Objectives: The main objective is to analyze the efficacy of an intervention based on the algorithm proposed by the Spanish Healtcare Ministry (see figure in annex 1) at Primary Care level to reduce Frailty status or Physical Function in community-dwelling older adults. Secondary objectives are: 1. To analyze if the intervention is cost-effective; 2. To analyze if the intervention reduces hospitalizations and emergency department visits, incident disability, falls, institutionalization, mortality, Primary Care visits and Drug use, and improves quality of life.
Methodology: Multicentric Randomized Clinical Trial in 273 Prefrail or Frail or with a gait speed lower that 0.8 m/s community-dwelling women and men with an age equal or greater to 70 years, attended in selected Primary Care centers of Spain (Albacete, Hellín, Barcelona, Madrid, La Carlota, and Tacoronte). Randomization will be made by clusters, being every cluster a different Primary Care center in order to avoid contamination. Randomization on a 1:1 relationship between groups. The main outcome variable will be Frailty status or Physical function change (main composite outcome) at 8-month follow-up measured with the Frailty Phenotype and the Short Physical Performance Battery (SPPB) respectively. All instrumentation will follow the guidelines of the Spanish Healthcare Ministry algorithm for frailty updated 2022. Intervention will consist on a groupal multicomponent physical exercise program, a nutritional intervention program and a training in Frailty to Primary Care centers. The intervention will be delivered by trained experts in groups of 6 participants, and will be based on the recommendations of the Spanish Healthcare Ministry document, updated in 2022.
Community-dwelling adults with age equal or greater than 70 years.
Barthel index > 85
Gait speed < 0.8 m/s OR frailty /prefrailty using the frailty phenotype
Ability to realize the physical exercise program
Major contraindications for exercise: Severe aortic valve stenosis, myocardial infarction in the previous 6 weeks, Venous thromboembolic disease in the previous 6 weeks.
Inability to conduct the physical tests of the trial
Inability to understand the procedures of the trial
Active solid organ or hematologic neoplasm other than basocellular skin neoplasm, or life expectancy lower than one year.
Parallel
Multicomponent physical exercise program and a nutritional intervention
Other interventionThe exercise program will be delivered by trained experts in groups of 6 participants, and will be based on the recommendations presented in the Spanish Healthcare Ministry document. This program includes balance, flexibility, and strength and power exercises. The program will be realized twice a week, during 45 minutes time, for 16 weeks, twice a year. Nutritional intervention will be based on the results of MNA-SF. If the results of this instrument show normal nutrition status, general nutritional recommendations will de presented by a nutritionist twice a year before the physical exercise program. If MNA-SF shows nutritional risk or malnutrition, oral nutritional supplementation will be offered. Primary Care Physicians will have the opportunity of referring high risk participants to their Geriatrics Department Participants when appropriate, following Healthcare Ministry algorithm
Frailty status or Physical Function change (composite outcome)
Frailty will be determined with the Frailty Phenotype and Physical Function with the SPPB
Hospitalization
Number of hospitalizations during the follow-up for any cause.
Emergency department visits
Number of visits during the follow-up for any cause.
Mortality
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