Actively Recruiting
RCT to Analyze the Efficacy of a Spanish Healthcare ministRy Based In InTervention to Reduce Frailty Status in Prefrail Older Adults
Led by Complejo Hospitalario Universitario de Albacete · Updated on 2025-03-18
273
Participants Needed
1
Research Sites
273 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
RCT to Analyze the Efficacy of a Spanish Healthcare ministRy Based In InTervention to Reduce Frailty Status in Prefrail Older Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Community-dwelling adults aged 70 years or older
- Barthel index greater than 85
- Gait speed less than 0.8 m/s OR prefrailty or frailty based on the frailty phenotype
- Ability to participate in the physical exercise program
- Ability to understand the trial procedures and interventions
- Ability to understand and sign informed consent
You will not qualify if you...
- Severe aortic valve stenosis or recent myocardial infarction within 6 weeks
- Recent venous thromboembolic disease within 6 weeks
- Inability to perform the physical tests required by the trial
- Inability to understand the trial procedures
- Active solid organ or blood cancer (except basal cell skin cancer) or life expectancy under one year
- Planned surgery that could interfere with the physical exercise program
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Complejo Hospitalario Universitario de Albacete
Albacete, Spain, 02006
Actively Recruiting
Research Team
P
Pedro Abizanda Soler, MD,PhD
CONTACT
A
Almudena Avendaño Céspedes, RN, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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