Effects of Resistance and Endurance Training in Pediatric Cancer Patients During Intensive Treatment Phase

Study Overview
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Brief Summary
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The purpose of this study is to determine whether combined endurance and resistance training can improve muscle strength in children and adolescents with cancer during the intensive treatment phase.

Official Title
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Effects of Combined Resistance and Endurance Training in Pediatric Cancer Patients During Intensive Treatment Phase

Conditions
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Pediatric Oncology

Intervention / Treatment
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* Behavioral: Exercise Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Malignant Tumor Medical Treatment in the Center for Pediatrics, Hematology, Oncology and Hemostaseology Mainz (Germany) > 3 years Signed Informed Consent Exclusion Criteria: Functional and/or cognitive limitations which limit performance during training Orthopedic condition which hinders to adequately participate in exercise training Heart failure (NYHA III-IV) Partial or global respiratory failure Symptomatic coronary disease Serious therapy-refractory hypertonia Sustainable thrombocytopenia <10.000/µl, f. ex. therapy-refractory autoimmune thrombocytopenia Hereditary or acquired thrombocytopenia or coagulation disturbance Uncontrolled cerebral spasm CNS metastases Medical or psychological condition which does in the doctors opinion not allow participation in sport activity

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 18 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise group<br>Exercise training during intensive medical treatment | Behavioral: Exercise Training<br>* Exercise training during intensive medical treatment. Training mainly composed of endurance and resistance exercises. 3 to 5 times per week for six weeks.<br>|
| No Intervention: Control group<br>Usual Care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength: lower limb | Lower limb muscle strength measured by the load (kg) sustained in one repetition maximum test | Six weeks (pre-post intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength: upper limb | Upper limb muscle strength measured by the load (kg) sustained in one repetition maximum test | Six weeks (pre-post intervention) | 
| Biomarker in Blood | Immune status and metabolic status | At the beginning of the intervention and three and six weeks after the beginning. Comparing the two time points inbetween study groups | 
| Body composition | Bioelectrical Impedance Analysis | Six weeks (pre-post intervention) | 
| Six-minute-walk performance |  | Six weeks (pre-post intervention) | 
| Fatigue | Pediatric Quality of Life Inventory (PedsQL) Multidimensional Fatigue Scale | six weeks (pre-post intervention) | 
| Quality of Life | KINDL: health related quality of life questionnaire | Six weeks (pre-post intervention) | 
| Cardiorespiratory performance | Ergospirometry | Six weeks (pre-post intervention) |