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Physical Exercise Therapy in Pediatric Stem Cell Transplantation (BISON)

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ClinicalTrials.gov Identifier: NCT01575704
Recruitment Status : Completed
First Posted : April 11, 2012
Last Update Posted : April 1, 2015
Sponsor:
Collaborators:
Institut für Sportwissenschaften, Frankfurt
Fresenius University of Applied Science
Information provided by (Responsible Party):
Peter Bader, Johann Wolfgang Goethe University Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Hematopoetic Stem Cell Transplantation Other: Exercise Other: Mental Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Physical Exercise Therapy in Pediatric Stem Cell Transplantation (BISON- Bewegungstherapie in Der Pädiatrischen Stammzelltransplantation)
Study Start Date : January 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sport Other: Exercise
Supervised exercise training (aerobic, resistance, flexibility), 5 times per week

Control Other: Mental Training
Memorial/ mental training and relaxation, 5 times per week




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


Secondary Outcome Measures :
  1. Fatigue [ Time Frame: change between hospital admission and discharge (approximately 4-6 weeks) and 3 months and 6 months after transplantation ]
    Pediatric Quality of Life Inventory (PedsQL)

  2. Biomarker in blood [ Time Frame: daily ]
    Hematological and immunological reconstitution

  3. Body composition [ Time Frame: one time per week and change between 3 months and 6 months after transplantation ]
    Bioelectrical Impedance Analyse (BIA; Data Input GmbH)

  4. Endurance performance [ Time Frame: change between hospital admission and discharge (approximately 4-6 weeks) and 3 months and 6 months after transplantation ]
    6-Minute-Walking-Test (6MWT); Ergospirometry and Echocardiography



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01575704


Locations
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Germany
University Children's Hospital
Frankfurt, Hessen, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Institut für Sportwissenschaften, Frankfurt
Fresenius University of Applied Science
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Peter Bader, Head Department of Stem Cell Transplantation and Immunology, Johann Wolfgang Goethe University Hospital
ClinicalTrials.gov Identifier: NCT01575704    
Other Study ID Numbers: BISON01042011
First Posted: April 11, 2012    Key Record Dates
Last Update Posted: April 1, 2015
Last Verified: March 2015
Keywords provided by Peter Bader, Johann Wolfgang Goethe University Hospital:
Exercise
Hematopoetic cell transplantation
Children