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

Abstract

BackgroundPhysical 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.MethodsRandomized 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.DiscussionWithin 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 registrationNCT03568084. Registered 26 June 2018. Date of enrollment of the first participant to the trial: July 2nd 2018.

“Camminando e Leggendo ... Ricordo” (Walking and Reading ... I Remember): Prevention of Frailty Through the Promotion of Physical Activity and Reading in People with Mild Cognitive Impairment. Results from the TREDEM Registry

“…Three of those six months were carried out at home and home activities were only self-reported. Other studies also evaluated the effectiveness of interventions to prevent frailty by proposing, at least in part, home-based physical activity without having objective control over the actual completion of the assigned exercises [64][65][66].…”

“…The engagement in physical and cognitive activities was objectively determined de visu by qualified trainers, rather than being self-reported by participants. Furthermore, unlike other studies such as the MEFAP project [66], an RCT which planned to use only physical activity aimed at pre-frail people, our study used both physical activity and reading proposing them to robust, pre-frail and frail participants. Finally, the present action plan received a prize as a "Quality project for the scientific methodology and accurate statistical evidence" assigned by the scientific committee of the "General State of Health Promotion in the province of Treviso" conference, held in Treviso in December 2019.…”

How to Improve the Functional Capacity of Frail and Pre-Frail Elderly People? Health, Nutritional Status and Exercise Intervention. The EXERNET-Elder 3.0 Project

“…Functional Period (Weeks [22][23][24] In this last period, a weekly session was dedicated to improving power and the other two to enhancing functional performance in DLA. Power sessions were composed of six to seven exercises involving lower and upper limbs separately or simultaneously, with two to three sets of 12-15 repetitions executed at high velocity.…”

“…Nevertheless, it is worth noting that frailty can be reversed through specific interventions, especially at early stages [20,21]. Considering the need to implement this kind of intervention prematurely, together with the aging of the world population [22,23], make the prevention, detection and treatment of frailty a major public health challenge [19,[23][24][25][26] not only to improve the quality of life of older adults but also to reduce care-related costs [27].…”

Clinical Practice Guidelines for Managing Frailty in Community-Dwelling Korean Elderly Adults in Primary Care Settings

“…12) In addition, positive results, such as improved physical function and quality of life, fall prevention, reduced emergency visits, and decline in healthcare costs have been reported with physical activity, polypharmacy, and nutritional interventions related to frailty. [13][14][15][16][17][18] As mentioned above, with the increase in the elderly population, healthy aging is gaining more and more emphasis and the management of frailty is increasing in importance. However, there are still no standardized clinical guidelines for the diagnosis and assessment of frailty and the implementation of appropriate interventions in Korea.…”