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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized trial compares the VIVI-OLIVE intervention to a control that follows the VIVIFRAIL exercise program alone. Participants receive an individualized multicomponent exercise plan, Mediterranean diet counseling, and olive oil supplementation for 24 months, with the main outcome being change in usual gait speed. Secondary outcomes include measures of intrinsic capacity, independence, quality of life, muscle strength and sarcopenia, ultrasound-based muscle characteristics, fear of falling, diet adherence, falls and related consequences, and intervention adherence. Assessments occur from baseline through 24 months, with ongoing contact to monitor falls and clinical events. The study aims to determine if adding diet and olive oil to exercise offers added benefits in physical function and fall risk reduction.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Universitario de Navarra
  Pamplona, Navarre, Spain Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.