title: EXERCISE in pediatric autologous stem cell transplant patients: a randomized controlled trial protocol.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Gov identification # NCT01666015.
authors.affiliation: Faculty of Kinesiology, University of Calgary, AB, Canada.
authors.forename: Carolina
authors.initials: C
authors.lastname: Chamorro-Viña
authors.forename: Gregory M T
authors.initials: GM
authors.lastname: Guilcher
authors.forename: Faisal M
authors.initials: FM
authors.lastname: Khan
authors.forename: Karen
authors.initials: K
authors.lastname: Mazil
authors.forename: Fiona
authors.initials: F
authors.lastname: Schulte
authors.forename: Amanda
authors.initials: A
authors.lastname: Wurz
authors.forename: Tanya
authors.initials: T
authors.lastname: Williamson
authors.forename: Raylene A
authors.initials: RA
authors.lastname: Reimer
authors.forename: S Nicole
authors.initials: SN
authors.lastname: Culos-Reed
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D016207:Cytokines / Q000097:blood; D015444:Exercise / Q000502:physiology*; D018380:Hematopoietic Stem Cell Transplantation / Q000379:methods*; D006801:Humans; D007958:Leukocyte Count; D009369:Neoplasms / Q000097:blood / Q000534:rehabilitation* / Q000601:surgery*; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D012985:Software Design; D016896:Treatment Outcome
chemical_list: D016207:Cytokines