Intervention to reduce frailty in older adults in Spain
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)
This study is testing a new exercise and nutrition program to see if it can help older adults in Spain feel stronger and healthier.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 273 (estimated) |
| Ages | 70 Years to 100 Years |
| Sex | All |
| Sponsor | Complejo Hospitalario Universitario de Albacete Academic / other |
| Locations | 1 site (Albacete) |
| Trial ID | NCT05002439 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a healthcare intervention designed by the Spanish Ministry of Health to reduce frailty and improve physical function in community-dwelling older adults aged 70 and above. The study will involve a multicentric randomized design, enrolling 273 participants from various primary care centers across Spain. Participants will undergo a multicomponent physical exercise program combined with nutritional support, with outcomes measured in terms of frailty status, hospitalizations, quality of life, and other health metrics.
Who should consider this trial
Good fit: Ideal candidates are community-dwelling adults aged 70 or older who are prefrail or frail, with a gait speed of less than 0.8 m/s.
Not a fit: Patients with major contraindications for exercise or severe health conditions that limit their ability to participate will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance the physical health and quality of life for older adults at risk of frailty.
How similar studies have performed: Other studies have shown promising results with similar multimodal interventions aimed at reducing frailty in older populations.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Albacete
- Complejo Hospitalario Universitario de Albacete — Albacete, Spain (Recruiting)
Study contacts
- Study coordinator: Pedro Abizanda Soler, MD,PhD
- Email: pabizanda@sescam.jccm.es
- Phone: +34636557437
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.