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

NCT02916225 | Completed

• 1 other identifier: 140362
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Diastolic Heart Failure

Outcome Measures

Primary Outcomes (1)

• Maximal Oxygen Consumption

  12 weeks after beginning of training

Secondary Outcomes (4)

• 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

Study Arms (2)

High intensity interval training

ACTIVE COMPARATOR

exercise protocol for high intensity/aerobic interval training as described by ESC statement (Mezzani et al.)

Behavioral: High Intensity Interval Training

Moderate Continuous Training

PLACEBO COMPARATOR

exercise protocol for continuous aerobic training as described by ESC statement (Mezzani et al.)

Behavioral: Moderate Continuous Training

Interventions

High Intensity Interval Training BEHAVIORAL

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.

High intensity interval training

Moderate Continuous Training BEHAVIORAL

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.

Moderate Continuous Training

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

Related Publications (5)

• 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 BACKGROUND

• 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.

  PMID: 17548726 BACKGROUND

• 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.

  PMID: 17428822 BACKGROUND

• 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.

  PMID: 21996391 BACKGROUND

• 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.

  PMID: 31964186 DERIVED

MeSH Terms

Conditions

Heart Failure; Heart Failure, Diastolic

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ricardo Stein, ScD

  Hospital de Clínicas de Porto Alegre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 25, 2016
• First Posted: September 27, 2016
• Study Start: June 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2018
• Last Updated: April 3, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)