An interventional study of VIVIFRAIL multicomponent exercise program and Mediterranean diet counselling in Falls and Frailty, sponsored by Fundacion Miguel Servet. Recruiting at 1 site in Spain. Open to participants aged 75 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Fundacion Miguel Servet · Not applicable, Interventional, and Prevention
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.
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.
1,284 studies on the registry are indexed under Frailty; 452 are open to participants now.
This study's planned enrollment of 140 is above the median of 81 across 767 interventional studies indexed under Frailty.
Browse Frailty studies →Fundacion Miguel Servet is the lead sponsor of 48 studies on the registry; 21 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: VIVIFRAIL multicomponent exercise program · Behavioral: Mediterranean diet counselling · Dietary Supplement: Extra virgin olive oil supplementation
Participants follow an individualized VIVIFRAIL multicomponent exercise program for 24 months.
Behavioral: 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.
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.
Change in usual gait speed
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.
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months.
Change in physical performance assessed by the Short Physical Performance Battery (SPPB)
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.
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months.
Change in functional independence assessed by the Barthel Index
Functional independence in activities of daily living will be assessed using the Barthel Index. Higher scores indicate greater independence in activities of daily living.
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.
Change in health-related quality of life assessed by the EuroQol-5D
Health-related quality of life will be assessed using the Spanish version of the EuroQol-5D (EQ-5D).
Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months.
Change in handgrip strength
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.
Time frame: From baseline to 24 months, according to the study assessment schedule.
Change in sarcopenia status
Sarcopenia status will be assessed using the SARC-F questionnaire, handgrip strength, and the five-repetition chair stand test, according to the study protocol.
Time frame: From baseline to 24 months, according to the study assessment schedule.
Change in muscle thickness assessed by musculoskeletal ultrasound
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.
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.
Change in fear of falling
Fear of falling will be assessed using the Short Falls Efficacy Scale-International (Short FES-I), with higher scores indicating greater concern about falling.
Time frame: From baseline to 24 months, according to the study assessment schedule.
Change in adherence to the Mediterranean diet
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.
Time frame: From baseline to 24 months, according to the study assessment schedule.
Falls and fall-related consequences during follow-up
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.
Time frame: Throughout the 24-month follow-up period.
Percentage adherence to the VIVIFRAIL exercise program
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.
Time frame: Throughout the 24-month intervention period.
Change in cognitive performance assessed by the Montreal Cognitive Assessment (MoCA)
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.
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.
Change in nutritional status assessed by the Mini Nutritional Assessment (MNA)
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.
Time frame: 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)
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.
Number of participants with functional hearing assessed using the whispered voice test
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.
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.
Change in muscle cross-sectional area assessed by musculoskeletal ultrasound
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.
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.
Change in muscle echo intensity assessed by musculoskeletal ultrasound
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.
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.
Change in muscle ultrasound texture parameters
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.
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.
Percentage adherence to extra virgin olive oil supplementation
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.
Time frame: Throughout the 24-month intervention period.
Plan to share: Yes — 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.
Supporting information: Study protocol
Time frame: Data may be available following publication of the study results. No predetermined end date for data availability has been established.
Access criteria: 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.
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Jun 2029, 36 months after the start.
Of 513 non-industry interventional studies with no phase under Frailty, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 39. This study's planned 36 months is above that.
Counting every sponsor, half of 517 studies reached it within 22 months; a quarter within 10 and three quarters within 39.
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Fundacion Miguel Servet