Comparison of the Effect of Two Types of Physical Exercises in Patients With Heart Failure With Preserved Ejection Fraction

Heart Failure Clinical Trial

— ExIC-FEp  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05726474
• Other study ID #: SBPLY/21/180501/000112
• Status: Recruiting
• Phase: N/A
• Start date: January 23, 2023
• Est. completion date: September 2024

Study information

• Verified date: February 2023
• Source: University of Castilla-La Mancha
• Contact: Iván Cavero-Redondo, PhD
• Phone: +34675558830
• Email: ivan.cavero[@]uclm.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

1. Heart Failure with preserved ejection fraction picture (diagnosis according to ESC 2021 criteria)

1. Signs and symptoms of Heart Failure

2. A left ventricular ejection fraction of =50%.

3. 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.

2. Sedentary men and women (structured exercise <2 x 30 min/week).

3. Age =40 years

4. Written informed consent

5. Clinically stable for 6 weeks

6. Optimal medical treatment for =6 weeks

Exclusion Criteria:

1. Non-cardiac causes of heart failure symptoms:

• Significant valvular or coronary artery disease - Uncontrolled hypertension or arrhythmias.

• Primary cardiomyopathies

2. Significant pulmonary disease (FEV1<50% predicted, GOLD III-IV)

3. Inability to exercise or conditions that may interfere with exercise intervention.

4. Myocardial infarction in the last 3 months

5. Signs of ischaemia during maximal cardiopulmonary exercise test.

6. Comorbidity that may influence one-year prognosis 7. Participation in another clinical trial.

Related Conditions & MeSH terms

• Arterial Stiffness
• Diastolic Function
• Endothelial Function
• Exercise Capacity
• Heart Failure
• Physical Exercise

Intervention

Behavioral:
• Combined exercise
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.
• High interval training
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.

Locations

Country	Name	City	State
Spain	Universidad de Castulla-La Mancha	Cuenca

Sponsors (1)

Lead Sponsor	Collaborator
University of Castilla-La Mancha

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise capacity	Maximal cardiopulmonary stress test with Ergoline600 ergometer bicycle.	Change from Baseline exercise capacity at 3 months
Primary	E velocity	E velocity in m/s	Change from Baseline E velocity at 3 months
Primary	Endothelial function	Carotid intima-media thickness: by ultrasound with the Sonosite SII device.	Change from Baseline endothelial function at 3 months
Primary	Arterial stiffness	Pulse wave velocity and augmentation index	Change from Baseline arterial stiffness at 3 months
Primary	A velocity	A velocity in m/s	Change from Baseline A velocity at 3 months
Primary	E/A ratio	E/A ratio	Change from Baseline E/A ratio at 3 months
Primary	e' velocity	e' velocity in m/s	Change from Baseline e' velocity in m/s at 3 months
Primary	E/e' ratio	E/e' ratio	Change from Baseline E/e' ratio at 3 months
Primary	ejection fraction	percentage of ejection fraction	Change from Baseline ejection fraction at 3 months
Primary	left ventricular volume index	left ventricular volume index	Change from Baseline left ventricular volume index at 3 months
Primary	end-diastolic volume	end-diastolic volume	Change from Baseline end-diastolic volume at 3 months
Primary	left ventricular mass	left ventricular mass	Change from Baseline left ventricular mass at 3 months
Primary	left atrial diameter	left atrial diameter	Change from Baseline left atrial diameter at 3 months
Primary	isovolume relaxation time	isovolume relaxation time in seg	Change from Baseline isovolume relaxation time at 3 months
Primary	deceleration time	deceleration time in m/s	Change from Baseline deceleration time at 3 months
Primary	left atrial volume index	left atrial volume index	Change from Baseline left atrial volume index at 3 months
Secondary	Sociodemographic variables	Age, sex and socioeconomic level	Baseline
Secondary	Patient's medical history	Comorbidities and medication	Baseline
Secondary	Weight	Weight in kilogram	Change from Baseline weight at 3 months
Secondary	Muscular strength	Handgrip force to be determined with TKK 5401 Grip-D dynamometer.	Change from Baseline Muscular strength at 3 months
Secondary	Spirometry	Forced vital capacity (FVC), forced expiratory volume in the first second (FEV1) and FEV1/FVC ratio.	Change from Baseline spirometry at 3 months
Secondary	Glucose	Glucose	Change from Baseline Glucose at 3 months
Secondary	Physical activity	Accelerometry. Time of physical activity	Change from Baseline phisical activity at 3 months
Secondary	HQoL	Validated 12-item health questionnaire (SF-12). From 0 to 12 (higher values better HQoL)	Change from Baseline HQoL at 3 months
Secondary	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)	Change from Baseline Adherence to the Mediterranean diet at 3 months
Secondary	height	height in centimeters	Change from Baseline height at 3 months
Secondary	BMI	BMI in kg/m2	Change from Baseline BMI at 3 months
Secondary	waist circumference	waist circumference in cm	Change from Baseline waist circumference at 3 months
Secondary	body fat	percentage of body fat	Change from Baseline body fat at 3 months
Secondary	blood pressure	systolic and diastolic blood pressure in mmHg	Change from Baseline blood pressure at 3 months
Secondary	total cholesterol	total cholesterol	Change from Baseline total cholesterol at 6 months
Secondary	triglycerides	triglycerides	Change from Baseline triglycerides at 6 months
Secondary	HDL-cholesterol	HDL-cholesterol	Change from Baseline HDL-cholesterol at 6 months
Secondary	LDL-cholesterol	LDL-cholesterol	Change from Baseline LDL-cholesterol at 6 months
Secondary	apolipoproteins A1 and B	apolipoproteins A1 and B	Change from Baseline apolipoproteins A1 and B at 6 months
Secondary	insulin	insulin	Change from Baseline insulin at 6 months
Secondary	ultra-sensitive C-reactive protein	ultra-sensitive C-reactive protein	Change from Baseline ultra-sensitive C-reactive protein at 6 months
Secondary	N-terminal pro-B-type natriuretic peptide (NT-proBNP)	N-terminal pro-B-type natriuretic peptide (NT-proBNP)	Change from Baseline N-terminal pro-B-type natriuretic peptide (NT-proBNP) at 6 months
Secondary	HbA1c	HbA1c	Change from Baseline HbA1c at 6 months