Resistance and Aerobic Exercise for Subclinical Anthracycline Cardiomyopathy

NCT ID: NCT01071473

Last Updated: 2014-02-10

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-10-31

Brief Summary

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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

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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.

Conditions

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Cardiomyopathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

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.

Group Type OTHER

12 Week Exercise Intervention

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Jude Children's Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Related Links

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http://www.stjude.org

St. Jude Children's Research Hospital

Other Identifiers

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CARHAB

Identifier Type: -

Identifier Source: org_study_id

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