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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
Summary
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.
Official title: Effectiveness of a Combined Physical Exercise and Olive Oil Supplementation Intervention (VIVI-OLIVE) on Fall Risk in Frail Community-Dwelling Patients at High Risk of Falls: A Multicenter Randomized Clinical Trial
Key Details
Gender
All
Age Range
75 Years - Any
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2026-06-10
Completion Date
2029-06
Last Updated
2026-09-21
Healthy Volunteers
No
Interventions
VIVIFRAIL multicomponent exercise program
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
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
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.
Locations (1)
Hospital Universitario de Navarra
Pamplona, Navarre, Spain