Evaluation of an Exercise Intervention During Intensive Medical Treatment in Pediatric Oncology.

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)

Overview

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.

Interventions

• Behavioral Partially-standardised, supervised, continuity-of-care exercise intervention
  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 fo

Primary outcome measures

• 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.]

Secondary outcome measures (12)

• 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.]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

Germany · 13 centers

• Charité-Universitätsmedizin Berlin, Department of Pediatric Oncology/Hematology — Berlin
• University of Bonn Medical Center, Department of Pediatric Hematology/Oncology, — Bonn
• Children's Hospital Amsterdamer Straße, ; Clinic for Children and Youth Medicine; Departme — Cologne
• University Hospital Cologne, Department of Pediatric Oncology and Hematology, Children's H — Cologne
• University Hospital Essen, Department of Pediatric Hematology/Oncology, Center for Child a — Essen
• Universitätsmedizin Frankfurt, Department of Pediatrics, Pediatric Oncology and Haematolog — Frankfurt
• Universitätsklinikum Hamburg-Eppendorf, Department of Pediatric Hematology and Oncology, H — Hamburg
• Universitätsklinikum Jena, Klinik für Kinder- und Jugendmedizin — Jena
• … and 5 more centers

Identifiers

NCT: NCT07647471 · BEPPO_01NVF24318 · 01NVF24318

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗