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VIVI-OLIVE: Multicomponent Exercise and Extra Virgin Olive Oil in Older Adults at High Risk of Falls

RecruitingNAAges 75 Years - anyAllFundacion Miguel Servet
NCT07829484 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

VIVI-OLIVE is a multicenter randomized clinical trial evaluating whether a 24-month intervention combining an individualized multicomponent exercise program (VIVIFRAIL), Mediterranean diet counselling, and supplementation with 60 mL/day of extra virgin olive oil (EVOO) can improve physical function and reduce fall risk in adults aged 75 years or older at high risk of falls. Participants will be randomly assigned to either the VIVI-OLIVE intervention or a control group following the VIVIFRAIL multicomponent exercise program. The main outcome is change in usual gait speed, which is an indicator of physical function and fall risk in older adults. Other outcomes include intrinsic capacity, functional independence, quality of life, muscle strength and sarcopenia, muscle characteristics, fear of falling, Mediterranean diet adherence, falls and fall-related consequences, and adherence to the s

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age 75 years or older. * Barthel Index \>60. * Independent ambulation, with or without an assistive device. * At least one frailty criterion according to the Fried frailty phenotype. * High risk of falls, defined by at least one of the following: gait speed \<0.8 m/s; two or more falls in the previous year; one fall requiring medical attention due to trauma; one fall associated with inability to rise independently or suspected syncope; or one fall in the previous year plus at least one frailty criterion. * Availability of a family member or caregiver to assist with the home exercise program. * Willingness to participate in the exercise and extra virgin olive oil supplementation protocol. Exclusion Criteria: * Acute myocardial infarction within the previous 3 months. * Unstable angina. * Uncontrolled cardiac arrhythmias. * Uncontrolled hypertension. * Recent pulmonary embolism. * Fracture within the previous 3 months. * Severe valvular heart disease. * Institutionalization or planned admission to a nursing home. * Inability to complete study follow-up. * Life expectancy of less than 3 months. * Major neurocognitive disorder (Reisberg Global Deterioration Scale ≥5). * Medical contraindication to exercise. * Habitual extra virgin olive oil consumption \>30 mL/day. * Intestinal malabsorption syndrome. * Allergy to nuts, fish, tomatoes, onions, or garlic.
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What it tests

  • VIVIFRAIL multicomponent exercise program
  • Mediterranean diet counselling
  • Extra virgin olive oil supplementation
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Where

1 site
Hospital Universitario de Navarra
Pamplona, 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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