Exercise Training in Patients With Hypertrophic Cardiomyopathy

Sheba Medical Center

Status: Unknown

Conditions: Hypertrophic Cardiomyopathy

Treatments: Behavioral: Exercise Training

Study type: Interventional

Funder types: Other

Identifiers

NCT01518114

SHEBA-10-8081-MA-CTIL

Details and patient eligibility

About

Exercise training (ET) is highly beneficial in heart failure patients and has been suggested to confer significant symptomatic and functional improvements in patients with diastolic dysfunction. Accordingly, the aim of this study was to examine the safety, feasibility of a structured ET program in symptomatic HCM patients.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hypertrophic Cardiomyopathy
• NYHA 3
• Maximal left ventricular wall thickness > 20 mm
• Age >18

Exclusion criteria

• Severe non-cardiac limitations of functional capacity such as neurological illness, lung disease, peripheral vascular or orthopedic problem, etc.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Exercise Training

Experimental group

Description:

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.

Treatment:

Behavioral: Exercise Training

Best Medical Care

Active Comparator group

Description:

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.

Treatment:

Behavioral: Exercise Training