Resistance and Aerobic Exercise for Subclinical Anthracycline Cardiomyopathy
18 Years
N/A
Both
Cardiomyopathy
Trial Information
Resistance and Aerobic Exercise for Subclinical Anthracycline Cardiomyopathy
This study will evaluate the feasibility of a 12-week exercise intervention on the cardiac
function of survivors of childhood cancer treated with anthracyclines and known to have
cardiomyopathy.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
The primary aim of this proposal is to evaluate the feasibility of a 12-week exercise intervention among survivors of childhood cancer treated with anthracyclines and known to have cardiomyopathy.
Outcome Time Frame:
12 Weeks
Safety Issue:
Yes
Principal Investigator
Daniel Green, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
St. Jude Children's Research Hospital
Authority:
United States: Institutional Review Board
Study ID:
CARHAB
NCT ID:
NCT01071473
Start Date:
February 2010
Completion Date:
December 2013
Related Keywords:
- Cardiomyopathy
- Childhood cancer
- Anthracyclines
- Cardiomyopathy
- Cardiomyopathies
Name | Location |
|---|---|
| St. Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
