Effectiveness of an intervention in multicomponent exercise in primary care to improve frailty parameters in patients over 70 years of age (MEFAP-project), a randomised clinical trial: rationale and study design

M V Castell, A Gutiérrez-Misis, M Sánchez-Martínez, M A Prieto, B Moreno, S Nuñez, R Triano, M P de Antonio, C Mateo, M D Cano, A Garrido, R Julian, E Polentinos, R Rodriguez-Barrientos, A Otero Puime, MEFAP Group, Virtudes Enguita Perez, Belen de la Fuente Martin, Raquel Carcerén Y Murciano, Rafael Ruiz Morote Aragón, Mª Victoria Diaz Puente, Elena Fernández García, Enma González Nespereira, Maria Luisa Asensio Ruiz, Elena Orio Moreno, Daniel Pascual Diez, Mercedes Piñeiro Rodriguez, Susana López Cotón, Eva María Illana, Maria Teresa Blanco Ramos, Maria Concepción Hernández de la Luna, Catalina Mª Santiago Gonzalez, Isabel Contreras Calzada, David Morales Tereja, Ana Maria Rosas Hernandez, Marta Agüero Martin, Verónica Andrés Sanz, Ricardo Duque Heras, Beatriz Carmen Durán Fernández, Rubén Escolano Garcia, Andrés Galeano Galeano Valiente, Maria Isabel Gallardo Vidal, Juliana García Cosmes, Maria Elena García López, Raquel García López, Belén Gómez Gómez, Maria Aurora Latorre Gálvez, Jose Luis Mijangos Rodriguez, Maria Luz Turégano Prieto, M V Castell, A Gutiérrez-Misis, M Sánchez-Martínez, M A Prieto, B Moreno, S Nuñez, R Triano, M P de Antonio, C Mateo, M D Cano, A Garrido, R Julian, E Polentinos, R Rodriguez-Barrientos, A Otero Puime, MEFAP Group, Virtudes Enguita Perez, Belen de la Fuente Martin, Raquel Carcerén Y Murciano, Rafael Ruiz Morote Aragón, Mª Victoria Diaz Puente, Elena Fernández García, Enma González Nespereira, Maria Luisa Asensio Ruiz, Elena Orio Moreno, Daniel Pascual Diez, Mercedes Piñeiro Rodriguez, Susana López Cotón, Eva María Illana, Maria Teresa Blanco Ramos, Maria Concepción Hernández de la Luna, Catalina Mª Santiago Gonzalez, Isabel Contreras Calzada, David Morales Tereja, Ana Maria Rosas Hernandez, Marta Agüero Martin, Verónica Andrés Sanz, Ricardo Duque Heras, Beatriz Carmen Durán Fernández, Rubén Escolano Garcia, Andrés Galeano Galeano Valiente, Maria Isabel Gallardo Vidal, Juliana García Cosmes, Maria Elena García López, Raquel García López, Belén Gómez Gómez, Maria Aurora Latorre Gálvez, Jose Luis Mijangos Rodriguez, Maria Luz Turégano Prieto

Abstract

Background: Physical activity may reverse frailty in the elderly, but we encounter barriers to the implementation of exercise programs in this population. Our main aim is to evaluate the effect of a multicomponent physical activity program, versus regular medical practice, on reverting pre-frailty status among the elderly, 12 months post-intervention.

Methods: Randomized parallel group multicenter clinical trial located in primary care setting, among non-dependent and pre-frail patients > 70 years old, including 190 patients (95 intervention, 95 control group).

Intervention: Multicomponent physical activity program (MEFAP, for its acronym in Spanish) with twelve 1.5 h-weekly sessions comprised of: 1. Informative session; 2. Exercises for improving aerobic resistance, muscle strength, propioception-balance and flexibility; and 3. Handing out of at-home exercise chart (twice/week). Main variable: pre-frailty according to the Fried phenotype. Secondary variables: sociodemographic, clinical and functional variables; exercise program adherence, patient satisfaction with the program and quality of life. We will perform an intention-to-treat analysis by comparing the retrogression from pre-frailty (1 or 2 Fried criteria) to robust status (0 Fried criteria) by the end of the intervention, 6 months and 12 months post-intervention. The accumulated incidence in each group will be calculated, as well as the relative risk (RR) and the number needed to treat (NNT) with their corresponding 95% confidence intervals. Protocol was approved by the Ethics Committee Hospital la Paz.

Discussion: Within the context of regular clinical practice, our results will provide evidence regarding the effects of exercise interventions on frailty among pre-frail older adults, a key population given their significant potential for functional, physical, and mental health improvement.

Trial registration: NCT03568084 . Registered 26 June 2018. Date of enrollment of the first participant to the trial: July 2nd 2018.

Keywords: Elderly; Exercise; Frailty; Physical activity; Primary health care; Randomised clinical trial.

Conflict of interest statement

Ethics approval and consent to participate

The trial respects the basic ethical principles of autonomy, beneficence, justice and doing no harm. Its implementation will follow the standards of Good Clinical Practice, the principles enunciated in the last Declaration of Helsinki (Fortaleza 2013), and the Oviedo Convention (1997).

Written informed consent will be obtained from all participants prior to inclusion in the study. All the objectives, physical tests, and aspects related to the methodology and the intervention will be explained orally and in writing. Researcher’s commitment will be requested from each participating professional. Data confidentiality and anonymity will be guaranteed in all phases of the study following the 2009 law regulating personal data protection.

The project has been approved by the Clinical Research Ethics Committee of the University Hospital La Paz in Madrid (HULP 5004) in March 2018.

The project has been registered in ClinicalTrial in 26 June 2018 (code: NCT03568084). The provided trial registration number is not retrospectively registered. The date of enrollment of the first participant to the trial was July 2nd 2018.

Consent for publication

Not applicable.

Competing interests

The authors declare that they no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
MEFAP Project Design. MEFAP: Multicomponent physical activity program (for its acronym in Spanish)

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