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Effect of Exercise Training in Patients with Chronotropic Incompetence and Heart Failure with Preserved Ejection Fraction: Training-HR Study Protocol

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Title: Effect of Exercise Training in Patients with Chronotropic Incompetence and Heart Failure with Preserved Ejection Fraction: Training-HR Study Protocol
Authors: Palau Sampio, Patricia, Flor Rufino, Cristina, Casaña Granell, José, Calatayud Villalba, Joaquín, Ortega Pérez de Villar, Lucía, Marín Vivanco, Paloma, López Bueno, Laura
Source: Palau Sampio, Patricia Flor Rufino, Cristina Casaña Granell, José Calatayud Villalba, Joaquín Ortega Pérez de Villar, Lucía Marín-Vivanco, Paloma López Bueno, Laura 2024 Effect of Exercise Training in Patients with Chronotropic Incompetence and Heart Failure with Preserved Ejection Fraction: Training-HR Study Protocol Current Problems in Cardiology 49 12 Art. 102839
RODERIC. Repositorio Institucional de la Universitat de València
Universitat de València
Publisher Information: 2025.
Publication Year: 2025
Subject Terms: cor malalties pacients rehabilitació, exercici terapèutic
Description: Background: Chronotropic incompetence (ChI) is linked with diminished exercise capacity in heart failure with preserved ejection fraction (HFpEF). Although exercise training has shown potential for improving functional capacity, the exercise modality associated with greater functional and chronotropic response (ChR) is not well-known. Additionally, how the ChR from different exercise modalities mediates functional improvement remains to be determined. This study aimed to evaluate the effect of three different exercise programs over current guideline recommendations on peak oxygen consumption (peakVO2) in patients with ChI HFpEF phenotype. Methods and results: In this randomized clinical trial, 80 stable symptomatic patients with HFpEF and ChI (NYHA class II-III/IV) are randomized (1:1:1:1) to receive: a) a 12-week program of supervised aerobic training (AT), b) AT and low to moderate-intensity strength training, c)AT and moderate to high-intensity strength training, or d) guideline-based physical activity and exercise recommendations. The primary endpoint is 12-week changes in peakVO2. The secondary endpoints are 12-week changes in ChR, 12-week changes in quality of life, and how ChR changes mediate changes in peakVO2. A mixed-effects model for repeated measures will be used to compare endpoint changes. The mean age is 75.1 ± 7.2 years, and most patients are women (57.5 %) in New York Heart Association functional class II (68.7 %). The mean peakVO2, percent of predicted peakVO2, and ChR are 11.8 ± 2.6 mL/kg/min, 67.2 ± 14.7 %, and 0.39 ± 0.16, respectively. No significant baseline clinical differences between arms are found. Conclusions: Training-HR will evaluate the effects of different exercise-based therapies on peakVO2, ChR, and quality of life in patients with ChI HFpEF phenotype. Clinical trial registration: ClinicalTrials.gov (NCT05649787).
Document Type: Article
File Description: application/pdf
Language: English
Access URL: https://hdl.handle.net/10550/104493
Accession Number: edsair.RECOLECTA.....e45f066b7b4fd5887de67a125c989f20
Database: OpenAIRE
Description
Abstract:Background: Chronotropic incompetence (ChI) is linked with diminished exercise capacity in heart failure with preserved ejection fraction (HFpEF). Although exercise training has shown potential for improving functional capacity, the exercise modality associated with greater functional and chronotropic response (ChR) is not well-known. Additionally, how the ChR from different exercise modalities mediates functional improvement remains to be determined. This study aimed to evaluate the effect of three different exercise programs over current guideline recommendations on peak oxygen consumption (peakVO2) in patients with ChI HFpEF phenotype. Methods and results: In this randomized clinical trial, 80 stable symptomatic patients with HFpEF and ChI (NYHA class II-III/IV) are randomized (1:1:1:1) to receive: a) a 12-week program of supervised aerobic training (AT), b) AT and low to moderate-intensity strength training, c)AT and moderate to high-intensity strength training, or d) guideline-based physical activity and exercise recommendations. The primary endpoint is 12-week changes in peakVO2. The secondary endpoints are 12-week changes in ChR, 12-week changes in quality of life, and how ChR changes mediate changes in peakVO2. A mixed-effects model for repeated measures will be used to compare endpoint changes. The mean age is 75.1 ± 7.2 years, and most patients are women (57.5 %) in New York Heart Association functional class II (68.7 %). The mean peakVO2, percent of predicted peakVO2, and ChR are 11.8 ± 2.6 mL/kg/min, 67.2 ± 14.7 %, and 0.39 ± 0.16, respectively. No significant baseline clinical differences between arms are found. Conclusions: Training-HR will evaluate the effects of different exercise-based therapies on peakVO2, ChR, and quality of life in patients with ChI HFpEF phenotype. Clinical trial registration: ClinicalTrials.gov (NCT05649787).