Evaluation of an Exercise Intervention During Intensive Medical Treatment in Pediatric Oncology (Evaluation BEwegungs- Und sPorttherapeutischer Interventionen Unter Medizinischer Therapie in Der Pädiatrischen Onkologie)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 346
- 试验地点
- 13
- 主要终点
- Maximal leg extensor strength
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
BEPPO-group
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.
干预措施: Partially-standardised, supervised, continuity-of-care exercise intervention (Behavioral)
Control group
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.
结局指标
主要结局
Maximal leg extensor strength
时间窗: 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.
次要结局
- 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.)
- Tandem Stand (10s, eyes-closed)(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)(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)(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)(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)(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)(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)(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(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(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(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(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(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(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(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(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](From baseline (T0) up to the end of the active study period (T3; clinical follow-up))
- Implementation outcome via formative evaluation(up to 18 months)
研究者
Miriam Götte
PD Dr. rer. medic.
Universität Duisburg-Essen