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

Study acronym: VIVI-OLIVE
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07829484
Lead Sponsor Fundacion Miguel Servet
Conditions Falls, Frailty
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov