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

NCT07829484 | Recruiting

• 1 other identifier: ACH_VIVI-OLIVE
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Falls; Frailty

Keywords

Older adults; High Risk of Falls; Multicomponent Exercise; VIVIFRAIL; Mediterranean Diet; Extra Virgin Olive Oil; Gait Speed; Intrinsic Capacity

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months.

Secondary Outcomes (20)

• Change in physical performance assessed by the Short Physical Performance Battery (SPPB)

  Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months.

• Change in functional independence assessed by the Barthel Index

  Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.

• Change in health-related quality of life assessed by the EuroQol-5D

  Baseline, 6 months, 12 months, 18 months, and 24 months.

• Change in handgrip strength

  From baseline to 24 months, according to the study assessment schedule.

• Change in sarcopenia status

  From baseline to 24 months, according to the study assessment schedule.

Study Arms (2)

VIVI-OLIVE

EXPERIMENTAL

Participants receive an individualized VIVIFRAIL multicomponent exercise program, Mediterranean diet counselling, and supplementation with 60 mL/day of extra virgin olive oil (EVOO) for 24 months.

Behavioral: VIVIFRAIL multicomponent exercise program; Behavioral: Mediterranean diet counselling; Dietary Supplement: Extra virgin olive oil supplementation

VIVIFRAIL

ACTIVE COMPARATOR

Participants follow an individualized VIVIFRAIL multicomponent exercise program for 24 months.

Behavioral: VIVIFRAIL multicomponent exercise program

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.

VIVI-OLIVE; VIVIFRAIL

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.

VIVI-OLIVE

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.

VIVI-OLIVE

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion Miguel Servet: lead

Study Sites (1)

Hospital Universitario de Navarra

Pamplona, Navarre, Spain

RECRUITING

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 21, 2026
• Study Start: June 10, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: September 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data may be available following publication of the study results. No predetermined end date for data availability has been established.
• Access Criteria: Researchers may request access to de-identified individual participant data from the corresponding author. Requests will be evaluated on a case-by-case basis and access will be subject to the purpose of the request, applicable ethical requirements, participant confidentiality, and data protection regulations.

Locations

ES (1)