CardiomyopathyNCT01071473
Resistance and Aerobic Exercise for Subclinical Anthracycline Cardiomyopathy
A study testing 12 Week Exercise Intervention in people with Cardiomyopathy, run by St. Jude Children's Research Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiomyopathy
- What is being tested?
- 12 Week Exercise Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
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.
Read the 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.
- Conditions
- Cardiomyopathy
- Being tested
- 12 Week Exercise Intervention
- Keywords
- Childhood cancer, Anthracyclines, Cardiomyopathy
- Medical subject headings
- Cardiomyopathies, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12 Week Exercise InterventionOther
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 group | Role | What they receive |
|---|---|---|
| Exercise Group | Other | Survivors of childhood cancer treated with anthracyclines and known to have cardiomyopathy will participate in a 12 week exercise intervention. Receives: Other: 12 Week Exercise Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiomyopathyStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Green, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01071473
- Sponsor's protocol ID
- CARHAB
- Status last verified
- Feb 2014
- First submitted
- 17 Feb 2010
- Last updated
- 10 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistance and Aerobic Exercise for Subclinical Anthracycline Cardiomyopathy
- ClinicalTrials.gov ID
- NCT01071473
- Acronym / sponsor ID
- CARHAB
- Conditions
- Cardiomyopathy
- Keywords
- Childhood cancer, Anthracyclines, Cardiomyopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 19 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Other | Other: 12 Week Exercise InterventionSurvivors of childhood cancer treated with anthracyclines and known to have cardiomyopathy will participate in a 12 week exercise intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- Ejection fraction ≤ 40%
- Pregnant females (Positive Urine pregnancy Test).
- History of congenital heart disease
- History of myocardial infarction
- History of acute coronary syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 12 Week Exercise InterventionTrial 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. | Other | Exercise Group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2014.
- St. Jude Children's Research HospitalLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Green, MD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12 Week Exercise Intervention in people with Cardiomyopathy, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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. (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2014.