Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Physical Exercise Therapy in Pediatric Stem Cell Transplantation (BISON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE March 8, 2012
First Posted Date  ICMJE April 11, 2012
Last Update Posted Date April 1, 2015
Study Start Date  ICMJE January 2011
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2012)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2012)
  • 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)
  • Biomarker in blood [ Time Frame: daily ]
    Hematological and immunological reconstitution
  • 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)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2012)
  • 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)
  • Biomarker in blood [ Time Frame: During intervention ]
    Hematological and immunological reconstitution
  • Body composition [ Time Frame: During intervention and change between 3 months and 6 months after transplantation ]
    Bioelectrical Impedance Analyse (BIA; Data Input GmbH)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Physical Exercise Therapy in Pediatric Stem Cell Transplantation
Official Title  ICMJE Physical Exercise Therapy in Pediatric Stem Cell Transplantation (BISON- Bewegungstherapie in Der Pädiatrischen Stammzelltransplantation)
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Hematopoetic Stem Cell Transplantation
Intervention  ICMJE
  • Other: Exercise
    Supervised exercise training (aerobic, resistance, flexibility), 5 times per week
  • Other: Mental Training
    Memorial/ mental training and relaxation, 5 times per week
Study Arms  ICMJE
  • Experimental: Sport
    Intervention: Other: Exercise
  • Control
    Intervention: Other: Mental Training
Publications * Senn-Malashonak A, Wallek S, Schmidt K, Rosenhagen A, Vogt L, Bader P, Banzer W. Psychophysical effects of an exercise therapy during pediatric stem cell transplantation: a randomized controlled trial. Bone Marrow Transplant. 2019 Nov;54(11):1827-1835. doi: 10.1038/s41409-019-0535-z. Epub 2019 May 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: April 10, 2012)
68
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01575704
Other Study ID Numbers  ICMJE BISON01042011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Peter Bader, Johann Wolfgang Goethe University Hospital
Study Sponsor  ICMJE Johann Wolfgang Goethe University Hospital
Collaborators  ICMJE
  • Institut für Sportwissenschaften, Frankfurt
  • Fresenius University of Applied Science
Investigators  ICMJE Not Provided
PRS Account Johann Wolfgang Goethe University Hospital
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP