Exergaming Intervention in ALL Patients

University of Minnesota (UMN)

Status: Completed

Conditions: Acute Lymphoblastic Leukemia

Treatments: Behavioral: Exergaming Program

Study type: Interventional

Funder types: Other

Identifiers

NCT02118324

2013NTLS119

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

Exercise treatment

Experimental group

Description:

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

Treatment:

Behavioral: Exergaming Program

Control group

No Intervention group

Description:

No intervention is provided.