Exergaming Intervention in ALL Patients

NCT02118324 | Completed DMC

• 1 other identifier: 2013NTLS119
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Lymphoblastic Leukemia

Keywords

Acute Lymphoblastic Leukemia; ALL; fitness intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Average difference of blood pressure

  6 months

• Average difference of body composition

  6 months

• Average difference in visceral fat

  6 months

• Average difference in triglycerides

  6 months

Study Arms (2)

Exercise treatment

EXPERIMENTAL

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

Behavioral: Exergaming Program

Control group

NO INTERVENTION

No intervention is provided.

Interventions

Exergaming Program BEHAVIORAL

Participants will exercise through exergaming play.

Exercise treatment

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota Amplatz Children's Hospital

Minneapolis, Minnesota, 55454, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Julia Steinberger, MD, MS

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2014
• First Posted: April 21, 2014
• Study Start: March 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: January 1, 2016
• Last Updated: March 14, 2017

Record last verified: 2017-03

Locations

US (1)