Clinical trial · Interventional
Evaluation of an Exercise Intervention During Intensive Medical Treatment in Pediatric Oncology.
Evaluation of an Exercise Intervention During Intensive Medical Treatment in Pediatric Oncology (Evaluation BEwegungs- Und sPorttherapeutischer Interventionen Unter Medizinischer Therapie in Der Pädiatrischen Onkologie)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 12, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260912-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric Cancer Patients | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Partially-standardised, supervised, continuity-of-care exercise intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- BEPPO-group
- description
- 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.
- interventionNames
- Behavioral: Partially-standardised, supervised, continuity-of-care exercise intervention
- type
- NO_INTERVENTION
- label
- Control group
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
References
Publications (0)
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