Exergaming Intervention in ALL Patients

Study Overview
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Brief Summary
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This is a pilot feasibility study to collect preliminary data for a large-scale exergaming intervention in children undergoing maintenance therapy for Acute Lymphoblastic Leukemia (ALL). Patients, ages 5-17 years will be randomized to the intervention or non-intervention control group. The intervention will consist of 30 minute sessions of exergaming 3-5 times a week for 6 months, with weekly assessment of exercise level and phone calls by kinesiology graduate students for safety and compliance. Physical activity at baseline and at the end of study will be assessed using accelerometers. Outcome measures will include: anthropometrics, blood pressure, body composition, visceral fat, vascular function, fasting insulin, fasting glucose, LDL-cholesterol, HDL- cholesterol, triglycerides, functional mobility and endurance, and strength.

Official Title
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The Effect of a Home-based Fitness Intervention on Cardiometabolic Risk Profile in Acute Lymphoblastic Leukemia (ALL) Patients

Conditions
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Acute Lymphoblastic Leukemia

Intervention / Treatment
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* Behavioral: Exergaming Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligibility will not be restricted by race or sex Pediatric patients with ALL diagnosis, treated at the University of Minnesota Amplatz Children's Hospital or Children's Hospitals and Clinics of Minnesota At least 3 months into the maintenance phase, with at least 6 months left of maintenance therapy Age 5-17 years at time of study enrollment Not smoking Currently not involved in a regular (3 times per week) exercise program Exclusion Criteria: Individuals with a physical or mental impairment which would preclude their ability to perform the intervention. Bone marrow transplant recipients. Any woman currently pregnant will not be eligible, but may participate 3 or more months after the end of her pregnancy if the study is still ongoing Due to the intervention being in English, non-English speakers will be excluded

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise treatment<br>Participants will be instructed to use the exergaming program at home for 30 mins, 3-5 times per week. | Behavioral: Exergaming Program<br>* Participants will exercise through exergaming play.<br>|
| No Intervention: Control group<br>No intervention is provided. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average minutes of physical activity per day | The feasibility of an exercise intervention in pediatric ALL patients undergoing maintenance therapy and its effects on markers of cardiometabolic risk. The primary outcome for this pilot study is average minutes and time spent at varying intensity of physical activity per day, as measured by accelerometers. | 6-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average difference of blood pressure | Estimate of the likely effect size (i.e., difference between the groups in average outcome) of blood pressure. | 6 months | 
| Average difference of body composition | Estimate of the likely effect size (i.e., difference between the groups in average outcome) of body composition. | 6 months | 
| Average difference in visceral fat | Estimate of the likely effect size (i.e., difference between the groups in average outcome) of visceral fat. | 6 months | 
| Average difference in triglycerides | Estimate of the likely effect size (i.e., difference between the groups in average outcome) of triglycerides. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Lymphoblastic Leukemia, ALL, fitness intervention