Diastolic Heart FailureNCT02147613
High Intensity Interval Exercise in Diastolic Heart Failure
A study testing High intensity interval training and Moderate intensity exercise training in people with Diastolic Heart Failure, run by Arizona State University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Diastolic Heart Failure
- What is being tested?
- High intensity interval training and Moderate intensity exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2010to Apr 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HFpEF diagnosis with New York Heart Association heart failure Class II-III symptoms
Who cannot join
- 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
Show all 10Show fewer
- Symptomatic severe aortic stenosis
- Acute pulmonary embolus
- Acute myocarditis
- Medication non-compliance
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Arizona State University
Phoenix, Arizona, 85004
Mayo Clinic
Scottsdale, Arizona, 85259
About this study
Official title: High-intensity Aerobic Interval Training vs. Moderate-intensity Continuous Exercise Training in Heart Failure With Preserved Ejection Fraction
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.
Read the 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.
- Conditions
- Diastolic Heart Failure
- Being tested
- High intensity interval training, Moderate intensity exercise training
- Medical subject headings
- Heart Failure, Diastolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity interval trainingOther
3 days per week at 85-90% peak heart rate (4x4 bouts) for 1 month (12 sessions of exercise)
Moderate intensity exercise trainingOther
3 days/week, 30 mins at 70% Peak heart rate for 1 month (12 sessions of exercise)
| Study group | Role | What they receive |
|---|---|---|
| High intensity interval training | Experimental | High intensity interval training - 3 days per week at 85-90% peak heart rate (4x4 bouts) for 1 month (12 sessions of exercise) Receives: Other: High intensity interval training |
| Moderate intensity exercise training | Active comparator | 3 days/week, 30 mins at 70% Peak heart rate for 1 month (12 sessions of exercise) Receives: Other: Moderate intensity exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before and after the 1 month exercise intervention
Secondary outcomes (1)
VO2peak
Measured using a graded exercise test (modified Bruce protocol) with 12-lead EKG monitoring and ventilatory gas exchange analysis.
Measured: Test carried out before and after the 1 month long exercise intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startNov 2010
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diastolic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic, University of Alberta
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02147613
- Sponsor's protocol ID
- Mayo-ArizonaSU Seed 93016001
- Status last verified
- Jan 2019
- First submitted
- 21 May 2014
- Last updated
- 12 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 25190739
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-intensity Aerobic Interval Training vs. Moderate-intensity Continuous Exercise Training in Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT02147613
- Acronym / sponsor ID
- Mayo-ArizonaSU Seed 93016001
- Conditions
- Diastolic Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- Mayo Clinic, University of Alberta
- Study start
- Nov 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 28 May 2014 (estimated)
- Results
- Posted 12 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High intensity interval training | Experimental | Other: High intensity interval trainingHigh intensity interval training - 3 days per week at 85-90% peak heart rate (4x4 bouts) for 1 month (12 sessions of exercise) |
| Moderate intensity exercise training | Active comparator | Other: Moderate intensity exercise training3 days/week, 30 mins at 70% Peak heart rate for 1 month (12 sessions of exercise) |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- HFpEF diagnosis with New York Heart Association heart failure Class II-III symptoms
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High intensity interval training3 days per week at 85-90% peak heart rate (4x4 bouts) for 1 month (12 sessions of exercise) | Other | High intensity interval training |
| Moderate intensity exercise training3 days/week, 30 mins at 70% Peak heart rate for 1 month (12 sessions of exercise) | Other | Moderate intensity exercise training |
Primary outcome
Left Ventricular Diastolic Dysfunction
Time frame: Before and after the 1 month exercise intervention
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.
1 secondary outcome
VO2peak
Time frame: Test carried out before and after the 1 month long exercise intervention.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25190739Angadi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity interval training and Moderate intensity exercise training in people with Diastolic Heart Failure, run by Arizona State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left Ventricular Diastolic Dysfunction (time frame: Before and after the 1 month exercise intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02147613, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2019.