Pediatric Cancer PatientsBEPPONCT07647471
Evaluation of an Exercise Intervention During Intensive Medical Treatment in Pediatric Oncology.
A study testing Partially-standardised, supervised, continuity-of-care exercise intervention in people with Pediatric Cancer Patients, run by Universität Duisburg-Essen at 13 sites in Germany.
Trial summary
The BEPPO study is a Germany-wide clinical trial investigating whether a structured exercise program can improve physical and mental health in children and adolescents undergoing cancer treatment. Although exercise is known to support recovery and well-being, it is not yet a standard part of pediatric oncology care. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Pediatric Cancer Patients
- What is being tested?
- Partially-standardised, supervised, continuity-of-care exercise intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 346 participants
- Where
- 13 sitesGermany
- Study dates
- 1 Jul 2026to 31 Dec 2028
- Phase
- Interventional
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients aged ≥3 and ≤18 years
- Oncological diagnosis with curative treatment intent
- ≤6 weeks since cancer diagnosis (diagnosis can be initial, secondary or relapse diagnosis)
- Information and consent procedures feasible in German, English or with using local site resources (e.g., interpreters or multilingual staff)
- Communication with the patient is possible in German, English or with using local site resources (e.g., interpreters or multilingual staff) during the assessments and intervention
- Patients insured by German statutory health insurers
Who cannot join
- Patients aged <3 and >18 years
- No active medical oncological treatment (e.g., watch-and-wait strategy, surgery without ongoing oncological acute treatment at a pediatric oncology center)
- Medical limitations that do not allow implementation of the study protocol
- Life expectancy < 6 months
- Patients not insured by German statutory health insurers (e.g., Privatly insured patients, self-paying patients)
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
Germany13 sites, 13 recruiting
- Recruiting
Charité-Universitätsmedizin Berlin, Department of Pediatric Oncology/Hematology
Berlin
Pablo Hernaiz Driever, 0049 30 450666173, pablo.hernaiz@charite.de
- Recruiting
University of Bonn Medical Center, Department of Pediatric Hematology/Oncology,
Bonn
Gabriele Calaminus, 0228 287 33389, gabriele.calaminus@ukbonn.de
- Recruiting
Children's Hospital Amsterdamer Straße, ; Clinic for Children and Youth Medicine; Department for pediatric hematology/oncology
Cologne
Meinolf Siepermann, 0049 221 8907 5158, siepermannm@kliniken-koeln.de
- Recruiting
University Hospital Cologne, Department of Pediatric Oncology and Hematology, Children's Hospital
Cologne
Thorsten Simon, 0049 221 478 40687, thorsten.simon@uk-koeln.de
- Recruiting
University Hospital Essen, Department of Pediatric Hematology/Oncology, Center for Child and Adolescent Medicine, Clinic for Pediatrics III
Essen
Uta Dirksen, 0049 201 723 8084, uta.dirksen@uk-essen.de
- Recruiting
Universitätsmedizin Frankfurt, Department of Pediatrics, Pediatric Oncology and Haematology
Frankfurt
Mirjam Dieckelmann, 069 6301 85879, dieckelmann@allgemeinmedizin.uni-frankfurt.de
- Recruiting
Universitätsklinikum Hamburg-Eppendorf, Department of Pediatric Hematology and Oncology, Hubertus Wald Tumor Center, University Cancer Center Hamburg
Hamburg
Gabriele Escherich, 0049 40 7410 53796, escherich@uke.de
Simon Elmers, 0049 40 7410 52624, s.elmers@uke.de
- Recruiting
Universitätsklinikum Jena, Klinik für Kinder- und Jugendmedizin
Jena
Jana Ernst, 0049 07747, jana.ernst@med.uni-jena.de
- Recruiting
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Department of Pediatric Hematology/Oncology
Mainz
Jörg Faber, 0049 6131 17 8331, faber@uni-mainz.de
- Recruiting
Pädiatrische Hämatologie und Onkologie, Zelltherapie Zentrum für Kinder- und Jugendmedizin Eine Kooperation der München Klinik und des TUM Klinikums
München
Sabine Kesting, 0049 89 3068 7411, sabine.kesting@tum.de
- Recruiting
DIAKONEO Klinik Hallerwiese-Cnopfsche Kinderklinik Nürnberg, Department of Pediatric Hematology and Oncology
Nuremberg
Jörg Leyh, 0911 3340 4816, Joerg.Leyh@diakoneo.de
- Recruiting
Klinikum der Landeshauptstadt Stuttgart, Zentrum für Kinder-, Jugend- und Frauenmedizin, Pädiatrie
Stuttgart
Claudia Blattmann, 0049 711 2787 2460, c.blattmann@klinikum-stuttgart.de
Dominik Gaser, d.gaser@klinikum-stuttgart.de
- Recruiting
University Medical Center Ulm, Department of Pediatrics and Adolescent Medicine
Ulm
Miriam Erlacher, 073150057001, miriam.erlacher@uniklinik-ulm.de
Lisa Nonnenmacher, Lisa.Nonnenmacher@uniklinik-ulm.de
About this study
Official title: Evaluation of an Exercise Intervention During Intensive Medical Treatment in Pediatric Oncology (Evaluation BEwegungs- Und sPorttherapeutischer Interventionen Unter Medizinischer Therapie in Der Pädiatrischen Onkologie)
The BEPPO study is a Germany-wide clinical trial investigating whether a structured exercise program can improve physical and mental health in children and adolescents undergoing cancer treatment. Although exercise is known to support recovery and well-being, it is not yet a standard part of pediatric oncology care. The study aims to generate evidence to support the integration of exercise into routine treatment.
A total of 346 patients aged 3 to 18 years are recruited across 13 pediatric oncology centers in Germany. Participants are randomly assigned to either an exercise intervention group or a standard care control group.
Read more
Children in the intervention group take part in a 6-month individualized exercise program with 3-5 sessions per week. The program is delivered across different settings, including inpatient hospital care, outpatient treatment, and home-based training supported by telemedicine. This ensures continuous support throughout the course of medical treatment.
In addition to supervised exercise sessions, participants receive four structured counseling sessions. These sessions aim to strengthen motivation, address individual barriers to participation, and support long-term engagement in physical activity. The counseling also helps build a strong therapeutic relationship and promotes adherence to the program.
The exercise intervention is based on established principles of sports science but is individually adapted to each patient's health status, treatment phase, and personal preferences. Each training session follows a structured plan with specific goals, while also considering individual physical and psychological conditions to ensure safety, feasibility, and effectiveness.
The main objective of the BEPPO study is to improve physical performance, particularly leg strength, which is the primary endpoint. Secondary outcomes include endurance, functional mobility, balance, physical activity levels, fatigue, quality of life, mental well-being, frailty, and treatment-related symptoms and side effects.
In addition to clinical effectiveness, the study also evaluates how well the intervention can be implemented in routine healthcare settings. This includes assessing adherence, feasibility, and potential barriers and facilitators for integrating exercise into standard care. A health economic evaluation is also conducted in collaboration with health insurance providers to determine cost implications.
Overall, the BEPPO study aims to provide robust scientific evidence on the benefits and feasibility of structured exercise during pediatric cancer treatment. The long-term goal is to establish exercise as a standard component of supportive care in pediatric oncology, improving both short- and long-term outcomes for patients.
- Conditions
- Pediatric Cancer Patients
- Being tested
- Partially-standardised, supervised, continuity-of-care exercise intervention
- Keywords
- Knee extensor strength, Quality of Life, Fatigue, Health economics, Implementation, Physical activity, Exercise
- Medical subject headings
- Fatigue, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partially-standardised, supervised, continuity-of-care exercise interventionBehavioural
Exercise sessions:
3-5x/week over 6 months (minimum of 78 sessions in total), duration: 30 minutes, partially-standardised with a primarily focus on strength and endurance exercises, additional components: coordination, flexibility, and balance exercises, supervised by exercise professionals, continuity-of-care achieved through hospital-based (in-patient/out-patient), and home-based online sessions
Exercise counselling:
4x sessions in 12 months, family-centred exercise counselling, primary focus on understanding barriers and facilitators to physical activity and increasing intrinsic motivation for participating in the exercise session
| Study group | Role | What they receive |
|---|---|---|
| BEPPO-group | Experimental | Patients in the BEPPO group participate in 3-5 partially standardized, supervised exercise sessions per week (30 minutes each), aiming for at least 78 sessions during the 6-month intervention period. Sessions are delivered in hospital settings (inpatient ward, outpatient clinic, or day clinic) and online during periods at home.
Exercises are individually adapted to age, health status, treatment phase, and interests.Primary focus are endurance and strength exercises, additionally coordination, flexibility, and balance exercises. Treatment-related side effects are continuously considered. Online sessions are delivered via video platforms; alternatively, individualized home exercise plans are provided.
Additionally, patients and families participate in four family-centered exercise counselling sessions to identify barriers and facilitators to physical activity, define individualized goals, and support long-term adherence through increaseing patients intrinsic motivation. Receives: Behavioral: Partially-standardised, supervised, continuity-of-care exercise intervention |
| Control group | No intervention | Patients in the control group do not receive a standardized exercise intervention but may participate in the existing site-specific exercise-related usual care services offered at their respective study sites. The availability and extent of these services vary considerably across the 13 participating study sites, ranging from no exercise support to comprehensive hospital-based exercise programs during intensive cancer treatment, depending on local staffing and structural resources. Existing exercise programs are delivered exclusively within the hospital setting (inpatient ward, outpatient clinic, or day clinic) and are based on local practice rather than a standardized intervention protocol. Neither online exercise support during periods at home nor structured exercise counselling sessions are part of usual care at any participating study site. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal leg extensor strength
Measured using a CITEC handheld dynamometer on the dominant side unless medically contraindicated. Patients are positioned prone with the knee flexed to 90°; if lying prone is not possible for medical reasons, the assessment is performed in a seated position. The dynamometer is placed anteriorly at the distal lower leg (shin). Outcome measure: maximal muscle strength (Newton; range 0.0-500.0). Interpretation: Higher values indicate greater muscle strength.
Measured: At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Secondary outcomes (22)
Maximal handgrip strength
Measured using a CITEC handheld dynamometer with a fist-grip applicator on the dominant side (unless medically contraindicated; in this case, the non-dominant side is assessed at all time points). Patients are seated with the elbow flexed to 90°. The dynamometer is placed in the patient's fist. Outcome measure: maximal muscle strength (Newton; range 0.0-500.0). Interpretation: Higher values indicate greater muscle strength.
Measured: At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Maximal dorsiflexor strength
Measured: At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement
Maximal arm flexion strength
Measured using a CITEC handheld dynamometer on the dominant side (unless medically contraindicated; in this case, the non-dominant side is assessed at all time points). Patients are lying down on their back with the elbow flexed at 90°. The dynamometer is placed at the patient's wrist. Outcome measure: maximal muscle strength (Newton; range 0.0-500.0). Interpretation: Higher values indicate greater muscle strength.
Measured: At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Sit and Reach Test (Mobility of the torso and lower back)
Measured using a Sit-and-Reach Box (Baseline). Patients are seated on the floor with their legs straight and their feet positioned against the box. The patient leans forward with both hands while keeping the legs straight, reaching as far forward as possible without changing the leg position, and moves the sliding device forward with the fingertips. The end position must be held for 2 seconds. No bouncing or jerking movements are allowed; only pain-free movements are permitted. Measurement is taken at the endpoint.
Outcome measure: Forward lean in cm (Range: 6-59 cm). Interpretation: Higher values indicate greater flexibility.
Measured: At baseline (T0), and at 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Tandem Stand (10s, eyes-open)
Measured using the Tandem Stand test. Patients are instructed to stand with one foot directly in front of the other, with the heel of the front foot touching the toes of the back foot. Arms are positioned comfortably at the sides of the body. Patients are asked to maintain this position for 10 seconds without moving the feet or requiring external support.
Outcome measure: Time (seconds) maintained in tandem stance (Range: 0-10 seconds).
Interpretation: Higher values indicate better balance.
Measured: At baseline (T0), and at 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Tandem Stand (10s, eyes-closed)
Measured using the Tandem Stand test with eyes closed. Patients are instructed to stand with one foot directly in front of the other, with the heel of the front foot touching the toes of the back foot. Once a stable position is achieved, patients close their eyes and are asked to maintain the position for 10 seconds without moving the feet, opening the eyes, or requiring external support.
Outcome measure: Time (seconds) maintained in tandem stance with eyes closed (Range: 0-10 seconds).
Interpretation: Higher values indicate better balance.
Measured: At baseline (T0), and at 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Single-leg Stance (10s)
Measured using the Single-Leg Stance test. Patients are instructed to stand on one leg with their eyes open while keeping the other foot off the ground. Arms are positioned comfortably at the sides of the body. Patients are asked to maintain the position for up to 10 seconds without touching the raised foot to the ground, moving the stance foot, or requiring external support. Time is recorded at the endpoint, with a maximum score of 10 seconds.
Outcome measure: Time (seconds) maintained in single-leg stance (Range: 0-10 seconds).
Interpretation: Higher values indicate better balance.
Measured: At baseline (T0), and at 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Sit to Stand (5x STS)
Measured using the Five Times Sit-to-Stand Test (5xSTS). The starting position is seated on a chair with the knees flexed to 90°. Arms are crossed in front of the body, with the hands touching the opposite shoulders, to restrict arm movements. Patients are instructed to stand up fully and sit down again as quickly as possible for a total of five repetitions. Timing starts on the command "Go" and stops when the patient reaches the standing position at the end of the fifth repetition.
Outcome measure: Time to complete five sit-to-stand repetitions (seconds).
Interpretation: Lower values indicate better functional lower-extremity strength and mobility.
Measured: At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Timed up and go (TUG 3m)
Measured using the Timed Up and Go (TUG) Test. The starting position is seated on a chair with the knees flexed to 90°. Arms are crossed in front of the body, with the hands touching the opposite shoulders, to restrict arm movements. Patients are instructed to stand up from the chair, walk 3 meters at a comfortable and safe pace, turn around, walk back to the chair, and sit down again. Timing starts on the command "Go" and stops when the patient is seated again.
Outcome measure: Time to complete the Timed Up and Go test (seconds).
Interpretation: Lower values indicate better functional mobility and dynamic balance.
Measured: At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
2-Minute Walking Test (2MWT)
Measured using the 2-Minute Walk Test (2MWT). Patients are instructed to walk back and forth along a 15-meter walkway for a duration of 2 minutes. They are encouraged to walk as far as possible at a self-selected, comfortable and safe pace. Rest breaks are permitted if needed, but the timer continues to run. The total distance covered within the 2-minute period is recorded.
Outcome measure: Distance walked in 2 minutes (meters).
Interpretation: Higher values indicate better functional walking capacity and endurance.
Measured: At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Body Mass Index (in Percentiles)
BMI is calculated from body weight and height and expressed in percentiles. Body weight (kg) and body height (m) are measured using standard procedures. Body Mass Index (BMI) is calculated as weight divided by height squared (kg/m²). BMI values are then converted into age- and sex-specific percentiles.
Outcome measure: BMI percentile.
Interpretation: Higher percentiles indicate higher relative body mass compared to age- and sex-matched reference populations.
Measured: At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Waist-to-hip ratio (WHR)
Waist-to-hip ratio (WHR) is calculated from waist and hip circumferences. Waist circumference is measured at the narrowest point between the lower costal margin and the iliac crest, and hip circumference is measured at the widest point over the buttocks, using a standardized measuring tape. Both measurements are taken in a standing position. Waist-to-hip ratio is calculated by dividing waist circumference by hip circumference.
Outcome measure: Waist-to-hip ratio (unitless).
Interpretation: Higher values indicate a greater proportion of abdominal fat distribution.
Measured: At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Estimate body fat and lean mass
Estimations are based on triceps skinfold thickness which is measured using a skinfold caliper (Harpender). The measurement is taken at the midpoint between the acromion and the olecranon process on the posterior side of the upper arm. The skinfold is grasped firmly between thumb and index finger, and the caliper is applied perpendicular to the fold approximately 1 cm below the fingers. The measurement is taken after the caliper reading stabilizes. Measured only on healthy skin.
Outcome measure: Triceps skinfold thickness (mm).
Interpretation: Higher values indicate greater subcutaneous fat mass.
Measured: At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Objective physical activity
Measured using a Movisens monitor (Move4) over a 7-day period. Participants are instructed to wear the Movisens monitor continuously for 7 consecutive days during waking hours, removing it only for water-based activities if required. The device records habitual physical activity under free-living conditions. Data are collected over the full monitoring period and processed according to standardized algorithms.
Outcome measure: Objective physical activity over 7 days (amongst others minutes of moderate-to-vigorous physical activity).
Interpretation: Higher values indicate higher levels spend in moderate-to-vigorous physical activity.
Measured: At baseline (T0), and at 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Subjective physical activity levels
Subjective physical activity level is assessed using the ActiOn! questionnaire. The ActiOn! questionnaire is based on the KiGGS questionnaire and has been adapted to reflect the daily reality of children with cancer undergoing intensive therapy. It is used to capture subjective physical activity before, during and after treatment.
Outcome measure: Subjective physical activity level (questionnaire-based score) measured by minutes of (moderate to vigorous) activity per week/per day in different setting, MET-hours.
Interpretation: Higher score indicate high activity levels.
Measured: At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Health-related quality of life
Assessed using the Pediatric Quality of Life Inventory (PedsQL), specifically the PedsQL 4.0 Generic Core Scales Short Form (SF15), supplemented with the Cancer module. The instrument is designed for children and adolescents and captures the dimensions of physical, emotional, social, and school (or cognitive) functioning. This questionnaire is assessed in participants and their caregivers. The combined questionnaires consist of a total of 42 closed-ended items.
Outcome measure: Health-related quality of life (PedsQL score).
Interpretation: Higher scores indicate better Health-related quality of life.
Measured: At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Fatigue
Assessed using the Pediatric Quality of Life Inventory (PedsQL) Multidimensional Fatigue Scale (PedsQL 3.0). The questionnaire consists of 18 closed-ended items and is used to evaluate fatigue symptoms in children and adolescents. This questionnaire is assessed in participants and their caregivers. It captures three subscales: general fatigue, sleep/rest-related fatigue, and cognitive fatigue.
Outcome measure: Fatigue score (total and subscale scores).
Interpretation: Higher scores indicate lower fatigue.
Measured: At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Mental well-being
Assessed using the WHO-5 Well-Being Index (WHO-5). This psychometric instrument is used to measure general well-being and psychological health. The questionnaire consists of five items, each rated on a 6-point Likert scale.
Outcome measure: WHO-5 well-being sum score.
Interpretation: Higher scores indicate higher well-being.
Measured: At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Symptoms and side effects during cancer therapy
Assessed using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). The instrument is used to standardize the assessment of prevalent symptoms during cancer therapy. This questionnaire is assessed in participants and their caregivers. In the BEPPO study the following 10 items are assessed: decreased appetite, constipation, diarrhea, shortness of breath, heart palpitation, numbness \& tingling, dizziness, insomnia, falls, muscle weakness.
Outcome measure: Symptom burden (PRO-CTCAE item scores).
Interpretation: Occurance of symptomatic toxicities. Evaluation per item, higher value indicates higher severity.
Measured: At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Cost-effectiveness of BEPPO compared to standard care in terms of incremental costs per muscle strength, physical activity or health-related quality of life
Assessing the cost-effectiveness of BEPPO compared to standard care in terms of incremental costs per muscle strength, physical activity or health-related quality of life.
Measured: From baseline (T0) up to the end of the active study period (clinical follow-up at T3)
Cost-utility of BEPPO compared to standard care in terms of costs per quality-adjusted life year [QALY]
Assessing the cost-utility of BEPPO compared to standard care in terms of costs per quality-adjusted life year [QALY]
Measured: From baseline (T0) up to the end of the active study period (T3; clinical follow-up)
Implementation outcome via formative evaluation
Formative evaluation regarding the implementation will be conducted using qualitative analysis of semi-structured interviews
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start1 Jul 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Cancer PatientsStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Control Trail, two groups: one intervention group, one control group
- Masking
- None (open label)
- Enrolment
- 346 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Essen, University of Cologne, University of Regensburg, Klinik Hallerwiese-Cnopfsche Kinderklink, University Hospital Ulm, Klinikum Stuttgart, University Hospital, Bonn, Jena University Hospital, Universitätsklinikum Hamburg-Eppendorf, Johann Wolfgang Goethe University Hospital, Technical University of Munich, Children's University Hospital Cologne, Germany, Charite University, Berlin, Germany, Johannes Gutenberg University Mainz, University Hospital of Cologne, AOK Rheinland/Hamburg, Techniker Krankenkasse, BARMER Krankenkasse, DAK Gesundheit
- Responsible party
- Principal investigator, Miriam Götte, Universität Duisburg-Essen
- Investigators
- Miriam Goette, Study chair, Institut for Movement and Exercise, West German Cancer Center, University Hospital Essen, Essen, GermanyFreerk T Baumann, Study chair, Department I of Internal Medicine, Center for Integrated Oncology Cologne Bonn, University Hospital of Cologne, Cologne, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647471
- Sponsor's protocol ID
- BEPPO_01NVF24318
- Other IDs
- 01NVF24318
- Acronym
- BEPPO
- Status last verified
- Jul 2026
- First submitted
- 9 Jun 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Exercise Intervention During Intensive Medical Treatment in Pediatric Oncology (Evaluation BEwegungs- Und sPorttherapeutischer Interventionen Unter Medizinischer Therapie in Der Pädiatrischen Onkologie)
- ClinicalTrials.gov ID
- NCT07647471
- Acronym / sponsor ID
- BEPPO / BEPPO_01NVF24318
- Conditions
- Pediatric Cancer Patients
- Keywords
- Knee extensor strength, Quality of Life, Fatigue, Health economics, Implementation, Physical activity, Exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 346 participants (estimated)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Collaborators
- University Hospital, Essen, University of Cologne, University of Regensburg, Klinik Hallerwiese-Cnopfsche Kinderklink, University Hospital Ulm, Klinikum Stuttgart, University Hospital, Bonn, Jena University Hospital, Universitätsklinikum Hamburg-Eppendorf, Johann Wolfgang Goethe University Hospital, Technical University of Munich, Children's University Hospital Cologne, Germany, Charite University, Berlin, Germany, Johannes Gutenberg University Mainz, University Hospital of Cologne, AOK Rheinland/Hamburg, Techniker Krankenkasse, BARMER Krankenkasse, DAK Gesundheit
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 15 Jun 2026 (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 BEPPO study is a Germany-wide clinical trial investigating whether a structured exercise program can improve physical and mental health in children and adolescents undergoing cancer treatment. Although exercise is known to support recovery and well-being, it is not yet a standard part of pediatric oncology care. The study aims to generate evidence to support the integration of exercise into routine treatment.
A total of 346 patients aged 3 to 18 years are recruited across 13 pediatric oncology centers in Germany. Participants are randomly assigned to either an exercise intervention group or a standard care control group.
Children in the intervention group take part in a 6-month individualized exercise program with 3-5 sessions per week. The program is delivered across different settings, including inpatient hospital care, outpatient treatment, and home-based training supported by telemedicine. This ensures continuous support throughout the course of medical treatment.
In addition to supervised exercise sessions, participants receive four structured counseling sessions. These sessions aim to strengthen motivation, address individual barriers to participation, and support long-term engagement in physical activity. The counseling also helps build a strong therapeutic relationship and promotes adherence to the program.
The exercise intervention is based on established principles of sports science but is individually adapted to each patient's health status, treatment phase, and personal preferences. Each training session follows a structured plan with specific goals, while also considering individual physical and psychological conditions to ensure safety, feasibility, and effectiveness.
The main objective of the BEPPO study is to improve physical performance, particularly leg strength, which is the primary endpoint. Secondary outcomes include endurance, functional mobility, balance, physical activity levels, fatigue, quality of life, mental well-being, frailty, and treatment-related symptoms and side effects.
In addition to clinical effectiveness, the study also evaluates how well the intervention can be implemented in routine healthcare settings. This includes assessing adherence, feasibility, and potential barriers and facilitators for integrating exercise into standard care. A health economic evaluation is also conducted in collaboration with health insurance providers to determine cost implications.
Overall, the BEPPO study aims to provide robust scientific evidence on the benefits and feasibility of structured exercise during pediatric cancer treatment. The long-term goal is to establish exercise as a standard component of supportive care in pediatric oncology, improving both short- and long-term outcomes for patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Control Trail, two groups: one intervention group, one control group
| Arm | Type | Receives |
|---|---|---|
| BEPPO-group | Experimental | Behavioral: Partially-standardised, supervised, continuity-of-care exercise interventionPatients in the BEPPO group participate in 3-5 partially standardized, supervised exercise sessions per week (30 minutes each), aiming for at least 78 sessions during the 6-month intervention period. Sessions are delivered in hospital settings (inpatient ward, outpatient clinic, or day clinic) and online during periods at home. Exercises are individually adapted to age, health status, treatment phase, and interests.Primary focus are endurance and strength exercises, additionally coordination, flexibility, and balance exercises. Treatment-related side effects are continuously considered. Online sessions are delivered via video platforms; alternatively, individualized home exercise plans are provided. Additionally, patients and families participate in four family-centered exercise counselling sessions to identify barriers and facilitators to physical activity, define individualized goals, and support long-term adherence through increaseing patients intrinsic motivation. |
| Control group | No intervention | –Patients in the control group do not receive a standardized exercise intervention but may participate in the existing site-specific exercise-related usual care services offered at their respective study sites. The availability and extent of these services vary considerably across the 13 participating study sites, ranging from no exercise support to comprehensive hospital-based exercise programs during intensive cancer treatment, depending on local staffing and structural resources. Existing exercise programs are delivered exclusively within the hospital setting (inpatient ward, outpatient clinic, or day clinic) and are based on local practice rather than a standardized intervention protocol. Neither online exercise support during periods at home nor structured exercise counselling sessions are part of usual care at any participating study site. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Patients aged ≥3 and ≤18 years
- Oncological diagnosis with curative treatment intent
- ≤6 weeks since cancer diagnosis (diagnosis can be initial, secondary or relapse diagnosis)
- Information and consent procedures feasible in German, English or with using local site resources (e.g., interpreters or multilingual staff)
- Communication with the patient is possible in German, English or with using local site resources (e.g., interpreters or multilingual staff) during the assessments and intervention
Key exclusion criteria (5 listed)
- Patients aged <3 and >18 years
- No active medical oncological treatment (e.g., watch-and-wait strategy, surgery without ongoing oncological acute treatment at a pediatric oncology center)
- Medical limitations that do not allow implementation of the study protocol
- Life expectancy < 6 months
- Patients not insured by German statutory health insurers (e.g., Privatly insured patients, self-paying patients)
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 |
|---|---|---|
| Partially-standardised, supervised, continuity-of-care exercise interventionExercise sessions: 3-5x/week over 6 months (minimum of 78 sessions in total), duration: 30 minutes, partially-standardised with a primarily focus on strength and endurance exercises, additional components: coordination, flexibility, and balance exercises, supervised by exercise professionals, continuity-of-care achieved through hospital-based (in-patient/out-patient), and home-based online sessions Exercise counselling: 4x sessions in 12 months, family-centred exercise counselling, primary focus on understanding barriers and facilitators to physical activity and increasing intrinsic motivation for participating in the exercise session | Behavioural | BEPPO-group |
Primary outcome
Maximal leg extensor strength
Time frame: At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Measured using a CITEC handheld dynamometer on the dominant side unless medically contraindicated. Patients are positioned prone with the knee flexed to 90°; if lying prone is not possible for medical reasons, the assessment is performed in a seated position. The dynamometer is placed anteriorly at the distal lower leg (shin). Outcome measure: maximal muscle strength (Newton; range 0.0-500.0). Interpretation: Higher values indicate greater muscle strength.
22 secondary outcomes
Maximal handgrip strength
Time frame: At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Maximal dorsiflexor strength
Time frame: At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement
Maximal arm flexion strength
Time frame: At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Sit and Reach Test (Mobility of the torso and lower back)
Time frame: At baseline (T0), and at 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Tandem Stand (10s, eyes-open)
Time frame: At baseline (T0), and at 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Tandem Stand (10s, eyes-closed)
Time frame: At baseline (T0), and at 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Single-leg Stance (10s)
Time frame: At baseline (T0), and at 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Sit to Stand (5x STS)
Time frame: At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Timed up and go (TUG 3m)
Time frame: At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
2-Minute Walking Test (2MWT)
Time frame: At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Body Mass Index (in Percentiles)
Time frame: At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Waist-to-hip ratio (WHR)
Time frame: At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Estimate body fat and lean mass
Time frame: At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Objective physical activity
Time frame: At baseline (T0), and at 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Subjective physical activity levels
Time frame: At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Health-related quality of life
Time frame: At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Fatigue
Time frame: At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Mental well-being
Time frame: At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Symptoms and side effects during cancer therapy
Time frame: At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Cost-effectiveness of BEPPO compared to standard care in terms of incremental costs per muscle strength, physical activity or health-related quality of life
Time frame: From baseline (T0) up to the end of the active study period (clinical follow-up at T3)
Cost-utility of BEPPO compared to standard care in terms of costs per quality-adjusted life year [QALY]
Time frame: From baseline (T0) up to the end of the active study period (T3; clinical follow-up)
Implementation outcome via formative evaluation
Time frame: up to 18 months
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 11 Sep 2026.
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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.
Miriam Goette study chair
Institut for Movement and Exercise, West German Cancer Center, University Hospital Essen, Essen, Germany
Freerk T Baumann study chair
Department I of Internal Medicine, Center for Integrated Oncology Cologne Bonn, University Hospital of Cologne, Cologne, Germany
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partially-standardised, supervised, continuity-of-care exercise intervention in people with Pediatric Cancer Patients, run by Universität Duisburg-Essen at 13 sites 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 5 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: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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?
Contact Theresa Heering (0049 201 723 4948, theresa.heering@uk-essen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal leg extensor strength (time frame: At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.). 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 11 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.