Exergaming Intervention in ALL Patients

University of Minnesota35 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Acute Lymphoblastic Leukemia

Interventions

Eligibility

Sex: ALLMin age: 5 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 6-months

Secondary Outcomes

Average difference of blood pressure

Estimate of the likely effect size (i.e., difference between the groups in average outcome) of blood pressure.

Time frame: 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.

Time frame: 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.

Time frame: 6 months

Average difference in triglycerides

Estimate of the likely effect size (i.e., difference between the groups in average outcome) of triglycerides.

Time frame: 6 months

Exergaming Intervention in ALL Patients

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes