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

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. 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

• Pediatric Cancer 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 focus on understanding barriers and facilitators to physical activity and increasing intrinsic motivation for participating in the exercise session

Sponsors & Collaborators

• University Hospital, Essen

  collaborator OTHER

• University of Cologne

  collaborator OTHER

• University of Regensburg

  collaborator OTHER

• Klinik Hallerwiese-Cnopfsche Kinderklink

  collaborator UNKNOWN

• University Hospital Ulm

  collaborator OTHER

• Klinikum Stuttgart

  collaborator OTHER

• University Hospital, Bonn

  collaborator OTHER

• Jena University Hospital

  collaborator OTHER

• Universitätsklinikum Hamburg-Eppendorf

  collaborator OTHER

• Johann Wolfgang Goethe University Hospital

  collaborator OTHER

• Technical University of Munich

  collaborator OTHER

• Children's University Hospital Cologne, Germany

  collaborator OTHER

• Charite University, Berlin, Germany

  collaborator OTHER

• Johannes Gutenberg University Mainz

  collaborator OTHER

• University Hospital Cologne

  collaborator UNKNOWN

• AOK Rheinland/Hamburg

  collaborator INDUSTRY

• Techniker Krankenkasse

  collaborator OTHER

• BARMER Krankenkasse

  collaborator UNKNOWN

• DAK Gesundheit

  collaborator OTHER

• Universität Duisburg-Essen

  lead OTHER

Principal Investigators

• Miriam Goette · Institut for Movement and Exercise, West German Cancer Center, University Hospital Essen, Essen, Germany

• Freerk T Baumann · Department I of Internal Medicine, Center for Integrated Oncology Cologne Bonn, University Hospital of Cologne, Cologne, Germany

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

3 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-01

Primary Completion

2028-12-31

Completion

2028-12-31

Countries

• Germany

Study Locations