NCT05002439 RCT to Analyze the Efficacy of a Spanish Healthcare ministRy Based In InTervention to Reduce Frailty Status in Prefrail Older Adults
| NCT ID | NCT05002439 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Complejo Hospitalario Universitario de Albacete |
| Condition | Frailty |
| Study Type | INTERVENTIONAL |
| Enrollment | 273 participants |
| Start Date | 2020-01-01 |
| Primary Completion | 2025-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 273 participants in total. It began in 2020-01-01 with a primary completion date of 2025-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05002439 clinical trial?
This trial is open to participants of all sexes, aged 70 Years or older, up to 100 Years, studying Frailty. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05002439 currently recruiting?
Yes, NCT05002439 is actively recruiting participants. Contact the research team at pabizanda@sescam.jccm.es for enrollment information.
Where is the NCT05002439 trial being conducted?
This trial is being conducted at Albacete, Spain.
Who is sponsoring the NCT05002439 clinical trial?
NCT05002439 is sponsored by Complejo Hospitalario Universitario de Albacete. The trial plans to enroll 273 participants.