Please select the eligibility criteria that correspond to the clinical trial below.
Title: Exercise in Pediatric Autologous Stem Cell Transplant Patients: A Randomized Controlled Trial Protocol
Brief Summary: 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.


Options:
A: Inclusion Criteria:

* 7 - 18 years old
* survived childhood acute lymphoblastic leukemia (defined as being off treatment for at least 2 years)
* greater than or equal to 85th percentile BMI-for-age and gender)
* read and speak English
* have a parent that reads and speaks English or Spanish
* willingness to attend assessments
* access to the Internet

Exclusion Criteria:

* any comorbidities of obesity that require immediate sub-specialist referral including pseudotumor cerebri, sleep apnea, and obesity hypoventilation syndrome
* any subject with a known disease of the liver, pancreas or small intestine that would adversely effect digestion or absorption of nutrients
* any pulmonary, cardiovascular, orthopedic, or musculoskeletal problem that would limit ability to adhere to moderate-level physical activity recommendations
* have a history of substance abuse or other psychiatric disorder that would impair compliance with the study protocol
* are using any medications which alter body weight
* are currently enrolled in another weight loss program
* in foster care
B: Inclusion Criteria:

* cancer diagnose
* treated with Vincristine in Turku University Hospital or Tampere University Hospital

Exclusion Criteria:

* other diseases limiting functional ability
* not able to communicate
C: 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:

-
D: Inclusion Criteria:

* solitary or multiple vertebral metastases
* thoracic spine
* lumbar spine
* sacrum
* indication for palliative radiation therapy
* age: 18 - 80 years
* Karnofsky index \> 70%
* bisphosphonate therapy inititated

Exclusion Criteria:

* bony metastases of cervical spine or pelvis
* impending fracture
* other serious illnesses or medical conditions: therapy-refractory unstable heart disease, congestive heart failure NYHA °III and °IV; coagulopathies
* Significant neurological or psychiatric condition including dementia or seizures or other serious medical condition prohibiting the patient's participation in the trial by judgement of the investigators
* Legal incapacity or limited legal capacity
* Positive serum/ urine beta-HCG/ pregnancy

Answer: C