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Exergaming Intervention in ALL Patients

Primary Purpose

Acute Lymphoblastic Leukemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exergaming Program
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Lymphoblastic Leukemia focused on measuring Acute Lymphoblastic Leukemia, ALL, fitness intervention

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Minnesota Amplatz Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise treatment

Control group

Arm Description

Participants will be instructed to use the exergaming program at home for 30 mins, 3-5 times per week.

No intervention is provided.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
March 26, 2014
Last Updated
March 13, 2017
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT02118324
Brief Title
Exergaming Intervention in ALL Patients
Official Title
The Effect of a Home-based Fitness Intervention on Cardiometabolic Risk Profile in Acute Lymphoblastic Leukemia (ALL) Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia
Keywords
Acute Lymphoblastic Leukemia, ALL, fitness intervention

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise treatment
Arm Type
Experimental
Arm Description
Participants will be instructed to use the exergaming program at home for 30 mins, 3-5 times per week.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention is provided.
Intervention Type
Behavioral
Intervention Name(s)
Exergaming Program
Intervention Description
Participants will exercise through exergaming play.
Primary Outcome Measure Information:
Title
Average minutes of physical activity per day
Description
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 Outcome Measure Information:
Title
Average difference of blood pressure
Description
Estimate of the likely effect size (i.e., difference between the groups in average outcome) of blood pressure.
Time Frame
6 months
Title
Average difference of body composition
Description
Estimate of the likely effect size (i.e., difference between the groups in average outcome) of body composition.
Time Frame
6 months
Title
Average difference in visceral fat
Description
Estimate of the likely effect size (i.e., difference between the groups in average outcome) of visceral fat.
Time Frame
6 months
Title
Average difference in triglycerides
Description
Estimate of the likely effect size (i.e., difference between the groups in average outcome) of triglycerides.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia Steinberger, MD, MS
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota Amplatz Children's Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States

12. IPD Sharing Statement

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Exergaming Intervention in ALL Patients

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