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Resistance and Aerobic Exercise for Subclinical Anthracycline Cardiomyopathy

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ClinicalTrials.gov Identifier: NCT01071473
Recruitment Status : Completed
First Posted : February 19, 2010
Last Update Posted : February 10, 2014
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Tracking Information
First Submitted Date  ICMJE February 17, 2010
First Posted Date  ICMJE February 19, 2010
Last Update Posted Date February 10, 2014
Study Start Date  ICMJE February 2010
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 18, 2010)
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. [ Time Frame: 12 Weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Resistance and Aerobic Exercise for Subclinical Anthracycline Cardiomyopathy
Official Title  ICMJE Resistance and Aerobic Exercise for Subclinical Anthracycline Cardiomyopathy
Brief Summary

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.

Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Cardiomyopathy
Intervention  ICMJE Other: 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.
Study Arms  ICMJE Exercise Group
Survivors of childhood cancer treated with anthracyclines and known to have cardiomyopathy will participate in a 12 week exercise intervention.
Intervention: Other: 12 Week Exercise Intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 6, 2014)
22
Original Estimated Enrollment  ICMJE
 (submitted: February 18, 2010)
15
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01071473
Other Study ID Numbers  ICMJE CARHAB
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party St. Jude Children's Research Hospital
Study Sponsor  ICMJE St. Jude Children's Research Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daniel Green, MD St. Jude Children's Research Hospital
PRS Account St. Jude Children's Research Hospital
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP