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

Study Overview
=================
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.

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

Conditions
-----------------
Heart Failure, Diastolic Heart Failure

Intervention / Treatment
-----------------
* Behavioral: High Intensity Interval Training
* Behavioral: Moderate Continuous Training


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High intensity interval training<br>exercise protocol for high intensity/aerobic interval training as described by ESC statement (Mezzani et al.) | Behavioral: High Intensity Interval Training<br>* 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.<br>|
| Placebo Comparator: Moderate Continuous Training<br>exercise protocol for continuous aerobic training as described by ESC statement (Mezzani et al.) | Behavioral: Moderate Continuous Training<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal Oxygen Consumption |  | 12 weeks after beginning of training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diastolic Function | assessed by echocardiography | 12 weeks after beginning of training | 
| Pulmonary function tests | assessed by spirometry | 12 weeks after beginning of training | 
| Respiratory muscle strength | assessed by manovacuometry | 12 weeks after beginning of training | 
| Quality of life | Minnesota Living with Heart Failure Questionnaire | 12 weeks after beginning of training |