Exercise Training in Patients With Hypertrophic Cardiomyopathy
NCT ID: NCT01518114
Last Updated: 2012-01-31
Study Results
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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UNKNOWN
NA
60 participants
INTERVENTIONAL
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Exercise Training
Exercise will be performed under continuous telemetry monitoring and medical supervision. Each session will include 5-10 worm-up, 30 min of aerobic activity on treadmill or bicycle ergometer followed by 10-15 min of stretch and relaxation exercise. Blood pressure will be obtained before the onset and at the end of each session. Participants will be requested to rest and observed 15-30 min before going home. The exercise intensity will be monitored and adjusted, per protocol, according to RPE using the Borg scale.
Exercise prescription will be based upon cardiopulmonary test done at baseline.
Exercise Training
Exercise will be performed under continuous telemetry monitoring and medical supervision. Each session will include 5-10 worm-up, 30 min of aerobic activity on treadmill or bicycle ergometer followed by 10-15 min of stretch and relaxation exercise. Blood pressure will be obtained before the onset and at the end of each session. Participants will be requested to rest and observed 15-30 min before going home. The exercise intensity will be monitored and adjusted, per protocol, according to RPE using the Borg scale.
Best Medical Care
Advanced HCM patients who are eligible to participate in the study but cannot do so for technical reasons will be invited to participate in the project as a control group.These subjects will continue their regular follow up in the Cardiomyopathy Clinic and their usual voluntary physical activity at home.
Exercise Training
Exercise will be performed under continuous telemetry monitoring and medical supervision. Each session will include 5-10 worm-up, 30 min of aerobic activity on treadmill or bicycle ergometer followed by 10-15 min of stretch and relaxation exercise. Blood pressure will be obtained before the onset and at the end of each session. Participants will be requested to rest and observed 15-30 min before going home. The exercise intensity will be monitored and adjusted, per protocol, according to RPE using the Borg scale.
Interventions
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Exercise Training
Exercise will be performed under continuous telemetry monitoring and medical supervision. Each session will include 5-10 worm-up, 30 min of aerobic activity on treadmill or bicycle ergometer followed by 10-15 min of stretch and relaxation exercise. Blood pressure will be obtained before the onset and at the end of each session. Participants will be requested to rest and observed 15-30 min before going home. The exercise intensity will be monitored and adjusted, per protocol, according to RPE using the Borg scale.
Eligibility Criteria
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Inclusion Criteria
* NYHA 3
* Maximal left ventricular wall thickness \> 20 mm
* Age \>18
Exclusion Criteria
* Patients state post resuscitation for malignant ventricular arrhythmia.
* History of effort induced syncope, complex ventricular arrhythmia or atrial fibrillation.
* An exercise-induced decrease in blood pressure
* Severe left ventricular outflow obstruction defined as resting outflow gradient \> 50 mmHg on maximal therapy
* Atrial fibrillation with a poorly controlled ventricular response
* Advanced hypokinetic stage of HCM defined as LVEF \< 40%
* Congestive heart failure of angina FC IV according to NYHA or CCS respectively.
18 Years
ALL
No
Sponsors
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Sheba Medical Center
OTHER_GOV
Responsible Party
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Dr. Michael Arad
MD
Locations
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Sheba Medical Center
Tel Hashomer , Ramat Gan, , Israel
Countries
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Central Contacts
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Facility Contacts
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Robert Klempfner, MD
Role: primary
Other Identifiers
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SHEBA-10-8081-MA-CTIL
Identifier Type: -
Identifier Source: org_study_id