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

NCT07647471 | Not Yet Recruiting DMC

• 2 other identifiers: BEPPO_01NVF2431801NVF24318
• Study Type: interventional
• Target: 346
• Locations: 1 country
• Sites: 13

Brief 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

Keywords

Knee extensor strength; Quality of Life; Fatigue; Health economics; Implementation; Physical activity; Exercise

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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)

  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)

  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.

Study Arms (2)

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.

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.

Interventions

Partially-standardised, supervised, continuity-of-care exercise intervention BEHAVIORAL

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

BEPPO-group

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universität Duisburg-Essen: lead
• University Hospital, Essen: collaborator
• University of Cologne: collaborator
• University of Regensburg: collaborator
• Klinik Hallerwiese-Cnopfsche Kinderklink: collaborator
• University Hospital Ulm: collaborator
• Klinikum Stuttgart: collaborator
• University Hospital, Bonn: collaborator
• Jena University Hospital: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator
• Johann Wolfgang Goethe University Hospital: collaborator
• Technical University of Munich: collaborator
• Children's University Hospital Cologne, Germany: collaborator
• Charite University, Berlin, Germany: collaborator
• Johannes Gutenberg University Mainz: collaborator
• University Hospital Cologne: collaborator
• AOK Rheinland/Hamburg: collaborator
• Techniker Krankenkasse: collaborator
• BARMER Krankenkasse: collaborator
• DAK Gesundheit: collaborator

Study Sites (13)

Charité-Universitätsmedizin Berlin, Department of Pediatric Oncology/Hematology

Berlin, Germany

Location

University of Bonn Medical Center, Department of Pediatric Hematology/Oncology,

Bonn, Germany

Location

Children's Hospital Amsterdamer Straße, ; Clinic for Children and Youth Medicine; Department for pediatric hematology/oncology

Cologne, Germany

Location

University Hospital Cologne, Department of Pediatric Oncology and Hematology, Children's Hospital

Cologne, Germany

Location

University Hospital Essen, Department of Pediatric Hematology/Oncology, Center for Child and Adolescent Medicine, Clinic for Pediatrics III

Essen, Germany

Location

Universitätsmedizin Frankfurt, Department of Pediatrics, Pediatric Oncology and Haematology

Frankfurt, Germany

Location

Universitätsklinikum Hamburg-Eppendorf, Department of Pediatric Hematology and Oncology, Hubertus Wald Tumor Center, University Cancer Center Hamburg

Hamburg, Germany

Location

Universitätsklinikum Jena, Klinik für Kinder- und Jugendmedizin

Jena, Germany

Location

Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Department of Pediatric Hematology/Oncology

Mainz, Germany

Location

Pädiatrische Hämatologie und Onkologie, Zelltherapie Zentrum für Kinder- und Jugendmedizin Eine Kooperation der München Klinik und des TUM Klinikums

München, Germany

Location

DIAKONEO Klinik Hallerwiese-Cnopfsche Kinderklinik Nürnberg, Department of Pediatric Hematology and Oncology

Nuremberg, Germany

Location

Klinikum der Landeshauptstadt Stuttgart, Zentrum für Kinder-, Jugend- und Frauenmedizin, Pädiatrie

Stuttgart, Germany

Location

University Medical Center Ulm, Department of Pediatrics and Adolescent Medicine

Ulm, Germany

Location

MeSH Terms

Conditions

Fatigue; Motor Activity

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Miriam Goette

  Institut for Movement and Exercise, West German Cancer Center, University Hospital Essen, Essen, Germany

  STUDY CHAIR

• Freerk T Baumann

  Department I of Internal Medicine, Center for Integrated Oncology Cologne Bonn, University Hospital of Cologne, Cologne, Germany

  STUDY CHAIR

Central Study Contacts

Theresa Heering

CONTACT

0049 201 723 4948; theresa.heering@uk-essen.de

Annika Tomanek

CONTACT

0049 201 723 4898; annika.tomanek@uk-essen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. rer. medic.

Model Details: Randomized Control Trail, two groups: one intervention group, one control group

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 15, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 15, 2026

Record last verified: 2026-06

Locations

DE (13)