NCT05726474: ExIC-FEp

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

Completed NA Last updated 4 June 2025

What this trial tests

NA trial testing Combined exercise in Heart Failure in 72 participants. Completed in 15 May 2025.

Timeline

23 January 2023

Primary endpoint
30 September 2024

15 May 2025

Quick facts

Lead sponsor	University of Castilla-La Mancha
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	72
Start date	23 January 2023
Primary completion	30 September 2024
Estimated completion	15 May 2025
Sites	1 location across Spain

Drugs / interventions tested

• Combined exercise
• High interval training

Conditions studied

• Heart Failure — all drugs for Heart Failure →
• Physical Exercise — all drugs for Physical Exercise →
• Exercise Capacity — all drugs for Exercise Capacity →
• Diastolic Function — all drugs for Diastolic Function →

Sponsor

University of Castilla-La Mancha

Who can join

40 and older, any sex, with Heart Failure or Physical Exercise. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Accuracy of the 6-Minute Walk Test for Assessing Functional Capacity in Patients With Heart Failure With Preserved Ejection Fraction and Other Chronic Cardiac Pathologies: Results of the ExIC-FEp Trial and a Meta-Analysis.
   Cavero-Redondo I, Saz-Lara A, Bizzozero-Peroni B, Núñez-Martínez L, et al · · 2024 · cited 7× · PMID 38886304 · DOI 10.1186/s40798-024-00740-6
2. Comparative Effect of Two Types of Physical Exercise for the Improvement of Exercise Capacity, Diastolic Function, Endothelial Function and Arterial Stiffness in Participants with Heart Failure with Preserved Ejection Fraction (ExIC-FEp Study): Protocol for a Randomized Controlle
   Cavero-Redondo I, Saz-Lara A, Martínez-García I, Bizzozero-Peroni B, et al · · 2023 · cited 4× · PMID 37240641 · DOI 10.3390/jcm12103535