Physical Exercise Therapy in Pediatric Stem Cell Transplantation

Not Applicable

Completed

• Conditions: Hematopoetic Stem Cell Transplantation

• Registration Number: NCT01575704
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2012-03-08
• Study First Submitted QC: 2012-04-10
• Study First Posted: 2012-04-11
• Primary Completion: 2013-01
• Study Completion: 2013-06
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-31
• Last Update Posted: 2015-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Biomarker in blood	daily	Hematological and immunological reconstitution
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
Body composition	one time per week and change between 3 months and 6 months after transplantation	Bioelectrical Impedance Analyse (BIA; Data Input GmbH)
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)

Trial Locations

Locations (1)

University Children's Hospital; 🇩🇪 Frankfurt, Hessen, Germany