Comparison of the Effect of Two Types of Physical Exercise on the Improvement of Exercise Capacity, Diastolic Function, Endothelial Function, and Arterial Stiffness in Patients With Heart Failure With Preserved Ejection Fraction (ExIC-FEp Study)
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Heart Failure
- 发起方
- University of Castilla-La Mancha
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Exercise capacity
- 状态
- 已完成
- 最后更新
- 11个月前
概览
简要总结
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.
研究者
入排标准
入选标准
- •Heart Failure with preserved ejection fraction picture (diagnosis according to ESC 2021 criteria)
- •Signs and symptoms of Heart Failure
- •A left ventricular ejection fraction of ≥50%.
- •Objective evidence of cardiac structural and/or functional abnormalities consistent with the presence of left ventricular diastolic dysfunction/elevated left ventricular filling pressures, including elevated natriuretic peptides.
- •Sedentary men and women (structured exercise \<2 x 30 min/week).
- •Age ≥40 years
- •Written informed consent
- •Clinically stable for 6 weeks
- •Optimal medical treatment for ≥6 weeks
排除标准
- •Non-cardiac causes of heart failure symptoms:
- •Significant valvular or coronary artery disease - Uncontrolled hypertension or arrhythmias.
- •Primary cardiomyopathies
- •Significant pulmonary disease (FEV1\<50% predicted, GOLD III-IV)
- •Inability to exercise or conditions that may interfere with exercise intervention.
- •Myocardial infarction in the last 3 months
- •Signs of ischaemia during maximal cardiopulmonary exercise test.
- •Comorbidity that may influence one-year prognosis
- •Participation in another clinical trial.
结局指标
主要结局
Exercise capacity
时间窗: Change from Baseline exercise capacity at 3 months
Maximal cardiopulmonary stress test with Ergoline600 ergometer bicycle.
E velocity
时间窗: Change from Baseline E velocity at 3 months
E velocity in m/s
Endothelial function
时间窗: Change from Baseline endothelial function at 3 months
Carotid intima-media thickness: by ultrasound with the Sonosite SII device.
Arterial stiffness
时间窗: Change from Baseline arterial stiffness at 3 months
Pulse wave velocity and augmentation index
A velocity
时间窗: Change from Baseline A velocity at 3 months
A velocity in m/s
isovolume relaxation time
时间窗: Change from Baseline isovolume relaxation time at 3 months
isovolume relaxation time in seg
deceleration time
时间窗: Change from Baseline deceleration time at 3 months
deceleration time in m/s
E/A ratio
时间窗: Change from Baseline E/A ratio at 3 months
E/A ratio
e' velocity
时间窗: Change from Baseline e' velocity in m/s at 3 months
e' velocity in m/s
E/e' ratio
时间窗: Change from Baseline E/e' ratio at 3 months
E/e' ratio
ejection fraction
时间窗: Change from Baseline ejection fraction at 3 months
percentage of ejection fraction
left ventricular volume index
时间窗: Change from Baseline left ventricular volume index at 3 months
left ventricular volume index
end-diastolic volume
时间窗: Change from Baseline end-diastolic volume at 3 months
end-diastolic volume
left ventricular mass
时间窗: Change from Baseline left ventricular mass at 3 months
left ventricular mass
left atrial diameter
时间窗: Change from Baseline left atrial diameter at 3 months
left atrial diameter
left atrial volume index
时间窗: Change from Baseline left atrial volume index at 3 months
left atrial volume index
次要结局
- Glucose(Change from Baseline Glucose at 3 months)
- Sociodemographic variables(Baseline)
- Patient's medical history(Baseline)
- Weight(Change from Baseline weight at 3 months)
- Muscular strength(Change from Baseline Muscular strength at 3 months)
- Spirometry(Change from Baseline spirometry at 3 months)
- Physical activity(Change from Baseline phisical activity at 3 months)
- HQoL(Change from Baseline HQoL at 3 months)
- Adherence to the Mediterranean diet(Change from Baseline Adherence to the Mediterranean diet at 3 months)
- height(Change from Baseline height at 3 months)
- BMI(Change from Baseline BMI at 3 months)
- waist circumference(Change from Baseline waist circumference at 3 months)
- body fat(Change from Baseline body fat at 3 months)
- blood pressure(Change from Baseline blood pressure at 3 months)
- total cholesterol(Change from Baseline total cholesterol at 6 months)
- triglycerides(Change from Baseline triglycerides at 6 months)
- HDL-cholesterol(Change from Baseline HDL-cholesterol at 6 months)
- LDL-cholesterol(Change from Baseline LDL-cholesterol at 6 months)
- apolipoproteins A1 and B(Change from Baseline apolipoproteins A1 and B at 6 months)
- insulin(Change from Baseline insulin at 6 months)
- ultra-sensitive C-reactive protein(Change from Baseline ultra-sensitive C-reactive protein at 6 months)
- N-terminal pro-B-type natriuretic peptide (NT-proBNP)(Change from Baseline N-terminal pro-B-type natriuretic peptide (NT-proBNP) at 6 months)
- HbA1c(Change from Baseline HbA1c at 6 months)