EXERCISE in pediatric autologous stem cell transplant patients: a randomized controlled trial protocol

<p>Abstract</p> <p>Background</p> <p>Hematopoietic stem cell transplantation is an intensive therapy used to improve survivorship and cure various oncologic diseases. However, this therapy is associated with high mortality rates and numerous negative side-effects. The r...

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Main Authors: Chamorro-Viña Carolina, Guilcher Gregory MT, Khan Faisal M, Mazil Karen, Schulte Fiona, Wurz Amanda, Williamson Tanya, Reimer Raylene A, Culos-Reed S Nicole
Format: Article
Language:English
Published: BMC 2012-09-01
Series:BMC Cancer
Subjects:
Online Access:http://www.biomedcentral.com/1471-2407/12/401
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author Chamorro-Viña Carolina
Guilcher Gregory MT
Khan Faisal M
Mazil Karen
Schulte Fiona
Wurz Amanda
Williamson Tanya
Reimer Raylene A
Culos-Reed S Nicole
author_facet Chamorro-Viña Carolina
Guilcher Gregory MT
Khan Faisal M
Mazil Karen
Schulte Fiona
Wurz Amanda
Williamson Tanya
Reimer Raylene A
Culos-Reed S Nicole
author_sort Chamorro-Viña Carolina
collection DOAJ
description <p>Abstract</p> <p>Background</p> <p>Hematopoietic stem cell transplantation is an intensive therapy used to improve survivorship and cure various oncologic diseases. However, this therapy is associated with high mortality rates and numerous negative side-effects. The recovery of the immune system is a special concern and plays a key role in the success of this treatment. In healthy populations it is known that exercise plays an important role in immune system regulation, but little is known about the role of exercise in the hematological and immunological recovery of children undergoing hematopoietic stem cell transplant. The primary objective of this randomized-controlled trial (RCT) is to study the effect of an exercise program (in- and outpatient) on immune cell recovery in patients undergoing an autologous stem cell transplantation. The secondary objective is to determine if an exercise intervention diminishes the usual deterioration in quality of life, physical fitness, and the acquisition of a sedentary lifestyle.</p> <p>Methods</p> <p>This RCT has received approval from The Conjoint Health Research Ethics Board (CHREB) of the University of Calgary (Ethics ID # E-24476). Twenty-four participants treated for a malignancy with autologous stem cell transplant (5 to 18 years) in the Alberta Children’s Hospital will be randomly assigned to an exercise or control group. The exercise group will participate in a two-phase exercise intervention (in- and outpatient) from hospitalization until 10 weeks after discharge. The exercise program includes strength, flexibility and aerobic exercise. During the inpatient phase this program will be performed 5 times/week and will be supervised. The outpatient phase will combine a supervised session with two home-based exercise sessions with the use of the Wii device. The control group will follow the standard protocol without any specific exercise program. A range of outcomes, including quantitative and functional recovery of immune system, cytokine levels in serum, natural killer (NK) cells and their subset recovery and function, and gene expression of activating and inhibitory NK cell receptors, body composition, nutrition, quality of life, fatigue, health-related fitness assessment and physical activity levels will be examined, providing the most comprehensive assessment to date.</p> <p>Discussion</p> <p>We expect to find improvements in immunological recovery and quality of life, and decreased acquisition of sedentary behavior and fitness deconditioning. The comprehensive outcomes generated in this RCT will provide preliminary data to conduct a multisite study that will generate stronger outcomes.</p> <p>Trial registration</p> <p>Gov identification # NCT01666015</p>
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spelling doaj.art-d2658d594671461bbdbad91ce842cc712022-12-21T21:49:12ZengBMCBMC Cancer1471-24072012-09-0112140110.1186/1471-2407-12-401EXERCISE in pediatric autologous stem cell transplant patients: a randomized controlled trial protocolChamorro-Viña CarolinaGuilcher Gregory MTKhan Faisal MMazil KarenSchulte FionaWurz AmandaWilliamson TanyaReimer Raylene ACulos-Reed S Nicole<p>Abstract</p> <p>Background</p> <p>Hematopoietic stem cell transplantation is an intensive therapy used to improve survivorship and cure various oncologic diseases. However, this therapy is associated with high mortality rates and numerous negative side-effects. The recovery of the immune system is a special concern and plays a key role in the success of this treatment. In healthy populations it is known that exercise plays an important role in immune system regulation, but little is known about the role of exercise in the hematological and immunological recovery of children undergoing hematopoietic stem cell transplant. The primary objective of this randomized-controlled trial (RCT) is to study the effect of an exercise program (in- and outpatient) on immune cell recovery in patients undergoing an autologous stem cell transplantation. The secondary objective is to determine if an exercise intervention diminishes the usual deterioration in quality of life, physical fitness, and the acquisition of a sedentary lifestyle.</p> <p>Methods</p> <p>This RCT has received approval from The Conjoint Health Research Ethics Board (CHREB) of the University of Calgary (Ethics ID # E-24476). Twenty-four participants treated for a malignancy with autologous stem cell transplant (5 to 18 years) in the Alberta Children’s Hospital will be randomly assigned to an exercise or control group. The exercise group will participate in a two-phase exercise intervention (in- and outpatient) from hospitalization until 10 weeks after discharge. The exercise program includes strength, flexibility and aerobic exercise. During the inpatient phase this program will be performed 5 times/week and will be supervised. The outpatient phase will combine a supervised session with two home-based exercise sessions with the use of the Wii device. The control group will follow the standard protocol without any specific exercise program. A range of outcomes, including quantitative and functional recovery of immune system, cytokine levels in serum, natural killer (NK) cells and their subset recovery and function, and gene expression of activating and inhibitory NK cell receptors, body composition, nutrition, quality of life, fatigue, health-related fitness assessment and physical activity levels will be examined, providing the most comprehensive assessment to date.</p> <p>Discussion</p> <p>We expect to find improvements in immunological recovery and quality of life, and decreased acquisition of sedentary behavior and fitness deconditioning. The comprehensive outcomes generated in this RCT will provide preliminary data to conduct a multisite study that will generate stronger outcomes.</p> <p>Trial registration</p> <p>Gov identification # NCT01666015</p>http://www.biomedcentral.com/1471-2407/12/401PediatricHematopoietic stem cell transplantCancerExerciseQuality of lifeImmune systemPhysical activity levels
spellingShingle Chamorro-Viña Carolina
Guilcher Gregory MT
Khan Faisal M
Mazil Karen
Schulte Fiona
Wurz Amanda
Williamson Tanya
Reimer Raylene A
Culos-Reed S Nicole
EXERCISE in pediatric autologous stem cell transplant patients: a randomized controlled trial protocol
BMC Cancer
Pediatric
Hematopoietic stem cell transplant
Cancer
Exercise
Quality of life
Immune system
Physical activity levels
title EXERCISE in pediatric autologous stem cell transplant patients: a randomized controlled trial protocol
title_full EXERCISE in pediatric autologous stem cell transplant patients: a randomized controlled trial protocol
title_fullStr EXERCISE in pediatric autologous stem cell transplant patients: a randomized controlled trial protocol
title_full_unstemmed EXERCISE in pediatric autologous stem cell transplant patients: a randomized controlled trial protocol
title_short EXERCISE in pediatric autologous stem cell transplant patients: a randomized controlled trial protocol
title_sort exercise in pediatric autologous stem cell transplant patients a randomized controlled trial protocol
topic Pediatric
Hematopoietic stem cell transplant
Cancer
Exercise
Quality of life
Immune system
Physical activity levels
url http://www.biomedcentral.com/1471-2407/12/401
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