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Completed

NCT Number: NCT02118324

Exergaming Intervention in 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.

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Key information

Conditions

Acute Lymphoblastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota Amplatz Children's Hospital

Minneapolis, Minnesota, 55454, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exergaming Program

Behavioral

Participants will exercise through exergaming play.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Apr 21, 2014
Registry last updated
Mar 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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