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Inspiratory Muscle Training and Functional Electrical Stimulation for Treatment of Heart Failure With Preserved Ejection Fraction: The TRAINING-HF Trial.
Rev Esp Cardiol (Engl Ed) 2019; 72(4):288-297RE

Abstract

INTRODUCTION AND OBJECTIVES

Despite the prevalence of heart failure with preserved ejection fraction (HFpEF), there is currently no evidence-based effective therapy for this disease. This study sought to evaluate whether inspiratory muscle training (IMT), functional electrical stimulation (FES), or a combination of both (IMT + FES) improves 12- and 24-week exercise capacity as well as left ventricular diastolic function, biomarker profile, and quality of life in HFpEF.

METHODS

A total of 61 stable symptomatic patients (New York Heart Association II-III) with HFpEF were randomized (1:1:1:1) to receive a 12-week program of IMT, FES, or IMT + FES vs usual care. The primary endpoint of the study was to evaluate change in peak exercise oxygen uptake at 12 and 24 weeks. Secondary endpoints were changes in quality of life, echocardiogram parameters, and prognostic biomarkers. We used a mixed-effects model for repeated-measures to compare endpoints changes.

RESULTS

Mean age and peak exercise oxygen uptake were 74 ± 9 years and 9.9 ± 2.5mL/min/kg, respectively. The proportion of women was 58%. At 12 weeks, the mean increase in peak exercise oxygen uptake (mL/kg/min) compared with usual care was 2.98, 2.93, and 2.47 for IMT, FES, and IMT + FES, respectively (P < .001) and this beneficial effect persisted after 6 months (1.95, 2.08, and 1.56; P < .001). Significant increases in quality of life scores were found at 12 weeks (P < .001). No other changes were found.

CONCLUSIONS

In HFpEF patients with low aerobic capacity, IMT and FES were associated with a significant improvement in exercise capacity and quality of life. This trial was registered at ClinicalTrials.gov (Identifier: NCT02638961)..

Authors+Show Affiliations

Servicio de Cardiología, Hospital General Universitario de Castellón, Universitat Jaume I, Castellón, Spain.Servicio de Cardiología, Hospital General Universitario de Castellón, Universitat Jaume I, Castellón, Spain.Facultad de Fisioterapia, Departamento de Fisioterapia, Universitat de València, Valencia, Spain.Servicio de Cardiología, Hospital Clínico Universitario, INCLIVA, Universitat de València, CIBERCV, Valencia, Spain.Servicio de Cardiología, Hospital Clínico Universitario, INCLIVA, Universitat de València, CIBERCV, Valencia, Spain.Servicio de Cardiología, Hospital Clínico Universitario, INCLIVA, Universitat de València, CIBERCV, Valencia, Spain.Servicio de Cardiología, Hospital Clínico Universitario, INCLIVA, Universitat de València, CIBERCV, Valencia, Spain.Servicio de Cardiología, Hospital Clínico Universitario, INCLIVA, Universitat de València, CIBERCV, Valencia, Spain.Servicio de Cardiología, Hospital Clínico Universitario, INCLIVA, Universitat de València, CIBERCV, Valencia, Spain.Servicio de Cardiología, Hospital Clínico Universitario, INCLIVA, Universitat de València, CIBERCV, Valencia, Spain.Servicio de Cardiología, Hospital Clínico Universitario, INCLIVA, Universitat de València, CIBERCV, Valencia, Spain.Servicio de Cardiología, Hospital Universitario de San Juan, Universidad Miguel Hernández, CIBERCV, San Juan de Alicante, Alicante, Spain.Servicio de Cardiología, Hospital Clínico Universitario, INCLIVA, Universitat de València, CIBERCV, Valencia, Spain.Servicio de Cardiología, Hospital Clínico Universitario, INCLIVA, Universitat de València, CIBERCV, Valencia, Spain.Servicio de Cardiología, Unidad de Insuficiencia Cardiaca, Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain; Department of Medicine, Autonomous University of Barcelona, CIBERCV, Barcelona, Spain.Servicio de Cardiología, Unidad de Insuficiencia Cardiaca, Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain; Department of Medicine, Autonomous University of Barcelona, CIBERCV, Barcelona, Spain.Servicio de Cardiología, Hospital Clínico Universitario, INCLIVA, Universitat de València, CIBERCV, Valencia, Spain. Electronic address: yulnunez@gmail.com.

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng spa

PubMed ID

29551699

Citation

Palau, Patricia, et al. "Inspiratory Muscle Training and Functional Electrical Stimulation for Treatment of Heart Failure With Preserved Ejection Fraction: the TRAINING-HF Trial." Revista Espanola De Cardiologia (English Ed.), vol. 72, no. 4, 2019, pp. 288-297.
Palau P, Domínguez E, López L, et al. Inspiratory Muscle Training and Functional Electrical Stimulation for Treatment of Heart Failure With Preserved Ejection Fraction: The TRAINING-HF Trial. Rev Esp Cardiol (Engl Ed). 2019;72(4):288-297.
Palau, P., Domínguez, E., López, L., Ramón, J. M., Heredia, R., González, J., ... Núñez, J. (2019). Inspiratory Muscle Training and Functional Electrical Stimulation for Treatment of Heart Failure With Preserved Ejection Fraction: The TRAINING-HF Trial. Revista Espanola De Cardiologia (English Ed.), 72(4), pp. 288-297. doi:10.1016/j.rec.2018.01.010.
Palau P, et al. Inspiratory Muscle Training and Functional Electrical Stimulation for Treatment of Heart Failure With Preserved Ejection Fraction: the TRAINING-HF Trial. Rev Esp Cardiol (Engl Ed). 2019;72(4):288-297. PubMed PMID: 29551699.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Inspiratory Muscle Training and Functional Electrical Stimulation for Treatment of Heart Failure With Preserved Ejection Fraction: The TRAINING-HF Trial. AU - Palau,Patricia, AU - Domínguez,Eloy, AU - López,Laura, AU - Ramón,José María, AU - Heredia,Raquel, AU - González,Jessika, AU - Santas,Enrique, AU - Bodí,Vicent, AU - Miñana,Gema, AU - Valero,Ernesto, AU - Mollar,Anna, AU - Bertomeu González,Vicente, AU - Chorro,Francisco J, AU - Sanchis,Juan, AU - Lupón,Josep, AU - Bayés-Genís,Antoni, AU - Núñez,Julio, Y1 - 2018/03/16/ PY - 2017/09/09/received PY - 2018/01/29/accepted PY - 2018/3/20/pubmed PY - 2019/7/23/medline PY - 2018/3/20/entrez KW - Calidad de vida KW - Capacidad funcional KW - Exercise capacity KW - Heart failure with preserved ejection fraction KW - Insuficiencia cardiaca con función sistólica conservada KW - Physical therapy KW - Quality of life KW - Terapia física SP - 288 EP - 297 JF - Revista espanola de cardiologia (English ed.) JO - Rev Esp Cardiol (Engl Ed) VL - 72 IS - 4 N2 - INTRODUCTION AND OBJECTIVES: Despite the prevalence of heart failure with preserved ejection fraction (HFpEF), there is currently no evidence-based effective therapy for this disease. This study sought to evaluate whether inspiratory muscle training (IMT), functional electrical stimulation (FES), or a combination of both (IMT + FES) improves 12- and 24-week exercise capacity as well as left ventricular diastolic function, biomarker profile, and quality of life in HFpEF. METHODS: A total of 61 stable symptomatic patients (New York Heart Association II-III) with HFpEF were randomized (1:1:1:1) to receive a 12-week program of IMT, FES, or IMT + FES vs usual care. The primary endpoint of the study was to evaluate change in peak exercise oxygen uptake at 12 and 24 weeks. Secondary endpoints were changes in quality of life, echocardiogram parameters, and prognostic biomarkers. We used a mixed-effects model for repeated-measures to compare endpoints changes. RESULTS: Mean age and peak exercise oxygen uptake were 74 ± 9 years and 9.9 ± 2.5mL/min/kg, respectively. The proportion of women was 58%. At 12 weeks, the mean increase in peak exercise oxygen uptake (mL/kg/min) compared with usual care was 2.98, 2.93, and 2.47 for IMT, FES, and IMT + FES, respectively (P < .001) and this beneficial effect persisted after 6 months (1.95, 2.08, and 1.56; P < .001). Significant increases in quality of life scores were found at 12 weeks (P < .001). No other changes were found. CONCLUSIONS: In HFpEF patients with low aerobic capacity, IMT and FES were associated with a significant improvement in exercise capacity and quality of life. This trial was registered at ClinicalTrials.gov (Identifier: NCT02638961).. SN - 1885-5857 UR - https://www.unboundmedicine.com/medline/citation/29551699/Inspiratory_Muscle_Training_and_Functional_Electrical_Stimulation_for_Treatment_of_Heart_Failure_With_Preserved_Ejection_Fraction:_The_TRAINING_HF_Trial_ L2 - http://www.revespcardiol.org/en/linksolver/ft/pii/S1885-5857(18)30038-0 DB - PRIME DP - Unbound Medicine ER -