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Sponsored by: |
St. Jude Children's Research Hospital |
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Information provided by: | St. Jude Children's Research Hospital |
ClinicalTrials.gov Identifier: | NCT00766311 |
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.
Condition | Intervention |
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Acute Lymphoblastic Leukemia |
Other: Gross Motor Function Other: Knee extension strength Other: Hand grip strength Other: Flexibility Other: Ankle range of motion Other: Aerobic capacity Other: Body compositon and vital signs |
Study Type: | Interventional |
Study Design: | Supportive Care, Open Label, Single Group Assignment |
Official Title: | Aerobic and Strengthening Exercise for Acute Leukemia |
Estimated Enrollment: | 20 |
Study Start Date: | January 2008 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
This single-arm feasibility trial will evaluate the administration of an aggressive exercise regimen.
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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 compositon and vital signs
Height, body mass index, waist circumference, and blood pressure will be measured.
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Ages Eligible for Study: | 5 Years to 10 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kirsten Ness, PT,PhD | 866-278-5833 | info@stjude.org |
United States, Minnesota | |
University of Minnesota | Not yet recruiting |
Minneapolis, Minnesota, United States, 55404 | |
Contact: Joseph Neglia, MD, MPH 612-813-5940 | |
Principal Investigator: Joseph Neglia, MD, MPH | |
United States, Oregon | |
Oregon Health and Science University | Not yet recruiting |
Portland, Oregon, United States, 97239 | |
Contact: Linda Stork, MD 503-494-1543 | |
Principal Investigator: Linda Stork, MD | |
United States, Pennsylvania | |
The Children's Hospital of Philadelphia | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Jill Ginsberg, MD 215-590-1000 | |
Principal Investigator: Jill Ginsberg, MD | |
United States, Tennessee | |
St. Jude Children's Research Hospital | Recruiting |
Memphis, Tennessee, United States, 38105 | |
Contact: Kirsten Ness, PT, PhD 866-278-5833 info@stjude.org | |
Principal Investigator: Kirsten Ness, PT, PhD |
Principal Investigator: | Kirsten Ness, PT, PhD | St. Jude Children's Research Hospital |
Responsible Party: | St. Jude Children's Research Hospital ( Kirsten Ness, PT, PhD ) |
Study ID Numbers: | XRCISL |
Study First Received: | October 1, 2008 |
Last Updated: | October 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00766311 |
Health Authority: | United States: Institutional Review Board |
Lymphatic Diseases Leukemia Leukemia, Lymphoid Immunoproliferative Disorders |
Precursor Cell Lymphoblastic Leukemia-Lymphoma Lymphoproliferative Disorders Lymphoma |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |