Exercise Training in Patients With Hypertrophic Cardiomyopathy

Sponsor

Sheba Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT01518114

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertrophic Cardiomyopathy	Behavioral: Exercise Training	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Study Start Date :

Dec 1, 2011

Anticipated Primary Completion Date :

Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: 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.
Active Comparator: 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.	Behavioral: 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.

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: Exercise Training

Active Comparator: 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.

Behavioral: Exercise Training

Outcome Measures

Primary Outcome Measures

Functional capacity improvement as determined by the degree of percent change in VO2 MAX following structured exercise rehabilitation [6 months]
End point to be assessed by cardiopulmonary testing are pre- and post exercise training improvement as expressed by the changes in : VO2 MAX, exercise duration, duration to ventilatory threshold(VT).
Safety of exercise training in patients with symptomatic hypertrophic cardiomyopathy [12 months]
Safety endpoonts: 1) Clinicaly significant arrhythmia during exercise training 2)MACE during follow-up period (ACS, Stroke or Death) 3)Exercise Related Injury 4) Episodes of syncope

Secondary Outcome Measures

Secondary Endpoints: [12 months]
The effect on quality of life The change in maximal wall thickness, LVEF, resting and exercise-induced left ventricular outflow gradient and pulmonary artery pressure (stress echo). Resting BNP and troponin I levels

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.