Resistance and Aerobic Exercise for Subclinical Anthracycline Cardiomyopathy

Cardiomyopathy Clinical Trial

Official title:

Resistance and Aerobic Exercise for Subclinical Anthracycline Cardiomyopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01071473
• Other study ID #: CARHAB
• Status: Completed
• Phase: N/A
• First received: February 17, 2010
• Last updated: February 6, 2014
• Start date: February 2010
• Est. completion date: October 2012

Study information

• Verified date: February 2014
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy

Intervention

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.

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		12 Weeks	Yes

External Links

•   St. Jude Children's Research Hospital