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

Not Applicable

Completed

• Conditions: Diastolic Heart Failure; Heart Failure
• Interventions: Behavioral: High Intensity Interval Training; Behavioral: Moderate Continuous Training

• Registration Number: NCT02916225
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2016-09-25
• Study First Submitted QC: 2016-09-25
• Study First Posted: 2016-09-27
• Primary Completion: 2017-03
• Status Verified: 2018-03
• Study Completion: 2018-03
• Last Update Submitted: 2018-03-31
• Last Update Posted: 2018-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High intensity interval training	High Intensity Interval Training	exercise protocol for high intensity/aerobic interval training as described by ESC statement (Mezzani et al.)
Moderate Continuous Training	Moderate Continuous Training	exercise protocol for continuous aerobic training as described by ESC statement (Mezzani et al.)

Primary Outcome Measures

Name	Time	Method
Maximal Oxygen Consumption	12 weeks after beginning of training

Secondary Outcome Measures

Name	Time	Method
Diastolic Function	12 weeks after beginning of training	assessed by echocardiography
Pulmonary function tests	12 weeks after beginning of training	assessed by spirometry
Respiratory muscle strength	12 weeks after beginning of training	assessed by manovacuometry
Quality of life	12 weeks after beginning of training	Minnesota Living with Heart Failure Questionnaire

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, RS, Brazil