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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

RecruitingNAAges 70 Years - 100 YearsAllComplejo Hospitalario Universitario de Albacete
NCT05002439 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 m

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 * Capacity to understand the procedures and interventions of the trial * Capacity to understand and sign the informed consent Exclusion Criteria: * 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. * Surgical intervention programmed that could interfere with the physical exercise program.
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What it tests

  • Multicomponent physical exercise program and a nutritional intervention
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Where

1 site
Complejo Hospitalario Universitario de Albacete
Albacete, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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