Background: Heart failure (HF) is a chronic disease with a very important and increasingly severe social and health impact with a prevalence of 6.8% in Spain. HF with preserved ejection fraction (HFpEF) represents approximately 50% of all patients with HF. In the absence of pharmacological treatments that have succeeded in reducing mortality or morbidity in this pathology, it is recommended that interventions be directed at prevention, symptomatic treatment of HF and treatment of comorbidities to avoid exacerbations, thus physical exercise is recognized as an important adjunct in the treatment of HF and is recommended by the guidelines of the American College of Cardiology (ACC)/American Heart Association (AHA) and the European Society of Cardiology (ESC). Currently, aerobic exercise is the most studied physical exercise in this population, but in recent years high-intensity interval training (HIIT) and the combination of aerobic exercise with strength training (combined exercise) have emerged. Objectives: The overall objective of this study is to compare the effectiveness of combined training and HIIT on exercise capacity, diastolic function, endothelial function, and arterial stiffness in patients with HFpEF. The specific objectives of this study are: a) to compare the effectiveness of combined training and HIIT on quality of life in patients with HFpEF and b) to analyze the cost-effectiveness of combined training and HIIT versus conventional treatment in patients with HFpEF. Methodology: The ExIC-FEp study will be a single-blind randomized clinical trial with 3 arms (combined exercise, HIIT and a control group), conducted at the Health and Social Research Center of the University of Castilla-La Mancha, to analyze two types of supervised physical exercise in patients with HFpEF for 6 months. Patients with HFpEF will be randomly assigned (1:1:1) to the combined exercise, HIIT or control group. All participants will be examined, at baseline (prior to randomization), at three months (mid-intervention) and at six months (at the end of the intervention). Participants will undergo physical examination, echocardiography, maximal cardiopulmonary stress test, and measurement of endothelial function and arterial stiffness. In addition, sociodemographic variables, quality of life, physical activity, adherence to the Mediterranean diet, strength, spirometry and blood sampling will be measured. Expected scientific contributions: this randomized clinical trial will represent a a significant advance in the scientific evidence available on the efficacy of physical exercise in the treatment of HFpEF, through: (a) transfer of the results to physicians, nurses and patients; (b) dissemination of results through scientific articles, doctoral theses and participation in congresses; (c) press releases and press conferences with the aim of disseminating the research results to the population; (d) dissemination through social networks to improve the social impact; and (e) design and content development of a web page.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
72
Patients will exercise for 40 minutes three times a week on an ergometric bicycle at 50-60% of VO2max, 60-70% of HRmax, 11-13 on the Borg scale, without ergometer at 50-60% of VO2max, 60-70% of HRmax, 11-13 on the Borg scale, without shortness of breathing difficulty. In addition, strength training will be performed (bench press, leg press, leg curl, leg machine, bench press, leg press, leg curl, leg curl, leg machine). leg curls, leg curls, rowing machine, triceps dips, pectoral pull-ups) twice a week. week. Strength training will be performed with 15 repetitions per exercise and per session, with a corresponding workload of 15 repetitions. session, with a workload corresponding to 60% to 65% of the 1-repetition maximum (1RM) measured at (1RM) measured at the beginning and at the end of the intervention.
Patients will perform three training sessions per week. Each training session begins with a 10-minute warm-up at moderate intensity (corresponding to 50-60% of VO2max, 60-70% of HRmax, 11-13 on the Borg scale, no shortness of breath) before cycling, four 4-minute intervals at high intensity (corresponding to 85-90% of VO2max, 90-95% of HRmax, 15-17 on the Borg scale, shortness of breath). Each interval will be separated by 3 minutes of active pauses, with a HRmax of 50-70%. The training session will end with 3 minutes of cool down at moderate intensity (corresponding to 50-60%). moderate intensity (corresponding to 50-60% of VO2max, 60-70% of HRmax, 11-13 on the Borg scale, without difficulty). Borg scale, no shortness of breath). The total exercise time will be 40 minutes for the HIIT group.
Universidad de Castulla-La Mancha
Cuenca, Cuenca, Spain
Exercise capacity
Maximal cardiopulmonary stress test with Ergoline600 ergometer bicycle.
Time frame: Change from Baseline exercise capacity at 3 months
E velocity
E velocity in m/s
Time frame: Change from Baseline E velocity at 3 months
Endothelial function
Carotid intima-media thickness: by ultrasound with the Sonosite SII device.
Time frame: Change from Baseline endothelial function at 3 months
Arterial stiffness
Pulse wave velocity and augmentation index
Time frame: Change from Baseline arterial stiffness at 3 months
A velocity
A velocity in m/s
Time frame: Change from Baseline A velocity at 3 months
E/A ratio
E/A ratio
Time frame: Change from Baseline E/A ratio at 3 months
e' velocity
e' velocity in m/s
Time frame: Change from Baseline e' velocity in m/s at 3 months
E/e' ratio
E/e' ratio
Time frame: Change from Baseline E/e' ratio at 3 months
ejection fraction
percentage of ejection fraction
Time frame: Change from Baseline ejection fraction at 3 months
left ventricular volume index
left ventricular volume index
Time frame: Change from Baseline left ventricular volume index at 3 months
end-diastolic volume
end-diastolic volume
Time frame: Change from Baseline end-diastolic volume at 3 months
left ventricular mass
left ventricular mass
Time frame: Change from Baseline left ventricular mass at 3 months
left atrial diameter
left atrial diameter
Time frame: Change from Baseline left atrial diameter at 3 months
isovolume relaxation time
isovolume relaxation time in seg
Time frame: Change from Baseline isovolume relaxation time at 3 months
deceleration time
deceleration time in m/s
Time frame: Change from Baseline deceleration time at 3 months
left atrial volume index
left atrial volume index
Time frame: Change from Baseline left atrial volume index at 3 months
Sociodemographic variables
Age, sex and socioeconomic level
Time frame: Baseline
Patient's medical history
Comorbidities and medication
Time frame: Baseline
Weight
Weight in kilogram
Time frame: Change from Baseline weight at 3 months
Muscular strength
Handgrip force to be determined with TKK 5401 Grip-D dynamometer.
Time frame: Change from Baseline Muscular strength at 3 months
Spirometry
Forced vital capacity (FVC), forced expiratory volume in the first second (FEV1) and FEV1/FVC ratio.
Time frame: Change from Baseline spirometry at 3 months
Glucose
Glucose
Time frame: Change from Baseline Glucose at 3 months
Physical activity
Accelerometry. Time of physical activity
Time frame: Change from Baseline phisical activity at 3 months
HQoL
Validated 12-item health questionnaire (SF-12). From 0 to 12 (higher values better HQoL)
Time frame: Change from Baseline HQoL at 3 months
Adherence to the Mediterranean diet
Validated 14-item questionnaire on adherence to the Mediterranean diet (MEDAS-14). From 0 to 14 (higher values better Adherence)
Time frame: Change from Baseline Adherence to the Mediterranean diet at 3 months
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height
height in centimeters
Time frame: Change from Baseline height at 3 months
BMI
BMI in kg/m2
Time frame: Change from Baseline BMI at 3 months
waist circumference
waist circumference in cm
Time frame: Change from Baseline waist circumference at 3 months
body fat
percentage of body fat
Time frame: Change from Baseline body fat at 3 months
blood pressure
systolic and diastolic blood pressure in mmHg
Time frame: Change from Baseline blood pressure at 3 months
total cholesterol
total cholesterol
Time frame: Change from Baseline total cholesterol at 6 months
triglycerides
triglycerides
Time frame: Change from Baseline triglycerides at 6 months
HDL-cholesterol
HDL-cholesterol
Time frame: Change from Baseline HDL-cholesterol at 6 months
LDL-cholesterol
LDL-cholesterol
Time frame: Change from Baseline LDL-cholesterol at 6 months
apolipoproteins A1 and B
apolipoproteins A1 and B
Time frame: Change from Baseline apolipoproteins A1 and B at 6 months
insulin
insulin
Time frame: Change from Baseline insulin at 6 months
ultra-sensitive C-reactive protein
ultra-sensitive C-reactive protein
Time frame: Change from Baseline ultra-sensitive C-reactive protein at 6 months
N-terminal pro-B-type natriuretic peptide (NT-proBNP)
N-terminal pro-B-type natriuretic peptide (NT-proBNP)
Time frame: Change from Baseline N-terminal pro-B-type natriuretic peptide (NT-proBNP) at 6 months
HbA1c
HbA1c
Time frame: Change from Baseline HbA1c at 6 months