title: Inspiratory Muscle Training and Functional Electrical Stimulation for Treatment of Heart Failure With Preserved Ejection Fraction: Rationale and Study Design of a Prospective Randomized Controlled Trial.
abstract: Heart failure with preserved ejection fraction (HFpEF) has become the most prevalent form of heart failure in developed countries. Regrettably, there is no evidence-based effective therapy for HFpEF. We seek to evaluate whether inspiratory muscle training, functional electrical stimulation, or a combination of both can improve exercise capacity as well as left ventricular diastolic function, biomarker profile, quality of life (QoL), and prognosis in patients with HFpEF. A total of 60 stable symptomatic patients with HFpEF (New York Heart Association class II-III/IV) will be randomized (1:1:1:1) to receive a 12-week program of inspiratory muscle training, functional electrical stimulation, a combination of both, or standard care alone. The primary endpoint of the study is change in peak exercise oxygen uptake; secondary endpoints are changes in QoL, echocardiogram parameters, and prognostic biomarkers. As of March 21, 2016, thirty patients have been enrolled. Searching for novel therapies that improve QoL and autonomy in the elderly with HFpEF has become a health care priority. We believe that this study will add important knowledge about the potential utility of 2 simple and feasible physical interventions for the treatment of advanced HFpEF.
authors.affiliation: Cardiology Department, Hospital de La Plana, Universitat Jaume I, Castellón, Spain.
authors.forename: Patricia
authors.initials: P
authors.lastname: Palau
authors.affiliation: Cardiology Department, Hospital General de Castellón, Universitat Jaume I, Castellón, Spain.
authors.forename: Eloy
authors.initials: E
authors.lastname: Domínguez
authors.affiliation: Department of Physiotherapy, Universitat de València, Valencia, Spain.
authors.forename: Laura
authors.initials: L
authors.lastname: López
authors.affiliation: Cardiology Department, Hospital Clínico Universitario-INCLIVA, Universitat de València, Valencia, Spain.
authors.forename: Raquel
authors.initials: R
authors.lastname: Heredia
authors.affiliation: Cardiology Department, Hospital Clínico Universitario-INCLIVA, Universitat de València, Valencia, Spain.
authors.forename: Jessika
authors.initials: J
authors.lastname: González
authors.affiliation: Cardiology Department, Hospital Clínico Universitario-INCLIVA, Universitat de València, Valencia, Spain.
authors.forename: Jose María
authors.initials: JM
authors.lastname: Ramón
authors.affiliation: Department of Physiotherapy, Universitat de València, Valencia, Spain.
authors.forename: Pilar
authors.initials: P
authors.lastname: Serra
authors.affiliation: Cardiology Department, Hospital Clínico Universitario-INCLIVA, Universitat de València, Valencia, Spain.
authors.forename: Enrique
authors.initials: E
authors.lastname: Santas
authors.affiliation: Cardiology Department, Hospital Clínico Universitario-INCLIVA, Universitat de València, Valencia, Spain.
authors.forename: Vicente
authors.initials: V
authors.lastname: Bodi
authors.affiliation: Cardiology Department, Hospital Clínico Universitario-INCLIVA, Universitat de València, Valencia, Spain.
authors.forename: Juan
authors.initials: J
authors.lastname: Sanchis
authors.affiliation: Cardiology Department, Hospital Clínico Universitario-INCLIVA, Universitat de València, Valencia, Spain.
authors.forename: Francisco J
authors.initials: FJ
authors.lastname: Chorro
authors.affiliation: Cardiology Department, Hospital Clínico Universitario-INCLIVA, Universitat de València, Valencia, Spain.
authors.forename: Julio
authors.initials: J
authors.lastname: Núñez
mesh_terms: D000368:Aged; D015415:Biomarkers / Q000097:blood; D001945:Breathing Exercises / Q000009:adverse effects; D018394:CA-125 Antigen / Q000097:blood; D002985:Clinical Protocols; D003131:Combined Modality Therapy; D004452:Echocardiography; D004599:Electric Stimulation Therapy / Q000009:adverse effects; D017079:Exercise Tolerance; D005260:Female; D006333:Heart Failure / Q000097:blood / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D001239:Inhalation; D035002:Lower Extremity / Q000294:innervation*; D008297:Male; D008565:Membrane Proteins / Q000097:blood; D020097:Natriuretic Peptide, Brain / Q000097:blood; D010101:Oxygen Consumption; D010446:Peptide Fragments / Q000097:blood; D011446:Prospective Studies; D011788:Quality of Life; D020127:Recovery of Function; D012107:Research Design; D012132:Respiratory Muscles / Q000503:physiopathology*; D013030:Spain; D013318:Stroke Volume; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D016277:Ventricular Function, Left
chemical_list: D015415:Biomarkers; D018394:CA-125 Antigen; C451759:MUC16 protein, human; D008565:Membrane Proteins; D010446:Peptide Fragments; C109794:pro-brain natriuretic peptide (1-76); D020097:Natriuretic Peptide, Brain