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Completed

NCT Number: NCT01575704

Physical Exercise Therapy in Pediatric Stem Cell Transplantation

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.

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Key information

Conditions

Hematopoetic Stem Cell Transplantation Behavior Motor Activity

Age range

5 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Children's Hospital

Frankfurt am Main, Hesse, 60590, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Other

Supervised exercise training (aerobic, resistance, flexibility), 5 times per week

Mental training

Other

Memorial/ mental training and relaxation, 5 times per week

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Johann Wolfgang Goethe University Hospital

Other

Collaborators

  • Fresenius University of Applied Science
  • Institut für Sportwissenschaften, Frankfurt

Registry information

Official study title

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

Acronym: BISON

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 11, 2012
Registry last updated
Apr 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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