High Intensity Interval Training Versus Moderate Continuous Training in Heart Failure With Preserved Ejection Fraction Patients: a Randomized Study.
High Intensity Interval Training Versus Moderate Continuous Training in Heart Failure With Preserved Ejection Fraction
Sponsors
Source
Hospital de Clinicas de Porto Alegre
Oversight Info
Has Dmc
No
Brief 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.
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.
Overall Status
Completed
Start Date
2014-06-01
Completion Date
2018-03-01
Primary Completion Date
2017-03-01
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Maximal Oxygen Consumption |
12 weeks after beginning of training |
Secondary Outcome
Measure |
Time Frame |
|
Diastolic Function |
12 weeks after beginning of training |
|
Pulmonary function tests |
12 weeks after beginning of training |
|
Respiratory muscle strength |
12 weeks after beginning of training |
|
Quality of life |
12 weeks after beginning of training |
Enrollment
19
Conditions
Intervention
Intervention Type
Behavioral
Intervention Name
Description
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.
Arm Group Label
High intensity interval training
Intervention Type
Behavioral
Intervention Name
Description
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.
Arm Group Label
Moderate Continuous Training
Eligibility
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Gender
All
Minimum Age
35 Years
Maximum Age
75 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Ricardo Stein, ScD |
Study Director |
Hospital de Clínicas de Porto Alegre |
Location
Facility |
|
Hospital de Clínicas de Porto Alegre Porto Alegre RS Brazil |
Location Countries
Country
Brazil
Verification Date
2018-03-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
Hospital de Clinicas de Porto Alegre
Investigator Full Name
Ricardo Stein
Investigator Title
Assistant Professor
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Arm Group
Arm Group Label
High intensity interval training
Arm Group Type
Active Comparator
Description
exercise protocol for high intensity/aerobic interval training as described by ESC statement (Mezzani et al.)
Arm Group Label
Moderate Continuous Training
Arm Group Type
Placebo Comparator
Description
exercise protocol for continuous aerobic training as described by ESC statement (Mezzani et al.)
Firstreceived Results Date
N/A
Reference
Citation
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.
PMID
23104970
Citation
Wisløff U, Støylen A, Loennechen JP, Bruvold M, Rognmo Ø, Haram PM, Tjønna AE, Helgerud J, Slørdahl SA, Lee SJ, Videm V, Bye A, Smith GL, Najjar SM, Ellingsen Ø, 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. Epub 2007 Jun 4.
PMID
17548726
Citation
Paulus WJ, Tschöpe C, Sanderson JE, Rusconi C, Flachskampf FA, Rademakers FE, Marino P, Smiseth OA, De Keulenaer G, Leite-Moreira AF, Borbély 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. Epub 2007 Apr 11.
PMID
17428822
Citation
Edelmann F, Gelbrich G, Düngen HD, Fröhling S, Wachter R, Stahrenberg R, Binder L, Töpper A, Lashki DJ, Schwarz S, Herrmann-Lingen C, Löffler 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.
PMID
21996391
Patient Data
Sharing Ipd
No
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)
Study First Submitted
September 25, 2016
Study First Submitted Qc
September 25, 2016
Study First Posted
September 27, 2016
Last Update Submitted
March 31, 2018
Last Update Submitted Qc
March 31, 2018
Last Update Posted
April 3, 2018
ClinicalTrials.gov processed this data on August 27, 2018
Conditions
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conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.