Exercise in Pediatric Cancer Patient Undergoing Anti-Cancer Treatment

Study Overview
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Brief Summary
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Today about 80% childhood cancer patients become long-time survivors. In spite of the high cure rates the diagnosis cancer is associated with a variety of disease and treatment-related psychological and physical impairments mostly present into adulthood. So the attention has to focus on the improvement of these problems such as motor limitation, dysfunction of the cardiovascular system, reduced muscle strength, overweight, osteoporosis and diminished quality of life (Qol). Although exercisel intervention studies in this field are generally scarce, the results of these studies are promising. Up to now studies during the acute phase of treatment are missing almost completely. The aim of this feasibility study is to evaluate the potential benefits of a modular exercise intervention program for childhood cancer patients startunf in parallel with treatment and longlasting for one year. Across two years cancer patients of the Children's Hospital of the University Clinic of Heidelberg aged 5-21 years, free of any contraindications for physical activity will be recruited. All participants are asked to complete a physical assessment battery (strength, endurance and balance capacity, posture control, functional mobility, range of motion) and additionally two questionnaires concerning Qol and motivation, at baseline and every three months following one year

Official Title
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Physical Activity Intervention Program for Childhood Cancer Patients Under Chemo- and/or Radiation Therapy

Conditions
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Childhood Cancer

Intervention / Treatment
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* Behavioral: Multimodal Exercise Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pediatric cancer diagnosis (primary leukemia, brain tumors and bone tumors date of diagnosis not longer than 8 weeks ago Exclusion Criteria: severe cardiac impairment bone metastasis inducing skeletal fragility other orthopedic diseases or any other circumstance that would impede ability to give informed consent or adherence to study requirements.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Multimodal Exercise intervention (console-based training, age-specific resistance training and body awareness) | Behavioral: Multimodal Exercise Intervention<br>* During their inpatient hospitalization the participants perform 3-5x weekly guided training sessions about 15-30min. The intervention includes: game console-based training using Nintendo Wii® (endurance, strength endurance and balance), age-specific resistance training and sessions of body awareness. During the outpatient phases the participants perform a home-based exercise training 3-5x weekly using a training manual. In addition, the patients obtain a movement diary and a pedometer for documenting their activity level.<br>|
| No Intervention: Control<br>age, disease and gender matched | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility after 6 month | Will be measured as the proportion of patients following the exercise prescription. | after primary treatment (6 month) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical performance | Strength (handheld dynamometer), endurance and balance capacity (TUDS, one leg stand), postural control functional mobility (posturomed & force plate), range of motion (goniometer) | after primary treatment (6 month) and after one year | 
| Quality of Life | KINDL questionnaire | after primary treatment (6 month) and after one year | 
| Feasibility between 6 and 12 month | Will be measured as the proportion of patients following the exercise prescription. | between end of primary treatment (6 month) and one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Pediatric oncology, Physical Performance, Quality of Life, Feasibility, during primary, anticancer treatment