Physical Exercise Therapy in Pediatric Stem Cell Transplantation (BISON)

March 31, 2015 updated by: Peter Bader, Johann Wolfgang Goethe University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Frankfurt, Hessen, Germany, 60590
        • University Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control
Other: Mental Training
Memorial/ mental training and relaxation, 5 times per week
Experimental: Sport
Other: Exercise
Supervised exercise training (aerobic, resistance, flexibility), 5 times per week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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)
change between hospital admission and discharge (approximately 4-6 weeks) and 3 months and 6 months after transplantation
Biomarker in blood
Time Frame: daily
Hematological and immunological reconstitution
daily
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)
one time per week and change between 3 months and 6 months after transplantation
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
change between hospital admission and discharge (approximately 4-6 weeks) and 3 months and 6 months after transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johann Wolfgang Goethe University Hospital

Collaborators

Institut für Sportwissenschaften, Frankfurt
Fresenius University of Applied Science

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

March 8, 2012

First Submitted That Met QC Criteria

April 10, 2012

First Posted (Estimate)

April 11, 2012

Study Record Updates

Last Update Posted (Estimate)

April 1, 2015

Last Update Submitted That Met QC Criteria

March 31, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BISON01042011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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