High Intensity Interval Exercise in Diastolic Heart Failure
Condition: Diastolic Heart Failure
MeSH terms: Heart Failure; Heart Failure, Diastolic
Study type: Interventional

Summary: 
      Heart failure is a major health concern and is the leading cause of hospitalization among
      elderly Americans. Currently 5.7 million Americans are estimated to have heart failure and
      the estimated direct and indirect costs of treating heart failure are approximately $37.2
      billion. Approximately 40% of those diagnosed with heart failure will have heart failure with
      preserved ejection fraction (HFPEF). These individuals have significant restrictions in their
      ability to carry out activities of daily living. Exercise training has been established as
      adjuvant therapy in heart failure. Although exercise training guidelines for treatment of
      heart failure with reduced ejection fraction (HFREF) are well established, no consensus
      exercise guidelines exist for management of HFPEF. Aerobic and cardiovascular adaptations are
      generally greater after high-intensity exercise training; interval-type exercise facilitates
      this type of training because it allows for rest periods that make it possible for patients
      with heart failure to perform short (e.g., 1-4 minutes) work periods at intensities that are
      higher than would be possible during continuous exercise. High-intensity aerobic interval
      training presents a unique, yet untested, therapeutic modality for the exercise training of
      patients with heart failure with preserved ejection fraction. Pilot testing is warranted,
      results of which may have important implications for reducing cardiovascular risk, increasing
      short- and long-term quality of life and survival, and reducing healthcare costs in this
      patient population. The investigators primary specific aim is to determine the efficacy of a
      novel, high-intensity aerobic interval exercise training program for improving VO2peak (peak
      oxygen uptake), endothelial function, and arterial stiffness in patients with HFPEF. The
      investigators secondary aim is to determine whether the vascular changes are correlated with
      the changes in VO2peak.
    

Detailed description: 
      Heart failure is a major health concern and is the leading cause of hospitalization among
      elderly Americans. Currently 5.7 million Americans are estimated to have heart failure and
      the estimated direct and indirect costs of treating heart failure are approximately $37.2
      billion. Approximately 40% of those diagnosed with heart failure will have heart failure with
      preserved ejection fraction (HFPEF).2 These individuals have significant restrictions in
      their ability to carry out activities of daily living.

      Exercise training has been established as adjuvant therapy in heart failure.4 Although
      exercise training guidelines for treatment of heart failure with reduced ejection fraction
      (HFREF) are well established, no consensus exercise guidelines exist for management of HFPEF.
      Exercise training increases VO2peak, thus improving prognosis for patients with heart
      failure. Indeed, VO2peak has been reported to be the single best predictor of mortality in
      those with cardiac disease.6 Exercise training also improves endothelial function and reduces
      arterial stiffness, as well as enhancing quality of life.7,8 Because HFPEF is associated with
      a both diastolic dysfunction and a loss of compensatory systemic vasodilator reserves,
      arterial stiffness and endothelial function are especially important in this population.

      Aerobic and cardiovascular adaptations are generally greater after high-intensity exercise
      training; interval-type exercise facilitates this type of training because it allows for rest
      periods that make it possible for patients with heart failure to perform short (e.g., 1-4
      minutes) work periods at intensities that are higher than would be possible during continuous
      exercise. For example, Wisloff et al. demonstrated the superiority of high-intensity aerobic
      interval training, as compared to continuous, moderate-intensity exercise training, in
      patients with stable postinfarction heart failure (with reduced ejection fraction). Not only
      was VO2peak and FMD improved more, patients tolerated the high-intensity program without
      reported incident. Furthermore, they found it "motivating to have a varied procedure to
      follow," whereas patients found the continuous exercise group training sessions to be "quite
      boring." High-intensity aerobic interval training presents a unique, yet untested,
      therapeutic modality for the exercise training of patients with heart failure with preserved
      ejection fraction.

      Pilot testing is warranted, results of which may have important implications for reducing
      cardiovascular risk, increasing short- and long-term quality of life and survival, and
      reducing healthcare costs in this patient population.Patients undergoing exercise training
      live on average 2.16 years longer at the extremely low cost-effectiveness ratio of $1494 per
      life year saved.Since the majority of this patient population belongs to the Medicare age
      group, this intervention has significant potential to reduce healthcare costs.

      Hypotheses and Specific Aims Our primary specific aim is to determine the efficacy of a
      novel, high-intensity aerobic interval exercise training program for improving VO2peak,
      endothelial function, and arterial stiffness in patients with HFPEF. Our secondary aim is to
      determine whether the vascular changes are correlated with the changes in VO2peak.

      We hypothesize that improvements in VO2peak, endothelial function, and arterial stiffness
      will be greater after the high-intensity aerobic interval training program and that vascular
      adaptations will be correlated with changes in VO2peak.
    

Intervention name(s): High intensity interval training; Moderate intensity exercise training
Intervention type(s): Other; Other
Intervention description(s): 3 days per week at 85-90% peak heart rate (4x4 bouts) for 1 month (12 sessions of exercise); 3 days/week, 30 mins at 70% Peak heart rate for 1 month (12 sessions of exercise)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment