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

Abstract

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

Motor performance in children and adolescents with cancer at the end of acute treatment phase

“…Specific physical therapy, adapted to individual performance limitations, is essential for this patient group, as well as a general promotion of enjoyable exercises to maintain adequate activity levels and physical fitness [40]. Some ongoing studies about the role of exercise interventions in specific groups of pediatric cancer entities like solid tumors [33] and patients treated with autologous stem cell transplantation [7] may help to develop entity-related exercise recommendations in the future.…”

Rehabilitative intervention during and after pediatric hematopoietic stem cell transplantation: An analysis of the existing literature

“…There are three studies on exercise programs during hospitalization: they are a RCT, a controlled clinical trial, and a case–control study . (Table )…”

“…One study had the objective of evaluating effects of an exercise program during both inpatient and outpatient phases on immune recovery and prevention of QoL and physical fitness decline. The sample included 24 patients (5–18 years) undergoing autologous HSCT (auto‐HSCT).…”

Active video games to promote physical activity in children with cancer: a randomized clinical trial with follow-up

“…Active video games have been studied also in children with cerebral palsy [ 35 , 36 ], developmental delay [ 37 ] or disability [ 38 ], acquired brain injury [ 39 ] and lower limb amputations [ 40 ] with promising results [ 30 ] but, to the best of our knowledge, active video games have not yet been studied in children with cancer alone. However, there is a protocol published in which active video gaming is used for exercise purposes in pediatric autologous stem cell transplant patients [ 41 ].…”