
- Keywords
- Paediatric exercise oncology, precision exercise training, childhood cancer, randomized controlled trial, quality of life, augmented reality, exercise technology
- Medical subject headings
- Neoplasms
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 cancer treatment. Training mainly consists of age-appropriate and personalized endurance, strength, flexibility, balance/coordination and gait training. Three to five weekly training sessions lasting 30 to 60 minutes each for about eight to ten weeks (depending on the course of the cancer treatment).
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Usual medical care + supervised exercise training during intensive medical treatment Receives: Behavioral: Exercise training |
| Control group | No intervention | Usual medical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the score of Cancer-related fatigue during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline
Cancer-related fatigue measured by the Pediatric Quality of Life Inventory (PedsQL) 3.0 Multidimensional Fatigue Scale. The PedsQL Multidimensional Fatigue Scale is composed of 18 items comprising three dimensions. Scores are transformed on a scale from 0 to 100. Higher scores indicate lower fatigue.
Measured: pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention
Secondary outcomes (42)
Change in the score of general Health-Related Quality of Life during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline
Health-Related Quality of Life measured by the Measurement Model for the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales questionnaire.
On the PedsQL Generic Core Scales, for ease of interpretability, items are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better HRQOL (Health-Related Quality of Life).
Measured: pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention
Change in the score of cancer-related Health-Related Quality of Life during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline
Health-Related Quality of Life measured by the Measurement Model for the Pediatric Quality of Life Inventory (PedsQL) 3.0 Cancer Module questionnaire.
Scores are transformed to a 0 to 100 scale. Higher scores indicate lower problems.
Measured: pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention
Change in the score of Mental Health (measured by WHO (Five) Well-Being Index) during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline
WHO (Five) Well-Being Index (1998 version) is used to measure Mental Health.The WHO-5 consists of five statements, which respondents rate according to the scale below:
All of the time = 5 Most of the time = 4 More than half of the time = 3 Less than half of the time = 2 Some of the time = 1 At no time = 0. The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.
Measured: pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention
Change in the score of Mental Health (measured by Warwick-Edinburgh Mental Well-being Scale (WEMWBS)) during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline
Warwick-Edinburgh Mental Well-being Scale (WEMWBS) is used to measure Mental Health. WEMWBS is a 14 item scale of mental well-being covering subjective well-being and psychological functioning, in which all items are worded positively and address aspects of positive mental health. The total score of the 14-item scale WEMWBS is obtained by summing the score for each of the 14 items. The scoring range for each item is from 1 - 5 and the total score is from 14-70.
Measured: pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention
Change in the score of Resilience (measured by Mainzer Resilience Scale for childhood cancer (MRScc)) during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline
Stress reactivity measured by the Mainz Resilience Score for childhood cancer (MRScc). The MRScc consists of 4 dimensions on mental health problems and 6 dimensions on stressor exposure. For both categories mental health problems and stressor exposure 4 - 400 points can be achieved. To calculate the resilience score, the category mental health problems is divided by the category stressor exposure. A score >0 means low resilience, a score < 0 means high resilience.
Measured: pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention
Change in the score of Resilience (measured by the Brief Resilience Scale (BRS)) during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline
Resilience will be evaluated using the Brief Resilience Scale (BRS). BRS is a 6 item scale, the items are rated from 1 to 5. A total score is calculated by determining the sum of the individual items which result in a total score ranging from 6 to 30. A higher score means a higher resilience.
Measured: pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention
Change in the score of Resilience (measured by the Child & Youth Resilience Measure-Revised (CYRM-R)) during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline
Resilience will be evaluated using the Child \& Youth Resilience Measure-Revised (CYRM-R).
The items within the measures can be directly summed to gain a total score of an individual's resilience. For the unmodified 5-point measure (with responses going from 1-5), the minimum score is 17 and the maximum score is 85. For the overall measure and subscales, higher scores indicate characteristics associated with resilience.
Measured: pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention
Change in the score of General self-efficacy during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline
General self-efficacy will be evaluated using the General self-efficacy scale (GSE). The total score is calculated by finding the sum of the 10 items. For the GSE, the total score ranges between 10 and 40, with a higher score indicating more self-efficacy.
Measured: pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention
Change in the score of Physical exercise self-efficacy during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline
Physical self-efficacy will be evaluated using the Physical exercise self-efficacy scale (PESE). The total score is calculated by finding the sum of the 10 items. For the GSE, the total score ranges between 5 and 20, with a higher score indicating more self-efficacy.
Measured: pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention
Change in the Physical activity level (measured by the Modifed Recent Physical Activity Questionnaire (mRPAQ)) during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline
Physical activity level will be evaluated using the Modifed Recent Physical Activity Questionnaire (mRPAQ).
The duration of listed physical activities were reported (recall time: over the past 7 days). Descriptive Statistics will be performed.
Measured: pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention
Change in the Physical activity level (measured by the Modified Youth Physical Activity Questionnaire (mYPAQ)) during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline
Physical activity level will be evaluated using Modified Youth Physical Activity Questionnaire (mYPAQ).
The duration of listed physical activities were reported (recall time: over the past 7 days). Descriptive Statistics will be performed.
Measured: pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention
Change in the Physical activity level (measured by the Modified Children's Physical Activity Questionnaire (mCPAQ)) during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline
Physical activity level will be evaluated using Modified Children's Physical Activity Questionnaire (mCPAQ).
The duration of listed physical activities were reported (recall time: over the past 7 days). Descriptive Statistics will be performed.
Measured: pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention
Change in the Physical activity level and behaviour during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline
In a semi-structured interview on physical activity, qualitative data will be collected regarding activity behaviour, motivating factors and barriers to physical activity.
Measured: pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention
Change in functional capacity after the intervention and after a 12-week follow-up compared to baseline
Measured via Six Minute Walk Test (6MWT). Functional capacity is evalauted by the walked distance.
Measured: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
Change in endurance performance (measured by the assisted 6-minute cycling test) after the intervention and after a 12-week follow-up compared to baseline
Measured via assisted 6-minute cycling test (A6MCT). Endurance performance is evaluated by the cumulative revolutions after 6 minutes.
Measured: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
Change in endurance performance (measured by the adapted Yo-Yo-Test) after the intervention and after a 12-week follow-up compared to baseline
Endurance performance will be evaluated by the adapted Yo-Yo-Test.
Measured: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
Longitudinal assessment of oxidative skeletal muscle impairment after the intervention and after a 12-week follow-up compared to baseline
Muscle impairment will be evaluated by near infrared spectroscopy (NIRS).
Measured: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
Change in peak oxygen uptake (VO2peak) after the intervention and after a 12-week follow-up compared to baseline
Cardiopulmonary Exercise Testing (CPET) will be performed during an endurance test to exhaustion to determine the peak oxygen uptake (VO2peak).
Measured: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
Change in motor function after the intervention and after a 12-week follow-up compared to baseline
measured via the quick motor function test
Measured: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
Change in hamstrings flexibility after the intervention and after a 12-week follow-up compared to baseline
measured via the sit and reach test
Measured: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
Change in lower limbs flexibility after the intervention and after a 12-week follow-up compared to baseline
a goniometer is used to measure the angles during foot, knee and hip flexion
Measured: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
Change in functional strength after the intervention and after a 12-week follow-up compared to baseline
Functional strength will be evaluated using the sit to stand test.
Measured: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
Change in arm strength after the intervention and after a 12-week follow-up compared to baseline
Arm strength will be evaluated using 5 repetition maximum for biceps curls.
Measured: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
Change in upper body strength after the intervention and after a 12-week follow-up compared to baseline
Upper body strength will be evaluated using medicine ball shot test.
Measured: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
Change in knee flexor strength after the intervention and after a 12-week follow-up compared to baseline
Knee flexor strength will be evaluated using a handheld dynamometer.
Measured: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
Change in leg extension strength after the intervention and after a 12-week follow-up compared to baseline
Leg extension strength will be evaluated using 5 repetition maximum for leg extension test measured via leg extension machine.
Measured: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
Change in functional mobility after the intervention and after a 12-week follow-up compared to baseline
Functional mobility will be evaluated using the timed up and down stairs test (TUDS).
Measured: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
Change in static balance after the intervention and after a 12-week follow-up compared to baseline
Static balance will be determined with the static stand test.
Measured: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
Change in body composition (measured via skinfold measurement) after the intervention and after a 12-week follow-up compared to baseline
Body composition is measured via plicometry of the triceps.
Measured: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
Change of the phase angle by means of bioelectrical impedance analysis for the examination of body composition after the intervention and after a 12-week follow-up compared to baseline
A multifrequency (5, 50, 100 kHz) bioelectrical impedance analysis is performed using a phase-sensitive impedance analyser (BIAcorpus RX4004M). For this purpose, a sinusoidal alternating current with a constant intensity is applied to the patient's wrists and ankles. The phase angle (PA, ° degree) is measured by the impedance analyser as the phase shift between current and voltage. The phase angle provides conclusions about nutritional status and body composition.
Measured: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
Change in body composition (measured via dual-energy x-ray absorptiometry) after the intervention and after a 12-week follow-up compared to baseline
In the dual energy X-ray absorptiometry (DEXA) total muscle mass and total fat mass is determined.
Measured: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
Usage frequency of the augmented reality (AR) app from baseline to the end of app use
Usage frequency derived from dates within an exercise diary is recorded during the entire time the AR (augmented reality) app is used.
Measured: during the use of the app from baseline until the end of app use (15 months after the end of intervention)
Usability of the augmented reality app
Exploration of app usability via user experience, incl. functions/features, technical bugs. For this purpose, qualitative data will be collected in a semi-structured interview.
Measured: post app use (15 months after the end of intervention)
Usability of the pixformance station
The pixformance station is a digital training tool. Pixformance usability should be explored through user experience, incl. functions/features, and technical bugs. For this purpose, qualitative data will be collected in a semi-structured interview.
Measured: post app use (15 months after the end of intervention)
Composite multidimensional socioeconomic status index
Socioeconomic status will be assessed in order to perform a confounder analysis for the main outcome cancer-related fatigue.
The calculation of the socioeconomic status index is based on the dimensions "levels of education", "occupational status" and "income". Scores for each dimension ranged from 1 to a maximum of 7. Since the 3 subscales are included in the calculation with the same weight, the socioeconomic status index can assume values between 3.0 and 21.0. Higher scores mean higher socioeconomic status.
Measured: pre-intervention
Change in the number of T-cells before start of anti-cancer treatment (baseline), pre-exercise intervention and post-exercise intervention
The purpose of the biomarker analysis is to describe peripheral circulating immune cell profiles and DNA methylation status at baseline (T-1) (i.e. before chemo- and/or radiotherapy), and pre- (T0) and post-exercise intervention (T1) (both during chemo- and/or radiotherapy) solely in adolescent and young adult patients suffering from a solid tumour excluding cancers of the immune system e.g. leukemia and lymphoma.
Measured: Blood sampling before start of anti-cancer treatment (chemo- and/or radiotherapy); pre-intervention; end of intervention (assessed up to 10 weeks)
Change in the number of B-cells before start of anti-cancer treatment (baseline), pre-exercise intervention and post-exercise intervention
The purpose of the biomarker analysis is to describe peripheral circulating immune cell profiles and DNA methylation status at baseline (T-1) (i.e. before chemo- and/or radiotherapy), and pre- (T0) and post-exercise intervention (T1) (both during chemo- and/or radiotherapy) solely in adolescent and young adult patients suffering from a solid tumour excluding cancers of the immune system e.g. leukemia and lymphoma.
Measured: Blood sampling before start of anti-cancer treatment (chemo- and/or radiotherapy); pre-intervention; end of intervention (assessed up to 10 weeks)
Change in the number of NK-cells before start of anti-cancer treatment (baseline), pre-exercise intervention and post-exercise intervention
The purpose of the biomarker analysis is to describe peripheral circulating immune cell profiles and DNA methylation status at baseline (T-1) (i.e. before chemo- and/or radiotherapy), and pre- (T0) and post-exercise intervention (T1) (both during chemo- and/or radiotherapy) solely in adolescent and young adult patients suffering from a solid tumour excluding cancers of the immune system e.g. leukemia and lymphoma.
Measured: Blood sampling before start of anti-cancer treatment (chemo- and/or radiotherapy); pre-intervention; end of intervention (assessed up to 10 weeks)
Change in the number of leukocytes before start of anti-cancer treatment (baseline), pre-exercise intervention and post-exercise intervention
The purpose of the biomarker analysis is to describe peripheral circulating immune cell profiles and DNA methylation status at baseline (T-1) (i.e. before chemo- and/or radiotherapy), and pre- (T0) and post-exercise intervention (T1) (both during chemo- and/or radiotherapy) solely in adolescent and young adult patients suffering from a solid tumour excluding cancers of the immune system e.g. leukemia and lymphoma.
Measured: Blood sampling before start of anti-cancer treatment (chemo- and/or radiotherapy); pre-intervention; end of intervention (assessed up to 10 weeks)
Change in the number of monocytes before start of anti-cancer treatment (baseline), pre-exercise intervention and post-exercise intervention
The purpose of the biomarker analysis is to describe peripheral circulating immune cell profiles and DNA methylation status at baseline (T-1) (i.e. before chemo- and/or radiotherapy), and pre- (T0) and post-exercise intervention (T1) (both during chemo- and/or radiotherapy) solely in adolescent and young adult patients suffering from a solid tumour excluding cancers of the immune system e.g. leukemia and lymphoma.
Measured: Blood sampling before start of anti-cancer treatment (chemo- and/or radiotherapy); pre-intervention; end of intervention (assessed up to 10 weeks)
Change in the DNA methylation status of T cells before start of anti-cancer treatment (baseline), pre-exercise intervention and post-exercise intervention
The purpose of the biomarker analysis is to describe peripheral circulating immune cell profiles and DNA methylation status at baseline (T-1) (i.e. before chemo- and/or radiotherapy), and pre- (T0) and post-exercise intervention (T1) (both during chemo- and/or radiotherapy) solely in adolescent and young adult patients suffering from a solid tumour excluding cancers of the immune system e.g. leukemia and lymphoma.
Measured: Blood sampling before start of anti-cancer treatment (chemo- and/or radiotherapy); pre-intervention; end of intervention (assessed up to 10 weeks)
Change in the DNA methylation status of NK cells before start of anti-cancer treatment (baseline), pre-exercise intervention and post-exercise intervention (baseline), pre-exercise intervention and post-exercise intervention
The purpose of the biomarker analysis is to describe peripheral circulating immune cell profiles and DNA methylation status at baseline (T-1) (i.e. before chemo- and/or radiotherapy), and pre- (T0) and post-exercise intervention (T1) (both during chemo- and/or radiotherapy) solely in adolescent and young adult patients suffering from a solid tumour excluding cancers of the immune system e.g. leukemia and lymphoma.
Measured: Blood sampling before start of anti-cancer treatment (chemo- and/or radiotherapy); pre-intervention; end of intervention (assessed up to 10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start25 Apr 2022
- Primary completion26 Jan 2026
- Study completion26 Jan 2026
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
- 478 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Heidelberg, Centre Leon Berard, Oxford Brookes University, Fondazione Monza e Brianza per il Bambino e la sua Mamma (MBBM), European University of Madrid, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, University Medical Centre Ljubljana, Copenhagen University Hospital, Rigshospitalet, German Sport University, Cologne, University Hospital, Essen
- Responsible party
- Principal investigator, Joerg Faber, Johannes Gutenberg University Mainz
- Investigators
- Jörg Faber, Univ.-Prof. Dr. med., Principal investigator, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05289739
- Sponsor's protocol ID
- UMC-Mainz: 21-00338
- Acronym
- FORTEe
- Status last verified
- Feb 2026
- First submitted
- 18 Jan 2022
- Last updated
- 9 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Solera-Sanchez A, Marriott H, Windsor S, Straun K, Neu MA, Dreismickenbecker E, Lanfranconi F, Peli L, Wiskemann J, Bauer N, Spreafico F, Zardo W, Baader T, Wright P, Faber J, Watson E; FORTEe Consortium. The use of motion tracking technology to support an exercise intervention for children and young people with cancer: perspectives of users and healthcare professionals in the FORTEe trial. Front Pediatr. 2026 Jul 8;14:1879166. doi: 10.3389/fped.2026.1879166. eCollection 2026.
PubMed 42488233Neu MA, Dreismickenbecker E, Lanfranconi F, Stossel S, Balduzzi A, Wright P, Windsor S, Wiskemann J, El-Rajab I, Lucia A, Fiuza-Luces C, Mongondry R, Fridh MK, Spreafico F, Konda B, Kitanovski L, Heisserer B, Polak M, Baader T, Bloch W, Gotte M; Network ActiveOncoKids; Rizvi K; Youth Cancer Europe; Ruckes C, Paul NW, Faber J; FORTEe Consortium. Get strong to fight childhood cancer - an exercise intervention for children and adolescents undergoing anti-cancer treatment (FORTEe): Rationale and design of a randomized controlled exercise trial. BMC Cancer. 2025 Aug 7;25(1):1275. doi: 10.1186/s12885-025-14489-y.
PubMed 40775303
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Get Strong to Fight Childhood Cancer: An Exercise Intervention for Children and Adolescents Undergoing Anti-Cancer Treatment
- ClinicalTrials.gov ID
- NCT05289739
- Acronym / sponsor ID
- FORTEe / UMC-Mainz: 21-00338
- Conditions
- Pediatric Oncology
- Keywords
- Paediatric exercise oncology, precision exercise training, childhood cancer, randomized controlled trial, quality of life, augmented reality, exercise technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 478 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Collaborators
- University Hospital Heidelberg, Centre Leon Berard, Oxford Brookes University, Fondazione Monza e Brianza per il Bambino e la sua Mamma (MBBM), European University of Madrid, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, University Medical Centre Ljubljana, Copenhagen University Hospital, Rigshospitalet, German Sport University, Cologne, University Hospital, Essen
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- 26 Jan 2026 (actual)
- Study completion
- 26 Jan 2026 (actual)
- First posted
- 21 Mar 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.
The purpose of this multicenter study is to evaluate a personalised and standardised exercise intervention for children and adolescents undergoing anti-cancer treatment.
Detailed description
In the randomised, controlled FORTEe trial, high evidence for an innovative, patient-centred exercise treatment shall be generated. Supervised exercise training intents to increase muscle strength and reduce muscular atrophy due to bedrest. CRF and HRQoL can be improved and in the future, these benefits may help to fight childhood cancer by increasing therapy efficiency and survival rate. Within the project, digital, innovative technologies such as augmented reality will be developed and applied to make the exercise training more effective, age-adapted and personalised. Moreover, FORTEe will stimulate translational research to provide access to paediatric exercise oncology as a new health care intervention. As a progress beyond the current state-of-the-art, FORTEe has the ambition to implement paediatric exercise oncology as an evidence-based standard in clinical care for all childhood cancer patients across the EU and beyond.
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 trainingUsual medical care + supervised exercise training during intensive medical treatment |
| Control group | No intervention | –Usual medical care |
Who may qualify
- Ages
- 4 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- First/initial diagnosis of a primary oncologic disease according to the International Classification of Childhood Cancer (ICCC), requiring chemotherapy and/or radiation therapy or First/initial diagnosis of a relapsed oncologic disease according to the International Classification of Childhood Cancer (ICCC), requiring chemotherapy and/or radiation therapy or First/initial diagnosis of a secondary oncologic disease according to the International Classification of Childhood Cancer (ICCC), requiring chemotherapy and/or radiation therapy
- Planned or started anti-cancer treatment (chemo- and/or radiotherapy) at one of the recruiting centres of the FORTEe trial
- The patient is assessed by the treating team (pediatric oncologist, exercise professional etc.) as suitable to participate in the trial, e.g. due to medical or psychological reasons.
- Existing informed consent (or assent) to participate in the study
- The patient (and the legal guardian) has/have sufficient knowledge of the respective national or English language so that it is possible to carry out the informed consent as well as interviews (in age-appropriate language).
Key exclusion criteria (6 listed)
- Oncologic disease (primary/relapsed/secondary) according to the International Classification of Childhood Cancer (ICCC), requiring neither chemotherapy nor radiation therapy or solely requiring surgery
- Reasons that already exist or are foreseeable at the time of study enrolment, due to which the patient will not have access to the exercise intervention and/or to the pre-test and/or to the post-test (e.g. foreseeable or planned, permanent change of treatment centre)
- The patient is assessed by the treating team (pediatric oncologist, exercise professional etc.) as unsuitable to participate in the trial, e.g. due to medical or psychological reasons.
- After detailed information and, if necessary, having time to consider, the patient (≥ 16 years of age) did not agree to give written informed consent to participate in the trial.
- The patient (and the legal guardians) has/have insufficient knowledge of the respective national or English language, so that it is not possible to carry out both the informed consent and interviews (in age-appropriate language).
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 cancer treatment. Training mainly consists of age-appropriate and personalized endurance, strength, flexibility, balance/coordination and gait training. Three to five weekly training sessions lasting 30 to 60 minutes each for about eight to ten weeks (depending on the course of the cancer treatment). | Behavioural | Exercise group |
Primary outcome
Change in the score of Cancer-related fatigue during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline
Time frame: pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention
Cancer-related fatigue measured by the Pediatric Quality of Life Inventory (PedsQL) 3.0 Multidimensional Fatigue Scale. The PedsQL Multidimensional Fatigue Scale is composed of 18 items comprising three dimensions. Scores are transformed on a scale from 0 to 100. Higher scores indicate lower fatigue.
42 secondary outcomes
Change in the score of general Health-Related Quality of Life during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline
Time frame: pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention
Change in the score of cancer-related Health-Related Quality of Life during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline
Time frame: pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention
Change in the score of Mental Health (measured by WHO (Five) Well-Being Index) during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline
Time frame: pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention
Change in the score of Mental Health (measured by Warwick-Edinburgh Mental Well-being Scale (WEMWBS)) during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline
Time frame: pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention
Change in the score of Resilience (measured by Mainzer Resilience Scale for childhood cancer (MRScc)) during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline
Time frame: pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention
Change in the score of Resilience (measured by the Brief Resilience Scale (BRS)) during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline
Time frame: pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention
Change in the score of Resilience (measured by the Child & Youth Resilience Measure-Revised (CYRM-R)) during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline
Time frame: pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention
Change in the score of General self-efficacy during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline
Time frame: pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention
Change in the score of Physical exercise self-efficacy during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline
Time frame: pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention
Change in the Physical activity level (measured by the Modifed Recent Physical Activity Questionnaire (mRPAQ)) during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline
Time frame: pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention
Change in the Physical activity level (measured by the Modified Youth Physical Activity Questionnaire (mYPAQ)) during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline
Time frame: pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention
Change in the Physical activity level (measured by the Modified Children's Physical Activity Questionnaire (mCPAQ)) during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline
Time frame: pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention
Change in the Physical activity level and behaviour during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline
Time frame: pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention
Change in functional capacity after the intervention and after a 12-week follow-up compared to baseline
Time frame: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
Change in endurance performance (measured by the assisted 6-minute cycling test) after the intervention and after a 12-week follow-up compared to baseline
Time frame: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
Change in endurance performance (measured by the adapted Yo-Yo-Test) after the intervention and after a 12-week follow-up compared to baseline
Time frame: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
Longitudinal assessment of oxidative skeletal muscle impairment after the intervention and after a 12-week follow-up compared to baseline
Time frame: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
Change in peak oxygen uptake (VO2peak) after the intervention and after a 12-week follow-up compared to baseline
Time frame: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
Change in motor function after the intervention and after a 12-week follow-up compared to baseline
Time frame: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
Change in hamstrings flexibility after the intervention and after a 12-week follow-up compared to baseline
Time frame: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
Change in lower limbs flexibility after the intervention and after a 12-week follow-up compared to baseline
Time frame: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
Change in functional strength after the intervention and after a 12-week follow-up compared to baseline
Time frame: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
Change in arm strength after the intervention and after a 12-week follow-up compared to baseline
Time frame: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
Change in upper body strength after the intervention and after a 12-week follow-up compared to baseline
Time frame: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
Change in knee flexor strength after the intervention and after a 12-week follow-up compared to baseline
Time frame: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
Change in leg extension strength after the intervention and after a 12-week follow-up compared to baseline
Time frame: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
Change in functional mobility after the intervention and after a 12-week follow-up compared to baseline
Time frame: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
Change in static balance after the intervention and after a 12-week follow-up compared to baseline
Time frame: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
Change in body composition (measured via skinfold measurement) after the intervention and after a 12-week follow-up compared to baseline
Time frame: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
Change of the phase angle by means of bioelectrical impedance analysis for the examination of body composition after the intervention and after a 12-week follow-up compared to baseline
Time frame: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
Change in body composition (measured via dual-energy x-ray absorptiometry) after the intervention and after a 12-week follow-up compared to baseline
Time frame: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
Usage frequency of the augmented reality (AR) app from baseline to the end of app use
Time frame: during the use of the app from baseline until the end of app use (15 months after the end of intervention)
Usability of the augmented reality app
Time frame: post app use (15 months after the end of intervention)
Usability of the pixformance station
Time frame: post app use (15 months after the end of intervention)
Composite multidimensional socioeconomic status index
Time frame: pre-intervention
Change in the number of T-cells before start of anti-cancer treatment (baseline), pre-exercise intervention and post-exercise intervention
Time frame: Blood sampling before start of anti-cancer treatment (chemo- and/or radiotherapy); pre-intervention; end of intervention (assessed up to 10 weeks)
Change in the number of B-cells before start of anti-cancer treatment (baseline), pre-exercise intervention and post-exercise intervention
Time frame: Blood sampling before start of anti-cancer treatment (chemo- and/or radiotherapy); pre-intervention; end of intervention (assessed up to 10 weeks)
Change in the number of NK-cells before start of anti-cancer treatment (baseline), pre-exercise intervention and post-exercise intervention
Time frame: Blood sampling before start of anti-cancer treatment (chemo- and/or radiotherapy); pre-intervention; end of intervention (assessed up to 10 weeks)
Change in the number of leukocytes before start of anti-cancer treatment (baseline), pre-exercise intervention and post-exercise intervention
Time frame: Blood sampling before start of anti-cancer treatment (chemo- and/or radiotherapy); pre-intervention; end of intervention (assessed up to 10 weeks)
Change in the number of monocytes before start of anti-cancer treatment (baseline), pre-exercise intervention and post-exercise intervention
Time frame: Blood sampling before start of anti-cancer treatment (chemo- and/or radiotherapy); pre-intervention; end of intervention (assessed up to 10 weeks)
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 9 Feb 2026.
- Derived from this study: PubMed 42488233Solera-Sanchez A, Marriott H, Windsor S, Straun K, Neu MA, Dreismickenbecker E, Lanfranconi F, Peli L, Wiskemann J, Bauer N, Spreafico F, Zardo W, Baader T, Wright P, Faber J, Watson E; FORTEe Consortium. The use of motion tracking technology to support an exercise intervention for children and young people with cancer: perspectives of users and healthcare professionals in the FORTEe trial. Front Pediatr. 2026 Jul 8;14:1879166. doi: 10.3389/fped.2026.1879166. eCollection 2026.
- Derived from this study: PubMed 40775303Neu MA, Dreismickenbecker E, Lanfranconi F, Stossel S, Balduzzi A, Wright P, Windsor S, Wiskemann J, El-Rajab I, Lucia A, Fiuza-Luces C, Mongondry R, Fridh MK, Spreafico F, Konda B, Kitanovski L, Heisserer B, Polak M, Baader T, Bloch W, Gotte M; Network ActiveOncoKids; Rizvi K; Youth Cancer Europe; Ruckes C, Paul NW, Faber J; FORTEe Consortium. Get strong to fight childhood cancer - an exercise intervention for children and adolescents undergoing anti-cancer treatment (FORTEe): Rationale and design of a randomized controlled exercise trial. BMC Cancer. 2025 Aug 7;25(1):1275. doi: 10.1186/s12885-025-14489-y.
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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.
Jörg Faber, Univ.-Prof. Dr. med. principal investigator
Johannes Gutenberg University Mainz
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 6 inclusion and 6 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 9 Feb 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?
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 in the score of Cancer-related fatigue during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline (time frame: pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of 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 NCT05289739, 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 9 Feb 2026.