title: Effectiveness of a multicomponent exercise program in the attenuation of frailty in long-term nursing home residents: study protocol for a randomized clinical controlled trial.
abstract: BACKGROUND
  There is increasing evidence suggesting that cognition and physical frailty interact within a cycle of decline associated with aging which has been called cognitive frailty. Exercise programs have demonstrated to be an effective tool to prevent functional and cognitive decline during aging, but little is known about their potential to restore or maintain functionality in individuals that require long-term nursing care. Besides, WHO has recently highlighted the importance of introducing systematic musculoskeletal health programs for older people living in residential care, as they represent a particularly vulnerable group for the development of noncommunicable diseases.
  
  
  METHODS
  This is a multicentre randomized controlled trial. 114 participants will be randomly allocated to a usual care group or to an intervention group. Inclusion criteria are as follows: ≥ 70 years, ≥ 50 on the Barthel Index, ≥ 20 on MEC-35 who are capable to stand up and walk independently for 10 m. Subjects in the intervention group will add to the activities scheduled for the control group the participation in a 6 months long multicomponent exercise program designed to improve strength, balance and walking retraining. Study assessments will be conducted at baseline and at 3 and 6 months. The primary outcome is change in function assessed by Short Physical Performance Battery and secondary outcomes include other measurements to assess all together the condition of frailty, which includes functionality, sedentary behaviors, cognitive and emotional status and biological markers. The present study has been approved by the Committee on Ethics in Research of the University of the Basque Country (Humans Committee Code M10/2016/105; Biological Samples Committee Code M30/2016/106).
  
  
  CONCLUSIONS
  Results from this research will show if ageing related functional and cognitive deterioration can be effectively prevented by physical exercise in institutionalized elders. It is expected that the results of this research will guide clinical practice in nursing home settings, so that clinicians and policymakers can provide more evidence-based practice for the management of institutionalized elder people.
  
  
  BACKGROUND
  The protocol has been registered under the Australian and New Zealand Clinical Trials Registry (ANZCTR) with the identifier: ACTRN12616001044415 .
authors.affiliation: Department of Physiology, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Barrio Sarriena s/n, E-48940, Leioa, Bizkaia, Spain. ana.rodriguez@ehu.eus.
authors.forename: Ana
authors.initials: A
authors.lastname: Rodriguez-Larrad
authors.affiliation: Department of Physiology, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Barrio Sarriena s/n, E-48940, Leioa, Bizkaia, Spain.
authors.forename: Haritz
authors.initials: H
authors.lastname: Arrieta
authors.affiliation: Department of Physiology, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Barrio Sarriena s/n, E-48940, Leioa, Bizkaia, Spain.
authors.forename: Chloe
authors.initials: C
authors.lastname: Rezola
authors.affiliation: Department of Nursing II, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), J. Begiristain Doktorearen pasealekua 105, E-20014, Donostia-San Sebastian, Gipuzkoa, Spain.
authors.forename: Maider
authors.initials: M
authors.lastname: Kortajarena
authors.affiliation: Matia Instituto Gerontológico, Camino de los Pinos 35, E-20018, Donostia-San Sebastian, Gipuzkoa, Spain.
authors.forename: Jose Javier
authors.initials: JJ
authors.lastname: Yanguas
authors.affiliation: Matia Instituto Gerontológico, Camino de los Pinos 35, E-20018, Donostia-San Sebastian, Gipuzkoa, Spain.
authors.forename: Miren
authors.initials: M
authors.lastname: Iturburu
authors.affiliation: Department of Physiology, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Barrio Sarriena s/n, E-48940, Leioa, Bizkaia, Spain.
authors.forename: María Gil
authors.initials: MG
authors.lastname: Susana
authors.affiliation: Department of Physiology, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Barrio Sarriena s/n, E-48940, Leioa, Bizkaia, Spain.
authors.forename: Jon
authors.initials: J
authors.lastname: Irazusta
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000375:Aging / Q000502:physiology / Q000523:psychology; D001315:Australia / Q000453:epidemiology; D015444:Exercise / Q000502:physiology / Q000523:psychology; D005081:Exercise Therapy / Q000379:methods* / Q000523:psychology / Q000639:trends; D005260:Female; D016330:Frail Elderly; D006707:Homes for the Aged / Q000639:trends; D006801:Humans; D008297:Male; D009520:New Zealand / Q000453:epidemiology; D009735:Nursing Homes / Q000639:trends; D055070:Resistance Training / Q000379:methods*; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome; D016138:Walking / Q000502:physiology / Q000523:psychology
keywords: Aging; Cognitive frailty; Exercise; Frailty; Nursing-home; Older adults; Physical activity