Aerobic and Strengthening Exercise for Acute Leukemia

NCT00766311 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2012-01-09

No results posted yet for this study

Summary

Survivors of childhood leukemia have muscle weakness and impaired mobility (physical performance), a higher than expected frequency of obesity, and early mortality from cardiovascular disease. Treatment related neuropathy, cardiotoxicity and general cachexia may complicate physical performance and establish a pattern of sedentary behavior that may lead to a lifetime of inactivity. There is limited evidence that children being treated for leukemia benefit from home exercise programs during the maintenance phase of therapy, particularly in terms of muscle strength and range of motion. However, there are no established guidelines regarding the prescription of exercise for children diagnosed with leukemia. We propose to test the feasibility of an exercise intervention among children being treated for acute lymphoblastic leukemia (ALL) and hypothesize that children who participate in the exercise intervention will demonstrate improvements in gross motor function, strength, flexibility, and cardio respiratory fitness, and that they will have more favorable body composition when compared to the children who are assigned to the usual activity group.

Conditions

Interventions

OTHER

Gross Motor Function

The Bruinicks-Osteretsky Test of Motor Proficiency Version 2 (BOT-2) will be used to measure participants' motor function. The test is norm- referenced and designed to test motor function in children and adolescents 4 -21 years of age. The motor composite score describes overall motor abilities and is comprised of fine motor control, manual coordination, body coordination, and strength and agility. We will use the total motor composite to describe overall motor function.

OTHER

Knee extension strength

Maximum isometric knee extension strength will be measured with the subject seated in an adjustable straight-back chair. The pelvis will be fixed by an adjustable strap and the knee flexed to 45 degrees. The participant will exert a maximal voluntary force until their contraction is "broken."

OTHER

Hand grip strength

Hand grip strength in kilograms will be measured using a Jamar hand held dynamometer (Sammons Preston Rolyan, Nottinghamshire, UK). Participants will be seated with the shoulder at 0-10 degrees and the elbow in 90 degrees of flexion. The forearm will be positioned in neutral. Each participant will complete three trials, and the average used for analysis.

OTHER

Flexibility

Flexibility will be measured by having the participant perform the sit and reach test. A yardstick is placed on a firm flat surface and tape is placed across it at a right angle to the 15 inch mark. The participant sits with the yardstick between the legs with legs extended at right angles to the taped line on the floor. The heels of the feet touch the edge of the taped line and are 10-12 inches apart. The participant reaches forward with both hands as far as possible, keeping the hands parallel. The best value for three trials, in centimeters, at the most distant point of the fingertips is recorded.

OTHER

Ankle range of motion

Ankle dorsiflexion active and passive range of motion will be measured with a goniometer. The goniometer is a reliable and valid measure of active and passive range of motion if the rater uses standard procedures

OTHER

Aerobic capacity

Participants will complete the modified Cooper test where they walk in a corridor as fast as possible for six minutes. The distance is recorded in meters and can also be used to estimate peak V02

OTHER

Body composition and vital signs

Height, body mass index, waist circumference, and blood pressure will be measured.

Sponsors & Collaborators

Principal Investigators

  • Kirsten Ness, PT, PhD · St. Jude Children's Research Hospital

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00766311 on ClinicalTrials.gov