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Exercise in Pediatric Autologous Stem Cell Transplant Patients: A Randomized Controlled Trial Protocol

5 Years
18 Years
Open (Enrolling)
Cancer, Autologous Hematopoietic Stem Cell Transplantation

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Trial Information

Exercise in Pediatric Autologous Stem Cell Transplant Patients: A Randomized Controlled Trial Protocol

Inclusion Criteria:

- autologous SCT at Alberta Children`s Hospital (ACH) for malignancy

- age 5 to 18 years of age

- will be receiving myeloablative conditioning regimen

- no evidence of cardiac or pulmonary failure associated with treatment (SF≥28%, EF ≥

- no functional nor cognitive limitation that would prohibit performance of the
home-based training

- approval by treating oncologist for participants

- a parent or legal guardian must sign the consent form and

- children should express verbal assent to participate.

Exclusion Criteria:


Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Outcome Measure:

Hematological and Immunological Recovery

Outcome Description:

Assessment of the impact of the Exercise (EX) intervention on the immune recovery of pediatric autologous SCT patients will be based on four parameters (a) Recovery of different leukocyte cell subset (e.g., T cells, Natural killer cells, B cells, monocytes, neutrophils etc) in peripheral blood by flow cytometry, (b) Expression of activating and inhibitory Killer IRs by Gene expression analysis of 14 KIR genes will be done by RNA based real-time PCR analysis(c) Function of NK cells and their subsets by measuring in-vitro cytokine secretion and degranulation by different NK cell subsets (cytolytic and regulatory NK cells) on incubation with K-562 cell lines and (d) Levels of different pro-inflammatory and regulatory cytokines in serum using a bead-based array on Luminex.

Outcome Time Frame:

This assessments will be performed at baseline, 7, 14, 28, 56, 84 and 180 days after stem cell transplantation (SCT)

Safety Issue:


Principal Investigator

Nicole S Culos-Reed, Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Calgary Faculty of Kinesiology, Faculty of Medicine and Department of Psychosocial Resources, Tom Baker Cancer Centre


Canada:Alberta Children's Hospital Research Institute (ACHRI)

Study ID:




Start Date:

June 2012

Completion Date:

July 2015

Related Keywords:

  • Cancer
  • Autologous Hematopoietic Stem Cell Transplantation
  • pediatric
  • exercise
  • hematopoietic stem cell transplantation
  • cancer
  • quality of life
  • immune system
  • physical activity levels