Study of Exercise Training in Hypertrophic Cardiomyopathy
Condition: Cardiomyopathy, Hypertrophic
MeSH terms: Cardiomyopathies; Cardiomyopathy, Hypertrophic; Hypertrophy
Study type: Interventional

Summary: 
      The investigators propose a pilot randomized controlled trial to determine the safety and
      potential benefits of moderate intensity exercise in patients with hypertrophic
      cardiomyopathy. The investigators hypotheses are that exercise parameters derived from a
      baseline cardiopulmonary exercise test will target an appropriately safe level of exercise
      intensity that will not cause significant arrhythmias or exacerbate symptoms and that
      exercise training for 4 months will result in significant improvements in peak oxygen
      consumption (peak VO2) and quality of life, with neutral effects on the clinical
      characteristics.
    

Detailed description: 
      The goal of this randomized clinical pilot trial is to establish the safety profile and
      potential benefits of moderate intensity exercise in patients with hypertrophic
      cardiomyopathy (HCM). Participation in competitive athletics is associated with an increased
      risk of sudden cardiac death (SCD) in individuals with structural heart disease, including
      HCM. This has appropriately led to the establishment of national guidelines based on expert
      opinion that discourage participation in high intensity competitive sports, burst exertion
      (e.g., sprinting), or isometric exercise (e.g., heavy lifting). Non-competitive, low to
      moderate intensity exercise is allowable, although many physicians and HCM patients are still
      understandably apprehensive. Data on the safety of a recreational exercise program, and how
      to gauge appropriate intensity level, are desperately needed so that HCM patients can reap
      the well established health benefits of regular physical activity. Limited, but compelling
      animal data suggest that moderate intensity exercise is not only safe, but may also prevent
      or even reverse cardiac hypertrophy, fibrosis, myocellular disarray, and apoptosis associated
      with HCM. There are no published studies on exercise in patients with HCM, although large
      clinical trials in heart failure have shown exercise training to be safe, to improve peak VO2
      and quality of life, and to lower cardiovascular mortality. The pilot randomized control
      trial proposed here is the first to determine the safety of moderate intensity exercise
      training and explore its potential benefits in patients with HCM.
    

Intervention name(s): Exercise training
Intervention type(s): Behavioral
Intervention description(s): 4 months of exercise training that is custom-designed based on individual cardiopulmonary stress test data. Regimen starts at low intensity (60% of heart rate reserve) and frequency (20 minutes, 3 days per week) and increases with a goal of 70% of heart rate reserve and exercising 60 minutes 4-7 days per week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Hypertrophic Cardiomyopathy; Exercise; Oxygen consumption