About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Acute myocardial infarction within the previous 3 months.
Unstable angina.
Uncontrolled cardiac arrhythmias.
Uncontrolled hypertension.
Trial design
Parallel
Treatments tested in this trial
VIVIFRAIL multicomponent exercise program
BehavioralIndividualized 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
BehavioralParticipants 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 supplementParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
Change in usual gait speed
Change in usual gait speed assessed using the 5-meter gait speed test. Gait speed will be expressed in meters per second (m/s), with lower values indicating poorer physical performance and a higher risk of falls.
Secondary outcomes
Change in physical performance assessed by the Short Physical Performance Battery (SPPB)
Physical performance will be assessed using the Short Physical Performance Battery (SPPB). The total score ranges from 0 to 12 points, with higher scores indicating better physical performance.
Change in functional independence assessed by the Barthel Index
Functional independence in activities of daily living will be assessed using the Barthel Index. Higher scores indicate greater independence in activities of daily living.
Change in health-related quality of life assessed by the EuroQol-5D
Health-related quality of life will be assessed using the Spanish version of the EuroQol-5D (EQ-5D).
Change in handgrip strength
Handgrip strength will be assessed bilaterally using a handheld dynamometer. Two measurements will be performed for each hand and the mean value will be recorded. Handgrip strength will be expressed in kilograms (kg), with higher values indicating greater muscle strength.
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