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Heart FailureNCT02916225

High Intensity Interval Training Versus Moderate Continuous Training in Heart Failure With Preserved Ejection Fraction

A study testing High Intensity Interval Training and Moderate Continuous Training in people with Heart Failure and Diastolic Heart Failure, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine whether high intensity interval training (HIIT) is superior to moderate continuous training in increasing cardiopulmonary capacity in heart failure with preserved ejection fraction patients. Read more about this study

Who is it for?
Ages 35 to 75 years
Conditions the study is for
Heart Failure, Diastolic Heart Failure
What is being tested?
High Intensity Interval Training and Moderate Continuous Training
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
19 participants
Where
1 siteBrazil
Study dates
Jun 2014to Mar 2018
Phase
Interventional
Are there results?
None posted in the registry

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 35 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with heart failure with preserved ejection fraction (HFPEF) of any etiology that have functional class of the New York Heart Association (NYHA) between I and III, left ventricular ejection fraction > 50% and who meet clinical and echocardiography criteria for HFPEF according to the consensus statement on the diagnosis of heart failure with normal left ventricular ejection fraction by the Heart Failure and Echocardiography Associations of the European Society of Cardiology (Paulus et al.). Patients should be clinical stable for the last 3 months and under optimized pharmacologic treatment, being capable of walking without limitations.

Who cannot join

  • Patients with exercise-induced unstable ventricular arrhythmias, unstable angina, moderate to severe valvular heart disease, severe pulmonary disease, severe anemia, cognitive limitations to understand study protocol, use of pacemaker, autonomic neuropathy, cardiovascular event for less than 3 months, congenital heart disease, terminal illness with less than 1 year of life expectancy, peripheral arterial disease with intermittent claudication or osteoarticular conditions limiting exercise will be excluded.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul

Other trials in Brazil

About this study

Official title: High Intensity Interval Training Versus Moderate Continuous Training in Heart Failure With Preserved Ejection Fraction Patients: a Randomized Study.

The purpose of this study is to determine whether high intensity interval training (HIIT) is superior to moderate continuous training in increasing cardiopulmonary capacity in heart failure with preserved ejection fraction patients.

Read the detailed description

High intensity interval training (HIIT) has been proved to increase oxygen consumption, having superior cardiovascular effect when compared to moderate continuous training (MCT) in post-infarction patients (Wisloff et al.) Aerobic training also had shown positive effect on oxygen consumption and diastolic function in subjects with HFPEF when compared to usual care (Edelmann et al).

However, the comparison of HIIT and MCT on improving functional capacity and diastolic function in HFPEF patients has not yet been study.

Being tested
High Intensity Interval Training, Moderate Continuous Training
Medical subject headings
Heart Failure, 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 TrainingBehavioural

    The HIIT group will warm up for 10 minutes at 60% to 70% of peak heart rate(50% to 60% of V̇O2peak) before walking four 4-minute intervals at 85% to 95% of peak heart rate. Each interval will be separated by 3-minute active pauses, walking at 60% to 70% of peak heart rate. The training session will be terminated by a 3-minute cool-down at 60% to 70% of peak heart rate. Total exercise time will be 38 minutes for the HIIT group. Patients will perform 3 training sessions per week for 12 consecutive weeks.

  • Moderate Continuous TrainingBehavioural

    The moderate continuous training (MCT) group will undergo treadmill walking continuously at 60% to 70% of peak heart rate for 47 minutes each session to make sure the training protocols will be isocaloric. Patients will perform 3 training sessions per week for 12 consecutive weeks.

Study groups in NCT02916225
Study groupRoleWhat they receive
High intensity interval trainingActive comparatorexercise protocol for high intensity/aerobic interval training as described by ESC statement (Mezzani et al.)
Receives: Behavioral: High Intensity Interval Training
Moderate Continuous TrainingPlacebo comparatorexercise protocol for continuous aerobic training as described by ESC statement (Mezzani et al.)
Receives: Behavioral: Moderate Continuous Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximal Oxygen Consumption

    Measured: 12 weeks after beginning of training

Secondary outcomes (4)

  1. Diastolic Function

    assessed by echocardiography

    Measured: 12 weeks after beginning of training

  2. Pulmonary function tests

    assessed by spirometry

    Measured: 12 weeks after beginning of training

  3. Respiratory muscle strength

    assessed by manovacuometry

    Measured: 12 weeks after beginning of training

  4. Quality of life

    Minnesota Living with Heart Failure Questionnaire

    Measured: 12 weeks after beginning of training

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2016 (estimated)
  2. Study startJun 2014
  3. Primary completionMar 2017
  4. Study completionMar 2018

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02916225
Sponsor's protocol ID
140362
Status last verified
Mar 2018
First submitted
25 Sep 2016
Last updated
3 Apr 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Mezzani A, Hamm LF, Jones AM, McBride PE, Moholdt T, Stone JA, Urhausen A, Williams MA; European Association for Cardiovascular Prevention and Rehabilitation; American Association of Cardiovascular and Pulmonary Rehabilitation; Canadian Association of Cardiac Rehabilitation. Aerobic exercise intensity assessment and prescription in cardiac rehabilitation: a joint position statement of the European Association for Cardiovascular Prevention and Rehabilitation, the American Association of Cardiovascular and Pulmonary Rehabilitation and the Canadian Association of Cardiac Rehabilitation. Eur J Prev Cardiol. 2013 Jun;20(3):442-67. doi: 10.1177/2047487312460484. Epub 2012 Oct 26.

    PubMed 23104970

  • Wisloff U, Stoylen A, Loennechen JP, Bruvold M, Rognmo O, Haram PM, Tjonna AE, Helgerud J, Slordahl SA, Lee SJ, Videm V, Bye A, Smith GL, Najjar SM, Ellingsen O, Skjaerpe T. Superior cardiovascular effect of aerobic interval training versus moderate continuous training in heart failure patients: a randomized study. Circulation. 2007 Jun 19;115(24):3086-94. doi: 10.1161/CIRCULATIONAHA.106.675041. Epub 2007 Jun 4.

    PubMed 17548726

  • Paulus WJ, Tschope C, Sanderson JE, Rusconi C, Flachskampf FA, Rademakers FE, Marino P, Smiseth OA, De Keulenaer G, Leite-Moreira AF, Borbely A, Edes I, Handoko ML, Heymans S, Pezzali N, Pieske B, Dickstein K, Fraser AG, Brutsaert DL. How to diagnose diastolic heart failure: a consensus statement on the diagnosis of heart failure with normal left ventricular ejection fraction by the Heart Failure and Echocardiography Associations of the European Society of Cardiology. Eur Heart J. 2007 Oct;28(20):2539-50. doi: 10.1093/eurheartj/ehm037. Epub 2007 Apr 11.

    PubMed 17428822

  • Edelmann F, Gelbrich G, Dungen HD, Frohling S, Wachter R, Stahrenberg R, Binder L, Topper A, Lashki DJ, Schwarz S, Herrmann-Lingen C, Loffler M, Hasenfuss G, Halle M, Pieske B. Exercise training improves exercise capacity and diastolic function in patients with heart failure with preserved ejection fraction: results of the Ex-DHF (Exercise training in Diastolic Heart Failure) pilot study. J Am Coll Cardiol. 2011 Oct 18;58(17):1780-91. doi: 10.1016/j.jacc.2011.06.054.

    PubMed 21996391

  • Donelli da Silveira A, Beust de Lima J, da Silva Piardi D, Dos Santos Macedo D, Zanini M, Nery R, Laukkanen JA, Stein R. High-intensity interval training is effective and superior to moderate continuous training in patients with heart failure with preserved ejection fraction: A randomized clinical trial. Eur J Prev Cardiol. 2020 Nov;27(16):1733-1743. doi: 10.1177/2047487319901206. Epub 2020 Jan 21.

    PubMed 31964186

Questions about this trial

What is this clinical trial studying?

A study testing High Intensity Interval Training and Moderate Continuous Training in people with Heart Failure and Diastolic Heart Failure, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.

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 1 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 3 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Maximal Oxygen Consumption (time frame: 12 weeks after beginning of training). 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 NCT02916225, which also lists 5 linked publications.

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 3 Apr 2018.

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