RCT to Analyze the Efficacy of a Spanish Healthcare ministRy Based In InTervention to Reduce Frailty Status in Prefrail Older Adults

Recruiting now · Not applicable

Conditions studied: Frailty, Aged, Exercise

In brief

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.

Key facts

Study ID: NCT05002439
Run by: Complejo Hospitalario Universitario de Albacete
People needed: 273
Starts: 2020-01-01
Expected to finish: 2025-03-31
Last updated by the study team: 2025-03-18

Who can join

Age: 70 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

Complejo Hospitalario Universitario de Albacete — Albacete, Spain (enrolling)

Full record on ClinicalTrials.gov

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