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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Change in usual gait speed
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 75 years or older.
- •Barthel Index >
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: VIVIFRAIL multicomponent exercise program (Behavioral)
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.
干预措施: Mediterranean diet counselling (Behavioral)
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.
干预措施: Extra virgin olive oil supplementation (Dietary Supplement)
VIVIFRAIL
Participants follow an individualized VIVIFRAIL multicomponent exercise program for 24 months.
干预措施: VIVIFRAIL multicomponent exercise program (Behavioral)
结局指标
主要结局
Change in usual gait speed
时间窗: 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.
次要结局
- 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.)
- Change in muscle thickness assessed by musculoskeletal ultrasound(Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.)
- Change in fear of falling(From baseline to 24 months, according to the study assessment schedule.)
- Change in adherence to the Mediterranean diet(From baseline to 24 months, according to the study assessment schedule.)
- Falls and fall-related consequences during follow-up(Throughout the 24-month follow-up period.)
- Percentage adherence to the VIVIFRAIL exercise program(Throughout the 24-month intervention period.)
- Change in cognitive performance assessed by the Montreal Cognitive Assessment (MoCA)(Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.)
- Change in nutritional status assessed by the Mini Nutritional Assessment (MNA)(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)(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(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(Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.)
- Number of participants with functional hearing assessed using the whispered voice test(Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.)
- Change in muscle cross-sectional area assessed by musculoskeletal ultrasound(Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.)
- Change in muscle echo intensity assessed by musculoskeletal ultrasound(Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.)
- Change in muscle ultrasound texture parameters(Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.)
- Percentage adherence to extra virgin olive oil supplementation(Throughout the 24-month intervention period.)