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

2026年9月14日 更新者：Fundacion Miguel Servet

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

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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

VIVI-OLIVE is a multicenter, prospective, randomized, parallel-group clinical trial with a 24-month intervention and follow-up period. The study includes community-dwelling adults aged 75 years or older at high risk of falls.

Participants are randomly allocated in a 1:1 ratio to either the intervention group (VIVI-OLIVE) or the control group (VIVIFRAIL). Randomization is stratified by sex and study center using variable block sizes and is implemented through REDCap.

Participants allocated to the VIVI-OLIVE group follow an individualized VIVIFRAIL multicomponent exercise program, receive Mediterranean diet counselling, and consume 60 mL/day of extra virgin olive oil for 24 months. Participants allocated to the control group follow the individualized VIVIFRAIL multicomponent exercise program.

The primary objective is to evaluate the effectiveness of the VIVI-OLIVE intervention on fall risk and physical function, assessed through changes in usual gait speed. Secondary assessments include intrinsic capacity, functional independence, health-related quality of life, muscle strength and sarcopenia, muscle characteristics assessed by musculoskeletal ultrasound, fear of falling, adherence to the Mediterranean diet, falls and fall-related consequences, and adherence to the study interventions.

Participants undergo assessments from baseline through 24 months, with additional follow-up contacts between study visits to monitor falls and relevant clinical events.

研究类型

介入性

注册 (估计的)

140

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

75年 及以上 (年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：VIVI-OLIVE

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.
行为的：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.

行为的：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.

膳食补充剂：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.
有源比较器：VIVIFRAIL

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

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in usual gait speed
大体时间：Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months.

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.

次要结果测量

结果测量
措施说明
大体时间
Change in physical performance assessed by the Short Physical Performance Battery (SPPB)
大体时间：Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months.

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.
Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months.
Change in functional independence assessed by the Barthel Index
大体时间：Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.

Functional independence in activities of daily living will be assessed using the Barthel Index. Higher scores indicate greater independence in activities of daily living.
Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.
Change in health-related quality of life assessed by the EuroQol-5D
大体时间：Baseline, 6 months, 12 months, 18 months, and 24 months.

Health-related quality of life will be assessed using the Spanish version of the EuroQol-5D (EQ-5D).
Baseline, 6 months, 12 months, 18 months, and 24 months.
Change in handgrip strength
大体时间：From baseline to 24 months, according to the study assessment schedule.

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.
From baseline to 24 months, according to the study assessment schedule.
Change in sarcopenia status
大体时间：From baseline to 24 months, according to the study assessment schedule.

Sarcopenia status will be assessed using the SARC-F questionnaire, handgrip strength, and the five-repetition chair stand test, according to the study protocol.
From baseline to 24 months, according to the study assessment schedule.
Change in muscle thickness assessed by musculoskeletal ultrasound
大体时间：Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.

Muscle thickness of the rectus femoris and thenar eminence of the dominant hand will be assessed using musculoskeletal ultrasound. Change in muscle thickness from baseline will be evaluated over the 24-month follow-up.
Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.
Change in fear of falling
大体时间：From baseline to 24 months, according to the study assessment schedule.

Fear of falling will be assessed using the Short Falls Efficacy Scale-International (Short FES-I), with higher scores indicating greater concern about falling.
From baseline to 24 months, according to the study assessment schedule.
Change in adherence to the Mediterranean diet
大体时间：From baseline to 24 months, according to the study assessment schedule.

Adherence to the Mediterranean diet will be assessed using the 14-item Mediterranean Diet Adherence Screener (MEDAS-14). The total score ranges from 0 to 14 points, with higher scores indicating greater adherence to the Mediterranean diet.
From baseline to 24 months, according to the study assessment schedule.
Falls and fall-related consequences during follow-up
大体时间：Throughout the 24-month follow-up period.

Falls will be prospectively recorded using a falls diary and reviewed during follow-up contacts. The number of falls and fall-related consequences, including fractures and healthcare use, will be recorded.
Throughout the 24-month follow-up period.
Percentage adherence to the VIVIFRAIL exercise program
大体时间：Throughout the 24-month intervention period.

Adherence to the VIVIFRAIL multicomponent exercise program will be calculated as the percentage of prescribed exercise sessions completed by each participant: (number of exercise sessions completed / number of exercise sessions prescribed) × 100. Higher percentages indicate greater adherence.
Throughout the 24-month intervention period.
Change in cognitive performance assessed by the Montreal Cognitive Assessment (MoCA)
大体时间：Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.

Cognitive performance will be assessed using the Montreal Cognitive Assessment (MoCA). The total score ranges from 0 to 30 points, with higher scores indicating better cognitive performance.
Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.
Change in nutritional status assessed by the Mini Nutritional Assessment (MNA)
大体时间：Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.

Nutritional status will be assessed using the Mini Nutritional Assessment (MNA). The total score ranges from 0 to 14 points, with higher scores indicating better nutritional status. Scores of 12-14 indicate normal nutritional status, 8-11 indicate risk of malnutrition, and 0-7 indicate malnutrition.
Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.
Change in depressive symptoms assessed by the 15-item Geriatric Depression Scale (GDS-15)
大体时间：Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.

Depressive symptoms will be assessed using the 15-item Geriatric Depression Scale (GDS-15). The total score ranges from 0 to 15 points, with higher scores indicating greater depressive symptoms.
Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.
Number of participants with functional near vision assessed using a simple visual acuity test
大体时间：Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.

Near vision will be assessed at 3 meters using a simple visual acuity test and classified as functional or non-functional. The outcome will be reported as the number of participants classified as having functional near vision.
Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.
Number of participants with functional distance vision assessed using a simple visual acuity test
大体时间：Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.

Distance vision will be assessed at 6 meters using a simple visual acuity test and classified as functional or non-functional. The outcome will be reported as the number of participants classified as having functional distance vision.
Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.
Number of participants with functional hearing assessed using the whispered voice test
大体时间：Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.

Hearing will be assessed using the whispered voice test and classified according to the study protocol. The outcome will be reported as the number of participants with functional hearing.
Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.
Change in muscle cross-sectional area assessed by musculoskeletal ultrasound
大体时间：Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.

Muscle cross-sectional area of the rectus femoris and thenar eminence of the dominant hand will be assessed using musculoskeletal ultrasound. Change in muscle cross-sectional area from baseline will be evaluated over the 24-month follow-up.
Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.
Change in muscle echo intensity assessed by musculoskeletal ultrasound
大体时间：Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.

Muscle echo intensity of the rectus femoris and thenar eminence of the dominant hand will be assessed using musculoskeletal ultrasound as a measure of muscle quality. Change in muscle echo intensity from baseline will be evaluated over the 24-month follow-up.
Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.
Change in muscle ultrasound texture parameters
大体时间：Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.

Ultrasound image texture of the rectus femoris and thenar eminence of the dominant hand will be analyzed as a measure of muscle quality. Change in ultrasound texture parameters from baseline will be evaluated over the 24-month follow-up.
Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.
Percentage adherence to extra virgin olive oil supplementation
大体时间：Throughout the 24-month intervention period.

Adherence to extra virgin olive oil supplementation will be assessed in participants assigned to the VIVI-OLIVE intervention group using a daily adherence diary. Participants are prescribed 60 mL of extra virgin olive oil per day. Adherence will be calculated as the percentage of prescribed days on which the daily target of 60 mL is achieved.
Throughout the 24-month intervention period.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Fundacion Miguel Servet

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月10日

初级完成 (估计的)

2029年6月1日

研究完成 (估计的)

2029年6月1日

研究注册日期

首次提交

2026年9月4日

首先提交符合 QC 标准的

2026年9月14日

首次发布 (实际的)

2026年9月21日

研究记录更新

最后更新发布 (实际的)

2026年9月21日

上次提交的符合 QC 标准的更新

2026年9月14日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • ACH_VIVI-OLIVE

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

De-identified individual participant data underlying the results reported in study publications may be made available upon reasonable request to the corresponding author, subject to approval and compliance with applicable ethical and data protection requirements.

IPD 共享时间框架

Data may be available following publication of the study results. No predetermined end date for data availability has been established.

IPD 共享访问标准

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.

IPD 共享支持信息类型

  • 研究方案

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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