Resistance and Aerobic Exercise for Subclinical Anthracycline Cardiomyopathy

NCT01071473 | Completed

• 1 other identifier: CARHAB
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiomyopathy

Keywords

Childhood cancer; Anthracyclines; Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Exercise Group

OTHER

Survivors of childhood cancer treated with anthracyclines and known to have cardiomyopathy will participate in a 12 week exercise intervention.

Other: 12 Week Exercise Intervention

Interventions

12 Week Exercise Intervention 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.

Exercise Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital

MeSH Terms

Conditions

Cardiomyopathies; Neoplasms

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Daniel Green, MD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2010
• First Posted: February 19, 2010
• Study Start: February 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: February 10, 2014

Record last verified: 2014-02

Locations

US (1)