VIVI-OLIVE: Multicomponent Exercise and Extra Virgin Olive Oil in Older Adults at High Risk of Falls (VIVI-OLIVE)
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.
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Navarre
-
Pamplona, Navarre, Španělsko
- Nábor
- Hospital Universitario de Navarra
-
Kontakt:
- Álvaro Casas Herrero
- Telefonní číslo: +34 606299823
- E-mail: alvaro.casas.herrero@navarra.es
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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. |
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. 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. 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. |
|
Aktivní komparátor: VIVIFRAIL
Participants follow an individualized VIVIFRAIL multicomponent exercise program for 24 months. |
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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in usual gait speed
Časové okno: 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.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in physical performance assessed by the Short Physical Performance Battery (SPPB)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- ACH_VIVI-OLIVE
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
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.
Časový rámec sdílení IPD
Data may be available following publication of the study results. No predetermined end date for data availability has been established.
Kritéria přístupu pro sdílení IPD
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.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .