Physical Activity to Modify Sequelae and Quality of Life in Childhood Acute Lymphoblastic Leukemia

Completed · Not applicable

Conditions studied: Acute Lymphoblastic Leukemia

In brief

This will be the first multidisciplinary, randomized, longitudinal trial of a tailored, parent- and child-focused physical activity program for children (ages 4- \<19 years) with newly diagnosed ALL. It will test the ability of the intervention to prevent or diminish early physical function limitations and improve health-related quality of life (HRQL). The intervention will be tested for its effect on: 1) physical function outcomes (muscle strength, range of motion, endurance, gross motor skills), bone density and bone mineral content (end of therapy only); and 2) HRQL. This multi-site trial will test the intervention in 76 evaluable children with ALL (38 receiving the intervention and 38 receiving a placebo "minimal movement" standard care strategy).

Key facts

Study ID

NCT00902213

Run by

St. Jude Children's Research Hospital

People needed

122

Starts

2009-11-01

Expected to finish

2015-05-01

Last updated by the study team

2015-11-17

Who can join

Age: 4 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• An immunophenotypic diagnosis of non-B cell ALL
• Age 4 years through <19 years at diagnosis
• 2-8 days on or per front line ALL treatment protocol
• One parent or legal guardian (≥ 18 years) of the study subject who speaks and understands the English Language
• Participant speaks and understands the English language
• Written informed consent and child assent

You may not qualify if…

• Age < 4 years or ≥19 years at diagnosis
• A diagnosis of cerebral palsy or down syndrome
• Second malignancy, chromosome breakage syndrome, or severe congenital immunodeficiency
• Inability or unwillingness of research participant or legal guardian/representative to give written informed consent/assent
• Females who are pregnant.

Where it is running

• AFLAC Cancer Center Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• St. Jude Children's Research Hospital — Memphis, Tennessee, United States
• MD Anderson — Houston, Texas, United States
• Toronto Hospital for Sick Children — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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