A randomized controlled trial protocol to test the efficacy of a dual-task multicomponent exercise program in the attenuation of frailty in long-term nursing home residents: Aging-ONDUAL-TASK study

Chloe Rezola-Pardo, Haritz Arrieta, Susana Maria Gil, Jose Javier Yanguas, Miren Iturburu, Jon Irazusta, Begoña Sanz, Ana Rodriguez-Larrad, Chloe Rezola-Pardo, Haritz Arrieta, Susana Maria Gil, Jose Javier Yanguas, Miren Iturburu, Jon Irazusta, Begoña Sanz, Ana Rodriguez-Larrad

Abstract

Background: The purpose of the Aging-ONDUAL-TASK study is to determine if a supervised dual-task program carried out in long-term nursing homes is able to attenuate frailty in a greater extent than the same multicomponent exercise program alone.

Methods: This multicenter randomized controlled trial will include 188 participants who will be randomly allocated to either a multicomponent exercise program or to the same multicomponent program with simultaneous cognitive training (dual-task training). Inclusion criteria are as follows: ≥ 70 years, ≥ 50 on the Barthel Index, ≥ 20 on the Mini Examen Cognoscitivo (MEC-35) who are able to stand up and walk independently for 10 m. Subjects in the multicomponent group will attend a twice-a-week multicomponent exercise program of 1-h duration per session, consisting of strength and balance exercises. Participants in the dual-task group will perform the same multicomponent exercise program with concurrent individually tailored cognitive tasks. Study assessments will be conducted at baseline and at 3 months. The primary outcome measure will be gait speed under dual-task conditions and secondary outcomes will include physical fitness measurements, gait spatiotemporal parameters, cognition and emotional assessments, several frailty scales and objectively measured physical activity.

Discussion: The present research will add valuable information to the knowledge around the effects of the dual-task program in long-term nursing home residents, taking altogether physical, cognitive and emotional variables linked to frailty.

Trial registration: Australian and New Zealand Clinical Trials Registry (ANZCTR) with the identifier: ACTRN12618000536268 . Registration date: 11/04/2018.

Keywords: Aging; Cognitive frailty; Dual-task; Dual-task intervention; Exercise; Frailty; Long-term nursing home; Older adults; Physical activity.

Conflict of interest statement

Ethics approval and consent to participate

The study has been approved by the Committee on Ethics in Research of the University of the Basque Country (Humans Committee Code M10/2016/105). All participants will provide written informed consent based on documents approved by the University of the Basque Country Institutional Review Board. In addition, the study will be conducted in accordance with Good Clinical Practice, applicable local regulatory requirements, and the guiding principles of the Declaration of Helsinki.

Consent for publication

‘Not applicable’.

Competing interests

The authors declare that they have 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
Flow diagram of the study

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