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High Intensity Interval Exercise in Diastolic Heart Failure

Primary Purpose

Diastolic Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High intensity interval training
Moderate intensity exercise training
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diastolic Heart Failure

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arizona State University
  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High intensity interval training

Moderate intensity exercise training

Arm Description

High intensity interval training - 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)

Outcomes

Primary Outcome Measures

Left Ventricular Diastolic Dysfunction
Measured using left ventricular echocardiography. Diastolic dysfunction is graded as: normal, grade 1, grade 2, grade 3, grade 4. Increasing grade is indicative of worsening LV dysfunction and worse outcomes. Improvement in LV grade is associated with better long term outcomes.

Secondary Outcome Measures

VO2peak
Measured using a graded exercise test (modified Bruce protocol) with 12-lead EKG monitoring and ventilatory gas exchange analysis.

Full Information

First Posted
May 21, 2014
Last Updated
April 10, 2019
Sponsor
Arizona State University
Collaborators
Mayo Clinic, University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT02147613
Brief Title
High Intensity Interval Exercise in Diastolic Heart Failure
Official Title
High-intensity Aerobic Interval Training vs. Moderate-intensity Continuous Exercise Training in Heart Failure With Preserved Ejection Fraction
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arizona State University
Collaborators
Mayo Clinic, University of Alberta

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diastolic Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High intensity interval training
Arm Type
Experimental
Arm Description
High intensity interval training - 3 days per week at 85-90% peak heart rate (4x4 bouts) for 1 month (12 sessions of exercise)
Arm Title
Moderate intensity exercise training
Arm Type
Active Comparator
Arm Description
3 days/week, 30 mins at 70% Peak heart rate for 1 month (12 sessions of exercise)
Intervention Type
Other
Intervention Name(s)
High intensity interval training
Intervention Description
3 days per week at 85-90% peak heart rate (4x4 bouts) for 1 month (12 sessions of exercise)
Intervention Type
Other
Intervention Name(s)
Moderate intensity exercise training
Intervention Description
3 days/week, 30 mins at 70% Peak heart rate for 1 month (12 sessions of exercise)
Primary Outcome Measure Information:
Title
Left Ventricular Diastolic Dysfunction
Description
Measured using left ventricular echocardiography. Diastolic dysfunction is graded as: normal, grade 1, grade 2, grade 3, grade 4. Increasing grade is indicative of worsening LV dysfunction and worse outcomes. Improvement in LV grade is associated with better long term outcomes.
Time Frame
Before and after the 1 month exercise intervention
Secondary Outcome Measure Information:
Title
VO2peak
Description
Measured using a graded exercise test (modified Bruce protocol) with 12-lead EKG monitoring and ventilatory gas exchange analysis.
Time Frame
Test carried out before and after the 1 month long exercise intervention.
Other Pre-specified Outcome Measures:
Title
Brachial Artery Flow-mediated Dilation
Description
Reactive hyperemia mediated brachial artery dilation will be measured after 5 minutes of ischemia with forearm cuff occlusion. Artery will be continuously monitored using B-mode ultrasound.
Time Frame
Before and after 1-month exercise intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Arizona State University
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25190739
Citation
Angadi SS, Mookadam F, Lee CD, Tucker WJ, Haykowsky MJ, Gaesser GA. High-intensity interval training vs. moderate-intensity continuous exercise training in heart failure with preserved ejection fraction: a pilot study. J Appl Physiol (1985). 2015 Sep 15;119(6):753-8. doi: 10.1152/japplphysiol.00518.2014. Epub 2014 Sep 4.
Results Reference
derived

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High Intensity Interval Exercise in Diastolic Heart Failure

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