Exergaming Intervention in ALL Patients
March 13, 2017 updated by: University of Minnesota
The Effect of a Home-based Fitness Intervention on Cardiometabolic Risk Profile in Acute Lymphoblastic Leukemia (ALL) Patients
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55454
- University of Minnesota Amplatz Children's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 13 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exercise treatment
Participants will be instructed to use the exergaming program at home for 30 mins, 3-5 times per week.
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Participants will exercise through exergaming play.
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No Intervention: Control group
No intervention is provided.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Average minutes of physical activity per day
Time Frame: 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.
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6-months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Average difference of blood pressure
Time Frame: 6 months
|
Estimate of the likely effect size (i.e., difference between the groups in average outcome) of blood pressure.
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6 months
|
|
Average difference of body composition
Time Frame: 6 months
|
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
Time Frame: 6 months
|
Estimate of the likely effect size (i.e., difference between the groups in average outcome) of visceral fat.
|
6 months
|
|
Average difference in triglycerides
Time Frame: 6 months
|
Estimate of the likely effect size (i.e., difference between the groups in average outcome) of triglycerides.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Julia Steinberger, MD, MS, University of Minnesota
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2014
Primary Completion (Actual)
March 1, 2015
Study Completion (Actual)
January 1, 2016
Study Registration Dates
First Submitted
March 26, 2014
First Submitted That Met QC Criteria
April 16, 2014
First Posted (Estimate)
April 21, 2014
Study Record Updates
Last Update Posted (Actual)
March 14, 2017
Last Update Submitted That Met QC Criteria
March 13, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013NTLS119
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.