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

BMC Cancer

Study Protocol

Faisal M Khan¹  Amanda Wurz²  Carolina Chamorro-Viña²  Tanya Williamson²  Raylene A Reimer³  S Nicole Culos-Reed⁴  Fiona Schulte⁵  Gregory MT Guilcher⁶  Karen Mazil⁷ 

[1] Department of Pathology & Laboratory, Faculty of Medicine, University of Calgary, Heritage Medical Research, 3300 Hospital Drive NW . Room 269, Calgary, Canada;Faculty of Kinesiology, University of Calgary, 2500 University Drive NW, T2N 1N4, Calgary, AB, Canada;Faculty of Kinesiology, University of Calgary, 2500 University Drive NW, T2N 1N4, Calgary, AB, Canada;Faculty of Medicine, University of Calgary, Calgary, Canada;Faculty of Kinesiology, University of Calgary, 2500 University Drive NW, T2N 1N4, Calgary, AB, Canada;Faculty of Medicine, University of Calgary, Calgary, Canada;Department of Psychosocial Resources, Tom Baker Cancer Centre, Calgary, Canada;Section of Pediatric Oncology, Alberta Children’s Hospital, Calgary, Canada;Section of Pediatric Oncology, Alberta Children’s Hospital, Calgary, Canada;Faculty of Medicine, University of Calgary, Calgary, Canada;Division of Pediatric and Oncology, Alberta Children’s Hospital, 2888 Shaganappi Trail NW, AB T3B 6A8, Calgary, Canada;Section of Pediatric Oncology, Alberta Children’s Hospital, Calgary, Canada;Hematology, Oncology, Transplant Program, Alberta Children’s Hospital, 2888 Shaganappi Trail NW44, AB T3B 6A8, Calgary, Canada;

关键词: Pediatric;    Hematopoietic stem cell transplant;    Cancer;    Exercise;    Quality of life;    Immune system;    Physical activity levels;   

DOI  :  10.1186/1471-2407-12-401

 received in 2012-08-27, accepted in 2012-08-28,  发布年份 2012

来源: Springer

【 摘 要 】

BackgroundHematopoietic 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.MethodsThis 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.DiscussionWe 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.Trial registrationGov identification # NCT01666015

【 授权许可】

Unknown   
© Chamorro et al.; licensee BioMed Central Ltd. 2012. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.