Exercise Training in Patients With Hypertrophic Cardiomyopathy

January 26, 2012 updated by: Dr. Michael Arad, Sheba Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Hashomer , Ramat Gan, Israel
        • Recruiting
        • Sheba Medical Center
        • Contact:
        • Principal Investigator:
          • Arad Michael, MD
        • Sub-Investigator:
          • Tamir Kamerman, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional capacity improvement as determined by the degree of percent change in VO2 MAX following structured exercise rehabilitation
Time Frame: 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).
6 months
Safety of exercise training in patients with symptomatic hypertrophic cardiomyopathy
Time Frame: 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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Endpoints:
Time Frame: 12 months
  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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Anticipated)

January 1, 2013

Study Registration Dates

First Submitted

January 10, 2012

First Submitted That Met QC Criteria

January 24, 2012

First Posted (Estimate)

January 25, 2012

Study Record Updates

Last Update Posted (Estimate)

January 31, 2012

Last Update Submitted That Met QC Criteria

January 26, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-10-8081-MA-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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