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RCT to Analyze the Efficacy of a Spanish Healthcare ministRy Based In InTervention to Reduce Frailty Status in Prefrail Older Adults
Sponsor: Complejo Hospitalario Universitario de Albacete
Summary
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.
Official title: Multicenter Randomized Clinical Trial to Analyze the Efficacy of a Spanish Healthcare ministRy Based In InTervention to Reduce Frailty Status in Prefrail Older Adults (FRAILMERIT)
Key Details
Gender
All
Age Range
70 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
273
Start Date
2020-01-01
Completion Date
2025-03-31
Last Updated
2025-03-18
Healthy Volunteers
No
Interventions
Multicomponent physical exercise program and a nutritional intervention
The 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
Locations (1)
Complejo Hospitalario Universitario de Albacete
Albacete, Spain