Exergaming Intervention in ALL Patients

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02118324
• Other study ID #: 2013NTLS119
• Status: Completed
• Phase: N/A
• First received: March 26, 2014
• Last updated: March 13, 2017
• Start date: March 2014
• Est. completion date: January 2016

Study information

• Verified date: March 2017
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 2016
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Behavioral:
• Exergaming Program
Participants will exercise through exergaming play.

Locations

Country	Name	City	State
United States	University of Minnesota Amplatz Children's Hospital	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Average difference in triglycerides	Estimate of the likely effect size (i.e., difference between the groups in average outcome) of triglycerides.	6 months