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High Intensity Interval Exercise in Diastolic Heart Failure

High-intensity Aerobic Interval Training vs. Moderate-intensity Continuous Exercise Training in Heart Failure With Preserved Ejection Fraction

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02147613
Enrollment
19
Registered
2014-05-28
Start date
2010-11-30
Completion date
2012-04-30
Last updated
2019-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diastolic Heart Failure

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.

Interventions

OTHERHigh 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)

Sponsors

Mayo Clinic
CollaboratorOTHER
University of Alberta
CollaboratorOTHER
Arizona State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Left Ventricular Diastolic DysfunctionBefore and after the 1 month exercise interventionMeasured 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

MeasureTime frameDescription
VO2peakTest carried out before and after the 1 month long exercise intervention.Measured using a graded exercise test (modified Bruce protocol) with 12-lead EKG monitoring and ventilatory gas exchange analysis.

Other

MeasureTime frameDescription
Brachial Artery Flow-mediated DilationBefore and after 1-month exercise interventionReactive 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
High Intensity Interval Training
High intensity interval training - 3 days per week at 85-90% peak heart rate (4x4 bouts) for 1 month (12 sessions of exercise) High intensity interval training: 3 days per week at 85-90% peak heart rate (4x4 bouts) for 1 month (12 sessions of exercise)
10
Moderate Intensity Exercise Training
3 days/week, 30 mins at 70% Peak heart rate for 1 month (12 sessions of exercise) Moderate intensity exercise training: 3 days/week, 30 mins at 70% Peak heart rate for 1 month (12 sessions of exercise)
9
Total19

Baseline characteristics

CharacteristicModerate Intensity Exercise TrainingTotalHigh Intensity Interval Training
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
5 Participants12 Participants7 Participants
Age, Categorical
Between 18 and 65 years
1 Participants3 Participants2 Participants
Age, Continuous
Mean age of completers
71.5 years
STANDARD_DEVIATION 11.7
69.9 years
STANDARD_DEVIATION 8.3
69 years
STANDARD_DEVIATION 6.1
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United States
9 participants19 participants10 participants
Sex: Female, Male
Female
2 Participants3 Participants1 Participants
Sex: Female, Male
Male
4 Participants12 Participants8 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 100 / 9
other
Total, other adverse events
0 / 100 / 9
serious
Total, serious adverse events
0 / 100 / 9

Outcome results

Primary

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.

Time frame: Before and after the 1 month exercise intervention

ArmMeasureGroupValue (MEAN)Dispersion
High Intensity Interval TrainingLeft Ventricular Diastolic DysfunctionPre2.1 DD gradeStandard Deviation 0.3
High Intensity Interval TrainingLeft Ventricular Diastolic DysfunctionPost1.3 DD gradeStandard Deviation 0.7
Moderate Intensity Exercise TrainingLeft Ventricular Diastolic DysfunctionPre2 DD gradeStandard Deviation 0.6
Moderate Intensity Exercise TrainingLeft Ventricular Diastolic DysfunctionPost2.2 DD gradeStandard Deviation 0.8
Secondary

VO2peak

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.

ArmMeasureGroupValue (MEAN)Dispersion
High Intensity Interval TrainingVO2peakPre19.2 ml/kg/minStandard Deviation 5.2
High Intensity Interval TrainingVO2peakPost21 ml/kg/minStandard Deviation 5.2
Moderate Intensity Exercise TrainingVO2peakPre16.9 ml/kg/minStandard Deviation 3
Moderate Intensity Exercise TrainingVO2peakPost16.8 ml/kg/minStandard Deviation 4
Other Pre-specified

Brachial Artery Flow-mediated Dilation

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

ArmMeasureGroupValue (MEAN)Dispersion
High Intensity Interval TrainingBrachial Artery Flow-mediated DilationPre6.9 percentage of FMDStandard Deviation 3.7
High Intensity Interval TrainingBrachial Artery Flow-mediated DilationPost7 percentage of FMDStandard Deviation 4.2
Moderate Intensity Exercise TrainingBrachial Artery Flow-mediated DilationPost3.4 percentage of FMDStandard Deviation 3.6
Moderate Intensity Exercise TrainingBrachial Artery Flow-mediated DilationPre8.1 percentage of FMDStandard Deviation 4.1

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026