N/A
N=19
High Intensity Interval Exercise in Diastolic Heart Failure
Diastolic Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT02147613 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Left Ventricular Diastolic Dysfunction — 2.1; 2; 1.3; 2.2 DD grade
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- High intensity interval training (Other); Moderate intensity exercise training (Other)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Arizona State University
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Left Ventricular Diastolic Dysfunction |
2.1; 2; 1.3; 2.2 | — |
| SECONDARY VO2peak |
19.2; 16.9; 21; 16.8 | — |
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.
Eligibility Criteria
Inclusion Criteria
- HFpEF diagnosis with New York Heart Association heart failure Class II-III symptoms
Exclusion Criteria
- Unstable angina
- Myocardial infarction in the past 4 weeks
- Uncompensated heart failure
- New York Heart Association class IV symptoms
- Complex ventricular arrhythmias (at rest or during the maximal exercise test)
- Medical or orthopedic conditions that precluded treadmill walking
- Symptomatic severe aortic stenosis
- Acute pulmonary embolus
- Acute myocarditis
- Medication non-compliance
Data sourced from ClinicalTrials.gov (NCT02147613). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.