Exergaming Intervention in ALL Patients

Not Applicable

Completed

• Conditions: Acute Lymphoblastic Leukemia
• Interventions: Behavioral: Exergaming Program

• Registration Number: NCT02118324
• Lead Sponsor: University of Minnesota

Brief Summary

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-26
• Study First Submitted QC: 2014-04-16
• Study First Posted: 2014-04-21
• Primary Completion: 2015-03
• Study Completion: 2016-01
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-13
• Last Update Posted: 2017-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise treatment	Exergaming Program	Participants will be instructed to use the exergaming program at home for 30 mins, 3-5 times per week.

Primary Outcome Measures

Name	Time	Method
Average minutes of physical activity per day	6-months	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.

Secondary Outcome Measures

Name	Time	Method
Average difference in visceral fat	6 months	Estimate of the likely effect size (i.e., difference between the groups in average outcome) of visceral fat.
Average difference of blood pressure	6 months	Estimate of the likely effect size (i.e., difference between the groups in average outcome) of blood pressure.
Average difference of body composition	6 months	Estimate of the likely effect size (i.e., difference between the groups in average outcome) of body composition.
Average difference in triglycerides	6 months	Estimate of the likely effect size (i.e., difference between the groups in average outcome) of triglycerides.

Trial Locations

Locations (1)

University of Minnesota Amplatz Children's Hospital; 🇺🇸 Minneapolis, Minnesota, United States