Physical Exercise Therapy in Pediatric Stem Cell Transplantation

Study Overview
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Brief Summary
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The purpose of this randomized controlled two-part study examines the effects of a structured sports intervention before, during and after hematopoetic stem cell transplantation (hsct) in children and adolescents. The main aspects in the sports groups are resistance, endurance and flexibility training. The control group performs a mental training as well as relaxation exercises.

Official Title
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Physical Exercise Therapy in Pediatric Stem Cell Transplantation (BISON- Bewegungstherapie in Der Pädiatrischen Stammzelltransplantation)

Conditions
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Hematopoetic Stem Cell Transplantation

Intervention / Treatment
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* Other: Exercise
* Other: Mental Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Indication for hsct Informed consent signed Exclusion Criteria: Contraindication for exercise Age < 5 years Insuperable language barrier Orthopeadical, cardiological or neurological indication for physical therapy

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 25 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: Sport<br> | Other: Exercise<br>* Supervised exercise training (aerobic, resistance, flexibility), 5 times per week<br>|
| Other: Control<br> | Other: Mental Training<br>* Memorial/ mental training and relaxation, 5 times per week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength | Upper limb: hand grip strength with JAMAR dynamometry; Lower limb: maximal isometric voluntary strength of M. quadriceps femoris | change between hospital admission and discharge (approximately 4-6 weeks) and 3 months and 6 months after transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue | Pediatric Quality of Life Inventory (PedsQL) | change between hospital admission and discharge (approximately 4-6 weeks) and 3 months and 6 months after transplantation | 
| Biomarker in blood | Hematological and immunological reconstitution | daily | 
| Body composition | Bioelectrical Impedance Analyse (BIA; Data Input GmbH) | one time per week and change between 3 months and 6 months after transplantation | 
| Endurance performance | 6-Minute-Walking-Test (6MWT); Ergospirometry and Echocardiography | change between hospital admission and discharge (approximately 4-6 weeks) and 3 months and 6 months after transplantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Hematopoetic cell transplantation, Children