Physical Exercise Therapy in Pediatric Stem Cell Transplantation

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01575704

Acronym

BISON

Enrollment

Registered

2012-04-11

Start date

2011-01-31

Completion date

2013-06-30

Last updated

2015-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematopoetic Stem Cell Transplantation

Keywords

Exercise, Hematopoetic cell transplantation, Children

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.

Interventions

OTHERExercise

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

OTHERMental Training

Memorial/ mental training and relaxation, 5 times per week

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

5 Years to 25 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Muscle strength	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

Measure	Time frame	Description
Fatigue	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	daily	Hematological and immunological reconstitution
Body composition	one time per week and change between 3 months and 6 months after transplantation	Bioelectrical Impedance Analyse (BIA; Data Input GmbH)
Endurance performance	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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026