NCT01575704

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 11, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

April 1, 2015

Status Verified

March 1, 2015

Enrollment Period

2 years

First QC Date

March 8, 2012

Last Update Submit

March 31, 2015

Conditions

Hematopoetic Stem Cell Transplantation

Keywords

ExerciseHematopoetic cell transplantationChildren

Outcome Measures

Primary Outcomes (1)

  • Muscle strength

    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 Outcomes (4)

  • Fatigue

    change between hospital admission and discharge (approximately 4-6 weeks) and 3 months and 6 months after transplantation

  • Biomarker in blood

    daily

  • Body composition

    one time per week and change between 3 months and 6 months after transplantation

  • Endurance performance

    change between hospital admission and discharge (approximately 4-6 weeks) and 3 months and 6 months after transplantation

Study Arms (2)

Sport

EXPERIMENTAL
Other: Exercise

Control

OTHER
Other: Mental Training

Interventions

ExerciseOTHER

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

Sport
Mental TrainingOTHER

Memorial/ mental training and relaxation, 5 times per week

Control

Eligibility Criteria

Age5 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Indication for hsct
  • Informed consent signed

You may not qualify if:

  • Contraindication for exercise
  • Age \< 5 years
  • Insuperable language barrier
  • Orthopeadical, cardiological or neurological indication for physical therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Children's Hospital

Frankfurt am Main, Hesse, 60590, Germany

Location

Related Publications (1)

  • 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.

    PMID: 31089282DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head Department of Stem Cell Transplantation and Immunology

Study Record Dates

First Submitted

March 8, 2012

First Posted

April 11, 2012

Study Start

January 1, 2011

Primary Completion

January 1, 2013

Study Completion

June 1, 2013

Last Updated

April 1, 2015

Record last verified: 2015-03

Locations

DE(1)