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

Not Applicable

Recruiting

• Conditions: Diastolic Function; Endothelial Function; Heart Failure; Exercise Capacity; Physical Exercise; Arterial Stiffness
• Interventions: Behavioral: Combined exercise; Behavioral: High interval training

• Registration Number: NCT05726474
• Lead Sponsor: University of Castilla-La Mancha

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-20
• Study Start: 2023-01-23
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-02
• Study First Posted: 2023-02-14
• Last Update Submitted: 2023-02-14
• Last Update Posted: 2023-02-16
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combined exercise	Combined exercise	-
High interval training	High interval training	-

Primary Outcome Measures

Name	Time	Method
E velocity	Change from Baseline E velocity at 3 months	E velocity in m/s
E/e' ratio	Change from Baseline E/e' ratio at 3 months	E/e' ratio
E/A ratio	Change from Baseline E/A ratio at 3 months	E/A ratio
e' velocity	Change from Baseline e' velocity in m/s at 3 months	e' velocity in m/s
Exercise capacity	Change from Baseline exercise capacity at 3 months	Maximal cardiopulmonary stress test with Ergoline600 ergometer bicycle.
Endothelial function	Change from Baseline endothelial function at 3 months	Carotid intima-media thickness: by ultrasound with the Sonosite SII device.
Arterial stiffness	Change from Baseline arterial stiffness at 3 months	Pulse wave velocity and augmentation index
A velocity	Change from Baseline A velocity at 3 months	A velocity in m/s
ejection fraction	Change from Baseline ejection fraction at 3 months	percentage of ejection fraction
left ventricular volume index	Change from Baseline left ventricular volume index at 3 months	left ventricular volume index
end-diastolic volume	Change from Baseline end-diastolic volume at 3 months	end-diastolic volume
left ventricular mass	Change from Baseline left ventricular mass at 3 months	left ventricular mass
left atrial diameter	Change from Baseline left atrial diameter at 3 months	left atrial diameter
isovolume relaxation time	Change from Baseline isovolume relaxation time at 3 months	isovolume relaxation time in seg
deceleration time	Change from Baseline deceleration time at 3 months	deceleration time in m/s
left atrial volume index	Change from Baseline left atrial volume index at 3 months	left atrial volume index

Secondary Outcome Measures

Name	Time	Method
Patient's medical history	Baseline	Comorbidities and medication
Weight	Change from Baseline weight at 3 months	Weight in kilogram
Sociodemographic variables	Baseline	Age, sex and socioeconomic level
Muscular strength	Change from Baseline Muscular strength at 3 months	Handgrip force to be determined with TKK 5401 Grip-D dynamometer.
Spirometry	Change from Baseline spirometry at 3 months	Forced vital capacity (FVC), forced expiratory volume in the first second (FEV1) and FEV1/FVC ratio.
Glucose	Change from Baseline Glucose at 3 months	Glucose
Physical activity	Change from Baseline phisical activity at 3 months	Accelerometry. Time of physical activity
HQoL	Change from Baseline HQoL at 3 months	Validated 12-item health questionnaire (SF-12). From 0 to 12 (higher values better HQoL)
Adherence to the Mediterranean diet	Change from Baseline Adherence to the Mediterranean diet at 3 months	Validated 14-item questionnaire on adherence to the Mediterranean diet (MEDAS-14). From 0 to 14 (higher values better Adherence)
height	Change from Baseline height at 3 months	height in centimeters
BMI	Change from Baseline BMI at 3 months	BMI in kg/m2
waist circumference	Change from Baseline waist circumference at 3 months	waist circumference in cm
body fat	Change from Baseline body fat at 3 months	percentage of body fat
blood pressure	Change from Baseline blood pressure at 3 months	systolic and diastolic blood pressure in mmHg
total cholesterol	Change from Baseline total cholesterol at 6 months	total cholesterol
triglycerides	Change from Baseline triglycerides at 6 months	triglycerides
HDL-cholesterol	Change from Baseline HDL-cholesterol at 6 months	HDL-cholesterol
LDL-cholesterol	Change from Baseline LDL-cholesterol at 6 months	LDL-cholesterol
apolipoproteins A1 and B	Change from Baseline apolipoproteins A1 and B at 6 months	apolipoproteins A1 and B
insulin	Change from Baseline insulin at 6 months	insulin
ultra-sensitive C-reactive protein	Change from Baseline ultra-sensitive C-reactive protein at 6 months	ultra-sensitive C-reactive protein
N-terminal pro-B-type natriuretic peptide (NT-proBNP)	Change from Baseline N-terminal pro-B-type natriuretic peptide (NT-proBNP) at 6 months	N-terminal pro-B-type natriuretic peptide (NT-proBNP)
HbA1c	Change from Baseline HbA1c at 6 months	HbA1c

Trial Locations

Locations (1)

Universidad de Castulla-La Mancha; 🇪🇸 Cuenca, Spain