Resistance and Aerobic Exercise for Subclinical Anthracycline Cardiomyopathy
NCT ID: NCT01071473
Last Updated: 2014-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2010-02-28
2012-10-31
Brief Summary
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Baseline and post intervention imaging, laboratory, and neuropsychological evaluations will be used to determine the effects of the intervention on body composition, serum lipid profile, exercise tolerance, and neurocognitive functioning. Participants will be called weekly to monitor compliance with the intervention. Incentives will be given at intervals during the trial to optimize compliance with the intervention.
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Detailed Description
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As a secondary objective, the study will document the effect of a 12-week exercise intervention on exercise tolerance, as determined by measurement of peak VO2 and peak exercise workload, shortening fraction, ejection fraction, and left ventricular wall thickness, and assess the impact of the intervention on neurocognitive functioning in survivors of childhood cancer treated with anthracyclines and known to have cardiomyopathy.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Exercise Group
Survivors of childhood cancer treated with anthracyclines and known to have cardiomyopathy will participate in a 12 week exercise intervention.
12 Week Exercise Intervention
Trial of a 12-week period of combined endurance and resistance training in survivors of childhood cancer who were treated with doxorubicin and/or daunorubicin and have impaired cardiac function.
Interventions
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12 Week Exercise Intervention
Trial of a 12-week period of combined endurance and resistance training in survivors of childhood cancer who were treated with doxorubicin and/or daunorubicin and have impaired cardiac function.
Eligibility Criteria
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Inclusion Criteria
* Ages 0 - 17 years at time of treatment
* Treated for any type of cancer
* ≥ 10 years from date of diagnosis
* ≥ 2 years after completion of active cancer therapy
* ≥ 18 years of age
* Treated with doxorubicin and/or daunorubicin (any cumulative dose)
* Ejection fraction of \< 55% without medications
* Does not currently meet the Centers for Disease Control (CDC) recommendations for exercise for adults
Exclusion Criteria
* Pregnant females (Positive Urine pregnancy Test).
* History of congenital heart disease
* History of myocardial infarction
* History of acute coronary syndrome
* Individuals with pacemakers or implanted defibrillators
* History of radiation therapy that included any part of the heart
* ≥1-mm J-point depression (depression measured 80 msec after J-point) with ST segment flat or down-sloping in the majority of complexes in any ECG lead except AVR with exercise testing.
* All patients will be classified using the recommendations of the American Heart Association. Patients found to be in Class A, C or Class D will not be eligible for study
18 Years
ALL
No
Sponsors
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St. Jude Children's Research Hospital
OTHER
Responsible Party
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Principal Investigators
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Daniel Green, MD
Role: PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
Locations
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St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Countries
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Related Links
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St. Jude Children's Research Hospital
Other Identifiers
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CARHAB
Identifier Type: -
Identifier Source: org_study_id
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