Resistance and Aerobic Exercise for Subclinical Anthracycline Cardiomyopathy

Completed · Not applicable

Conditions studied: Cardiomyopathy

In brief

This application proposes a prospective, single arm feasibility clinical 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. 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.

Key facts

Study ID

NCT01071473

Run by

St. Jude Children's Research Hospital

People needed

22

Starts

2010-02-01

Expected to finish

2012-10-01

Last updated by the study team

2014-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Treated at St. Jude Children's Research Hospital (SJCRH)
• 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

You may not qualify if…

• Ejection fraction ≤ 40%
• 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

Where it is running

• St. Jude Children's Research Hospital — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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