Overview

This trial is active, not recruiting.

Conditions heart failure, diastolic heart failure
Treatments high intensity interval training, moderate continuous training
Sponsor Hospital de Clinicas de Porto Alegre
Start date June 2014
End date March 2017
Trial size 20 participants
Trial identifier NCT02916225, 140362

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
exercise protocol for high intensity/aerobic interval training as described by ESC statement (Mezzani et al.)
high intensity interval training
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.
(Placebo Comparator)
exercise protocol for continuous aerobic training as described by ESC statement (Mezzani et al.)
moderate continuous training
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.

Primary Outcomes

Measure
Maximal Oxygen Consumption
time frame: 12 weeks after beginning of training

Secondary Outcomes

Measure
Diastolic Function
time frame: 12 weeks after beginning of training
Pulmonary function tests
time frame: 12 weeks after beginning of training
Respiratory muscle strength
time frame: 12 weeks after beginning of training
Quality of life
time frame: 12 weeks after beginning of training

Eligibility Criteria

Male or female participants from 35 years up to 75 years old.

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.

Additional Information

Official title High Intensity Interval Training Versus Moderate Continuous Training in Heart Failure With Preserved Ejection Fraction Patients: a Randomized Study.
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Hospital de Clinicas de Porto Alegre.