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

Sponsor: Fundacion Miguel Servet • ClinicalTrials.gov ID: NCT07829484

Registry updated: 2026-09-21

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Description

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 study interventions.

Interventions

VIVIFRAIL multicomponent exercise program (Behavioral)
Individualized multicomponent exercise program based on the VIVIFRAIL program, including strength, balance, gait, flexibility, and endurance exercises. The program is adapted to each participant's functional capacity and is performed throughout the 24-month intervention period.
Mediterranean diet counselling (Behavioral)
Participants receive individualized dietary counselling based on the Mediterranean diet, supported by nutritional recommendations and educational materials. Dietary adherence is reinforced during study visits throughout the 24-month intervention period.
Extra virgin olive oil supplementation (Dietary supplement)
Participants consume 60 mL/day of extra virgin olive oil (EVOO), equivalent to approximately four tablespoons per day, throughout the 24-month intervention period. EVOO is provided to participants as part of the VIVI-OLIVE intervention.

Eligibility criteria

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.

Conditions

Falls Frailty

Locations

Hospital Universitario de Navarra — Pamplona, Navarre, Spain

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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