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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: 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.

SUBMITTER: Castell MV

PROVIDER: S-EPMC6348680 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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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.

Castell M V MV Gutiérrez-Misis A A Sánchez-Martínez M M Prieto M A MA Moreno B B Nuñez S S Triano R R de Antonio M P MP Mateo C C Cano M D MD Garrido A A Julian R R Polentinos E E Rodriguez-Barrientos R R Otero Puime A A

BMC geriatrics 20190128 1

<h4>Background</h4>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.<h4>Methods</h4>Randomized parallel group multicenter clinical trial located in primary care setting, among non-dependent and pre-frail pati ...[more]

PMID: 30691405

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Project description:Frailty is a highly prevalent condition in old age leading to vulnerability and greater risk of adverse health outcomes and disability. Detecting and tackling frailty at an early stage can prevent disability. The purpose of this study is to evaluate the effectiveness of a multifactorial intervention program to modify frailty parameters, muscle strength, and physical and cognitive performance in people aged 65 years or more. It also assesses changes from baseline in falls, hospitalizations, nutritional risk, disability, institutionalization, and home-care.The current study is a randomised single-blind, parallel-group clinical trial, with a one and a half year follow-up, conducted in eight Primary Health Care Centres located in the city of Barcelona. Inclusion criteria are to be aged 65 years or older with positive frailty screening, timed get-up-and-go test between 10 to 30 seconds, and Cognition Mini-Exam (MEC-35) of Lobo greater than or equal to 18. A total of 352 patients have been equally divided into two groups: intervention and control. Sample size calculated to detect a 0.5 unit difference in the Short Physical Performance Battery (Common SD: 1.42, 20% lost to follow-up). In the intervention group three different actions on frailty dimensions: rehabilitative therapy plus intake of hyperproteic nutritional shakes, memory workshop, and medication review are applied to sets of 16 patients. Participants in both intervention and control groups receive recommendations on nutrition, healthy lifestyles, and home risks.Evaluations are blinded and conducted at 0, 3, and 18 months. Intention to treat analyses will be performed. Multivariate analysis will be carried out to assess time changes of dependent variables.It is expected that this study will provide evidence of the effectiveness of a multidisciplinary intervention on delaying the progression from frailty to disability in the elderly. It will help improve the individual's quality of life and also reduce the rates of falls, hospital admissions, and institutionalizations, thus making the health care system more efficient. This preventive intervention can be adapted to diverse settings and be routinely included in Primary Care Centres as a Preventive Health Programme.ClinicalTrials.gov PRS: NCT01969526. Date of registration: 10/21/2013.

Dataset Information

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.

Publications

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.

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