Effectiveness of a cardiac rehabilitation program on biomechanical, imaging, and physiological biomarkers in elderly patients with heart failure with preserved ejection fraction (HFpEF): FUNNEL + study protocol
Abstract Background Patients with heart failure with preserved ejection fraction (HFpEF) have a low functional status, which in turn is a risk factor for hospital admission and an important predictor of survival in HFpEF. HFpFE is a heterogeneous syndrome and recent studies have suggested an importa...
| Main Authors: | , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2023-11-01
|
| Series: | BMC Cardiovascular Disorders |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12872-023-03555-7 |
| _version_ | 1797630472054898688 |
|---|---|
| author | Antonio Ignacio Cuesta-Vargas Iván José Fuentes-Abolafio Celia García-Conejo Estíbaliz Díaz-Balboa Manuel Trinidad-Fernández Daniel Gutiérrez-Sánchez Adrián Escriche-Escuder Lidia Cobos-Palacios Almudena López-Sampalo Jose Maria Pérez-Ruíz Cristina Roldán-Jiménez Miguel Angel Pérez-Velasco Javier Mora-Robles Mª Dolores López-Carmona David Pérez-Cruzado Jaime Martín-Martín Luis Miguel Pérez-Belmonte |
| author_facet | Antonio Ignacio Cuesta-Vargas Iván José Fuentes-Abolafio Celia García-Conejo Estíbaliz Díaz-Balboa Manuel Trinidad-Fernández Daniel Gutiérrez-Sánchez Adrián Escriche-Escuder Lidia Cobos-Palacios Almudena López-Sampalo Jose Maria Pérez-Ruíz Cristina Roldán-Jiménez Miguel Angel Pérez-Velasco Javier Mora-Robles Mª Dolores López-Carmona David Pérez-Cruzado Jaime Martín-Martín Luis Miguel Pérez-Belmonte |
| author_sort | Antonio Ignacio Cuesta-Vargas |
| collection | DOAJ |
| description | Abstract Background Patients with heart failure with preserved ejection fraction (HFpEF) have a low functional status, which in turn is a risk factor for hospital admission and an important predictor of survival in HFpEF. HFpFE is a heterogeneous syndrome and recent studies have suggested an important role for careful, pathophysiological-based phenotyping to improve patient characterization. Cardiac rehabilitation has proven to be a useful tool in the framework of secondary prevention in patients with HFpEF. Facilitating decision-making and implementing cardiac rehabilitation programs is a challenge in public health systems for HFpEF management. The FUNNEL + study proposes to evaluate the efficacy of an exercise and education-based cardiac rehabilitation program on biomechanical, physiological, and imaging biomarkers in patients with HFpEF. Methods A randomised crossover clinical trial is presented among people older than 70 years with a diagnosis of HFpEF. The experimental group will receive a cardiac rehabilitation intervention for 12 weeks. Participants in the control group will receive one educational session per week for 12 weeks on HFpEF complications, functional decline, and healthy lifestyle habits. VO2peak is the primary outcome. Biomechanical, imaging and physiological biomarkers will be assessed as secondary outcomes. Outcomes will be assessed at baseline, 12 weeks, and 24 weeks. Discussion Identifying objective functional parameters indicative of HFpEF and the subsequent development of functional level stratification based on functional impairment ("biomechanical phenotypes") may help clinicians identify cardiac rehabilitation responders and non-responders and make future clinical decisions. In this way, future pharmacological and non-pharmacological interventions, such as exercise, could be improved and tailored to improve quality of life and prognosis and reducing patients' hospital readmissions, thereby reducing healthcare costs. Trial registration NCT05393362 (Clinicaltrials.gov). |
| first_indexed | 2024-03-11T11:08:35Z |
| format | Article |
| id | doaj.art-947c777909e5412c94cdb01aeaec153f |
| institution | Directory Open Access Journal |
| issn | 1471-2261 |
| language | English |
| last_indexed | 2024-03-11T11:08:35Z |
| publishDate | 2023-11-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cardiovascular Disorders |
| spelling | doaj.art-947c777909e5412c94cdb01aeaec153f2023-11-12T12:06:02ZengBMCBMC Cardiovascular Disorders1471-22612023-11-0123111110.1186/s12872-023-03555-7Effectiveness of a cardiac rehabilitation program on biomechanical, imaging, and physiological biomarkers in elderly patients with heart failure with preserved ejection fraction (HFpEF): FUNNEL + study protocolAntonio Ignacio Cuesta-Vargas0Iván José Fuentes-Abolafio1Celia García-Conejo2Estíbaliz Díaz-Balboa3Manuel Trinidad-Fernández4Daniel Gutiérrez-Sánchez5Adrián Escriche-Escuder6Lidia Cobos-Palacios7Almudena López-Sampalo8Jose Maria Pérez-Ruíz9Cristina Roldán-Jiménez10Miguel Angel Pérez-Velasco11Javier Mora-Robles12Mª Dolores López-Carmona13David Pérez-Cruzado14Jaime Martín-Martín15Luis Miguel Pérez-Belmonte16Grupo de Investigación Clinimetría F14, Instituto de Investigación Biomédica de Málaga y Plataforma en Nanomedicina (IBIMA-Bionand))Grupo de Investigación Clinimetría F14, Instituto de Investigación Biomédica de Málaga y Plataforma en Nanomedicina (IBIMA-Bionand))Grupo de Investigación Clinimetría F14, Instituto de Investigación Biomédica de Málaga y Plataforma en Nanomedicina (IBIMA-Bionand))Departamento de Fisioterapia, Facultad de Ciencias de La Salud, Universidad de Málaga, Andalucía TechGrupo de Investigación Clinimetría F14, Instituto de Investigación Biomédica de Málaga y Plataforma en Nanomedicina (IBIMA-Bionand))Grupo de Investigación Clinimetría F14, Instituto de Investigación Biomédica de Málaga y Plataforma en Nanomedicina (IBIMA-Bionand))Grupo de Investigación Clinimetría F14, Instituto de Investigación Biomédica de Málaga y Plataforma en Nanomedicina (IBIMA-Bionand))Grupo de Investigación Clinimetría F14, Instituto de Investigación Biomédica de Málaga y Plataforma en Nanomedicina (IBIMA-Bionand))Servicio de Medicina Interna, Hospital Regional Universitario de Málaga, Instituto de Investigación Biomédica de Málaga (IBIMA)Servicio de Cardiologia, Hospital Regional Universitario de Málaga, Instituto de Investigación Biomédica de Málaga (IBIMA)Grupo de Investigación Clinimetría F14, Instituto de Investigación Biomédica de Málaga y Plataforma en Nanomedicina (IBIMA-Bionand))Servicio de Medicina Interna, Hospital Regional Universitario de Málaga, Instituto de Investigación Biomédica de Málaga (IBIMA)Grupo de Investigación Clinimetría F14, Instituto de Investigación Biomédica de Málaga y Plataforma en Nanomedicina (IBIMA-Bionand))Grupo de Investigación Clinimetría F14, Instituto de Investigación Biomédica de Málaga y Plataforma en Nanomedicina (IBIMA-Bionand))Grupo de Investigación Clinimetría F14, Instituto de Investigación Biomédica de Málaga y Plataforma en Nanomedicina (IBIMA-Bionand))Grupo de Investigación Clinimetría F14, Instituto de Investigación Biomédica de Málaga y Plataforma en Nanomedicina (IBIMA-Bionand))Grupo de Investigación Clinimetría F14, Instituto de Investigación Biomédica de Málaga y Plataforma en Nanomedicina (IBIMA-Bionand))Abstract Background Patients with heart failure with preserved ejection fraction (HFpEF) have a low functional status, which in turn is a risk factor for hospital admission and an important predictor of survival in HFpEF. HFpFE is a heterogeneous syndrome and recent studies have suggested an important role for careful, pathophysiological-based phenotyping to improve patient characterization. Cardiac rehabilitation has proven to be a useful tool in the framework of secondary prevention in patients with HFpEF. Facilitating decision-making and implementing cardiac rehabilitation programs is a challenge in public health systems for HFpEF management. The FUNNEL + study proposes to evaluate the efficacy of an exercise and education-based cardiac rehabilitation program on biomechanical, physiological, and imaging biomarkers in patients with HFpEF. Methods A randomised crossover clinical trial is presented among people older than 70 years with a diagnosis of HFpEF. The experimental group will receive a cardiac rehabilitation intervention for 12 weeks. Participants in the control group will receive one educational session per week for 12 weeks on HFpEF complications, functional decline, and healthy lifestyle habits. VO2peak is the primary outcome. Biomechanical, imaging and physiological biomarkers will be assessed as secondary outcomes. Outcomes will be assessed at baseline, 12 weeks, and 24 weeks. Discussion Identifying objective functional parameters indicative of HFpEF and the subsequent development of functional level stratification based on functional impairment ("biomechanical phenotypes") may help clinicians identify cardiac rehabilitation responders and non-responders and make future clinical decisions. In this way, future pharmacological and non-pharmacological interventions, such as exercise, could be improved and tailored to improve quality of life and prognosis and reducing patients' hospital readmissions, thereby reducing healthcare costs. Trial registration NCT05393362 (Clinicaltrials.gov).https://doi.org/10.1186/s12872-023-03555-7Heart failurePreserved ejection fractionSarcopeniaFrail elderly syndromeCardiovascular rehabilitationFunctional physical performance |
| spellingShingle | Antonio Ignacio Cuesta-Vargas Iván José Fuentes-Abolafio Celia García-Conejo Estíbaliz Díaz-Balboa Manuel Trinidad-Fernández Daniel Gutiérrez-Sánchez Adrián Escriche-Escuder Lidia Cobos-Palacios Almudena López-Sampalo Jose Maria Pérez-Ruíz Cristina Roldán-Jiménez Miguel Angel Pérez-Velasco Javier Mora-Robles Mª Dolores López-Carmona David Pérez-Cruzado Jaime Martín-Martín Luis Miguel Pérez-Belmonte Effectiveness of a cardiac rehabilitation program on biomechanical, imaging, and physiological biomarkers in elderly patients with heart failure with preserved ejection fraction (HFpEF): FUNNEL + study protocol BMC Cardiovascular Disorders Heart failure Preserved ejection fraction Sarcopenia Frail elderly syndrome Cardiovascular rehabilitation Functional physical performance |
| title | Effectiveness of a cardiac rehabilitation program on biomechanical, imaging, and physiological biomarkers in elderly patients with heart failure with preserved ejection fraction (HFpEF): FUNNEL + study protocol |
| title_full | Effectiveness of a cardiac rehabilitation program on biomechanical, imaging, and physiological biomarkers in elderly patients with heart failure with preserved ejection fraction (HFpEF): FUNNEL + study protocol |
| title_fullStr | Effectiveness of a cardiac rehabilitation program on biomechanical, imaging, and physiological biomarkers in elderly patients with heart failure with preserved ejection fraction (HFpEF): FUNNEL + study protocol |
| title_full_unstemmed | Effectiveness of a cardiac rehabilitation program on biomechanical, imaging, and physiological biomarkers in elderly patients with heart failure with preserved ejection fraction (HFpEF): FUNNEL + study protocol |
| title_short | Effectiveness of a cardiac rehabilitation program on biomechanical, imaging, and physiological biomarkers in elderly patients with heart failure with preserved ejection fraction (HFpEF): FUNNEL + study protocol |
| title_sort | effectiveness of a cardiac rehabilitation program on biomechanical imaging and physiological biomarkers in elderly patients with heart failure with preserved ejection fraction hfpef funnel study protocol |
| topic | Heart failure Preserved ejection fraction Sarcopenia Frail elderly syndrome Cardiovascular rehabilitation Functional physical performance |
| url | https://doi.org/10.1186/s12872-023-03555-7 |
| work_keys_str_mv | AT antonioignaciocuestavargas effectivenessofacardiacrehabilitationprogramonbiomechanicalimagingandphysiologicalbiomarkersinelderlypatientswithheartfailurewithpreservedejectionfractionhfpeffunnelstudyprotocol AT ivanjosefuentesabolafio effectivenessofacardiacrehabilitationprogramonbiomechanicalimagingandphysiologicalbiomarkersinelderlypatientswithheartfailurewithpreservedejectionfractionhfpeffunnelstudyprotocol AT celiagarciaconejo effectivenessofacardiacrehabilitationprogramonbiomechanicalimagingandphysiologicalbiomarkersinelderlypatientswithheartfailurewithpreservedejectionfractionhfpeffunnelstudyprotocol AT estibalizdiazbalboa effectivenessofacardiacrehabilitationprogramonbiomechanicalimagingandphysiologicalbiomarkersinelderlypatientswithheartfailurewithpreservedejectionfractionhfpeffunnelstudyprotocol AT manueltrinidadfernandez effectivenessofacardiacrehabilitationprogramonbiomechanicalimagingandphysiologicalbiomarkersinelderlypatientswithheartfailurewithpreservedejectionfractionhfpeffunnelstudyprotocol AT danielgutierrezsanchez effectivenessofacardiacrehabilitationprogramonbiomechanicalimagingandphysiologicalbiomarkersinelderlypatientswithheartfailurewithpreservedejectionfractionhfpeffunnelstudyprotocol AT adrianescricheescuder effectivenessofacardiacrehabilitationprogramonbiomechanicalimagingandphysiologicalbiomarkersinelderlypatientswithheartfailurewithpreservedejectionfractionhfpeffunnelstudyprotocol AT lidiacobospalacios effectivenessofacardiacrehabilitationprogramonbiomechanicalimagingandphysiologicalbiomarkersinelderlypatientswithheartfailurewithpreservedejectionfractionhfpeffunnelstudyprotocol AT almudenalopezsampalo effectivenessofacardiacrehabilitationprogramonbiomechanicalimagingandphysiologicalbiomarkersinelderlypatientswithheartfailurewithpreservedejectionfractionhfpeffunnelstudyprotocol AT josemariaperezruiz effectivenessofacardiacrehabilitationprogramonbiomechanicalimagingandphysiologicalbiomarkersinelderlypatientswithheartfailurewithpreservedejectionfractionhfpeffunnelstudyprotocol AT cristinaroldanjimenez effectivenessofacardiacrehabilitationprogramonbiomechanicalimagingandphysiologicalbiomarkersinelderlypatientswithheartfailurewithpreservedejectionfractionhfpeffunnelstudyprotocol AT miguelangelperezvelasco effectivenessofacardiacrehabilitationprogramonbiomechanicalimagingandphysiologicalbiomarkersinelderlypatientswithheartfailurewithpreservedejectionfractionhfpeffunnelstudyprotocol AT javiermorarobles effectivenessofacardiacrehabilitationprogramonbiomechanicalimagingandphysiologicalbiomarkersinelderlypatientswithheartfailurewithpreservedejectionfractionhfpeffunnelstudyprotocol AT madoloreslopezcarmona effectivenessofacardiacrehabilitationprogramonbiomechanicalimagingandphysiologicalbiomarkersinelderlypatientswithheartfailurewithpreservedejectionfractionhfpeffunnelstudyprotocol AT davidperezcruzado effectivenessofacardiacrehabilitationprogramonbiomechanicalimagingandphysiologicalbiomarkersinelderlypatientswithheartfailurewithpreservedejectionfractionhfpeffunnelstudyprotocol AT jaimemartinmartin effectivenessofacardiacrehabilitationprogramonbiomechanicalimagingandphysiologicalbiomarkersinelderlypatientswithheartfailurewithpreservedejectionfractionhfpeffunnelstudyprotocol AT luismiguelperezbelmonte effectivenessofacardiacrehabilitationprogramonbiomechanicalimagingandphysiologicalbiomarkersinelderlypatientswithheartfailurewithpreservedejectionfractionhfpeffunnelstudyprotocol |