An interventional study of Exercise Training in Hypertrophic Cardiomyopathy, sponsored by Sheba Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-01-31.
Sponsored by Sheba Medical Center · Not applicable, Interventional, and Treatment
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.
1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.
This study's planned enrollment of 60 is above the median of 51 across 609 interventional studies indexed under Cardiomyopathies.
Browse Cardiomyopathies studies →Sheba Medical Center is the lead sponsor of 660 studies on the registry; 63 are open to participants now.
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Exclusion Criteria:
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
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.
Functional capacity improvement as determined by the degree of percent change in VO2 MAX following structured exercise rehabilitation
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).
Time frame: 6 months
Safety of exercise training in patients with symptomatic hypertrophic cardiomyopathy
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
Time frame: 12 months
Secondary Endpoints:
1. The effect on quality of life 2. The change in maximal wall thickness, LVEF, resting and exercise-induced left ventricular outflow gradient and pulmonary artery pressure (stress echo). 3. Resting BNP and troponin I levels
Time frame: 12 months
This study is status unknown, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
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