Exercise in Pediatric Autologous Stem Cell Transplant Patients (SCORE)

University of Calgary

Status

Terminated

Conditions

Cancer

Autologous Hematopoietic Stem Cell Transplantation

Treatments

Other: EXERCISE (EX)

Other: Standard Care

Study type

Interventional

Funder types

Other

Identifiers

NCT01666015

RF-CACICPES01

University of Calgary (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment

24 estimated patients

Sex

All

Ages

5 to 18 years old

Volunteers

No Healthy Volunteers

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 ≥ 50%)
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