Cancer Clinical Trial
Official title:
Exercise in Pediatric Autologous Stem Cell Transplant Patients: A Randomized Controlled Trial Protocol
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 is: study the effect of an exercise program on immune cell recovery in
patients undergoing autologous stem cell transplantation. The Secondary objective is to
determine if an exercise intervention might diminish the deterioration of quality of life,
physical fitness, and the acquisition of a sedentary lifestyle.
Methods
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, 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.
Discussion We expect to find an improvement in the immunological recovery, quality of life,
decreased acquisition of sedentary behavior and less fitness deconditioning.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)
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