Frail ElderlyROBUSTNESNCT06975540
Synergy of Exercise and Nutrition in Preventing and Treating Frailty
A study testing Multidomain physical exercise in people with Frail Elderly, run by Fundación para la Investigación del Hospital Clínico de Valencia at 1 site in Spain.
Trial summary
The goal of this clinical study is to learn if combining a nutritional supplement with a multicomponent exercise program can help prevent and treat frailty in community dwelling older adults. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Frail Elderly
- What is being tested?
- Multidomain physical exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteSpain
- Study dates
- 14 Oct 2019to 29 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- i) men and women aged 70 years or older; ii) sedentary (less than three hours of weekly physical activity), iii) frail according to the Survey of Health, Ageing and Retirement in Europe Frailty Index (SHARE-FI); iv) gait speed lower or equal than 0.8 m/sec, v) community dwellers
Who cannot join
- i) life expectancy from the moment of selection lower than twelve months by any cause; ii) poorly controlled diabetes (glycated hemoglobin > 9%); iii) cognitive impairment (score less than 17 in the MMSE); iv) disability (score less than 50 points on Barthel's Scale); v) acute coronary event in the previous year; vi) hospital admission in the previous three months for any reason; vii) oncologic patient with active treatment with chemotherapy or radiotherapy; viii) major non-ambulatory surgery in the previous six months; ix) patient with a coronary event in the previous twelve months; x) institutionalized patient; xi) New York Heart Association class 3 to 4 baseline dyspnea; xii) lactose intolerance; xiii) being supplemented with a multivitamin or a protein-rich food; xiv) refusal to sign the informed consent.
Trial locations and contacts
1 site in 1 country.
Spain1 site
University of Valencia /Hospital Clínico Universitario de València
Valencia, Spain, ES46010
About this study
Official title: Study of the Synergy Between Physical Exercise and a Nutritional Supplement for the Prevention and Treatment of Frailty: The ROBUSTNES Study
The goal of this clinical study is to learn if combining a nutritional supplement with a multicomponent exercise program can help prevent and treat frailty in community dwelling older adults. The main questions it aims to answer is: Does combining a nutritional supplement (MERITENE) with a multicomponent exercise program improve frailty and functionality in older adults?
Researchers will compare:
Read more
- A group receiving both the nutritional supplement and the exercise program (intervention group)
- A control group receiving neither (control group)
Participants:
- take the nutritional supplement (MERITENE, 30g twice a day) for 180 days
- attend (3days/week) supervised exercise sessions as part of the multicomponent program for 180 days (if assigned to the intervention group).
- undergo regular clinical evaluations for frailty, nutritional status, cognitive function, emotional state, and quality of life.
Measurements will include: Changes in frailty status, particularly gait speed, measured using Share-fi criteria, nutritional assessment using the Mini Nutritional Assessment (MNA), physical and cognitive assessments, including Edmonton Frail Scale, MMSE, and Short Physical Performance Battery (SPPB) and a complete biochemical and clinical blood analysis.
- Conditions
- Frail Elderly
- Being tested
- Multidomain physical exercise
- Keywords
- Frailty, Malnutrition, Physical exercise program, Nutritional supplementation
- Medical subject headings
- Frailty, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidomain physical exerciseOther
The intervention includes a daily intake of two 200-mL of Meritene nutritional supplements (199 Kcal, 16g of protein, 25g of carbs, 3.6g of fats, and enriched with vitamins and minerals/bottle) plus a supervised and personalized multicomponent exercise program. Multicomponent exercise program (MEP) includes endurance, strength, coordination, balance, and flexibility exercises. The sessions last 65 min a day, 3 days/week for 24 weeks. All the sessions are supervised and delivered in groups by sports scientists.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants take the nutritional supplement (MERITENE, 30g twice a day) and attend supervised exercise sessions as part of the multicomponent program (3days/week) for 180 days. Receives: Other: Multidomain physical exercise |
| Control | No intervention | Participants receive neither. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frailty according to the Survey of Health, Ageing and Retirement in Europe Frailty Index (SHARE-FI)
Change in frailty status assessed by Fried's criteria after 180 days.
Measured: 24 weeks (180 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start14 Oct 2019
- Primary completion29 Jul 2022
- Study completion29 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Frail ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Valencia, Nestle Health Science, Ministerio de Ciencia e Innovación, Spain
- Responsible party
- Principal investigator, Maria Carmen Gómez Cabrera, Fundación para la Investigación del Hospital Clínico de Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06975540
- Sponsor's protocol ID
- MEJ-NES-2019
- Other IDs
- PID2019-110906RB-100, MEJ-NES-2019
- Acronym
- ROBUSTNES
- Status last verified
- May 2025
- First submitted
- 8 May 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Garcia-Gimenez JL, Mena-Molla S, Tarazona-Santabalbina FJ, Vina J, Gomez-Cabrera MC, Pallardo FV. Implementing Precision Medicine in Human Frailty through Epigenetic Biomarkers. Int J Environ Res Public Health. 2021 Feb 15;18(4):1883. doi: 10.3390/ijerph18041883.
PubMed 33672064Millan-Domingo F, Tarazona-Santabalbina FJ, Carretero A, Olaso-Gonzalez G, Vina J, Gomez-Cabrera MC. Real-Life Outcomes of a Multicomponent Exercise Intervention in Community-Dwelling Frail Older Adults and Its Association with Nutritional-Related Factors. Nutrients. 2022 Dec 3;14(23):5147. doi: 10.3390/nu14235147.
PubMed 36501177Arc-Chagnaud C, Millan F, Salvador-Pascual A, Correas AG, Olaso-Gonzalez G, De la Rosa A, Carretero A, Gomez-Cabrera MC, Vina J. Reversal of age-associated frailty by controlled physical exercise: The pre-clinical and clinical evidences. Sports Med Health Sci. 2019 Sep 10;1(1):33-39. doi: 10.1016/j.smhs.2019.08.007. eCollection 2019 Dec.
PubMed 35782461Olaso-Gonzalez G, Millan-Domingo F, Garcia-Fernandez L, Garcia-Tercero E, Cebrian M, Garcia-Dominguez C, Carbonell JA, Casabo-Valles G, Garcia-Gimenez JL, Tamayo-Torres E, Gambini J, Tarazona-Santabalbina FJ, Vina J, Gomez-Cabrera MC. A Multidomain Lifestyle Intervention Is Associated With Improved Functional Trajectories and Favorable Changes in Epigenetic Aging Markers in Frail Older Adults: A Randomized Controlled Trial. Aging Cell. 2026 Feb;25(2):e70376. doi: 10.1111/acel.70376.
PubMed 41677077
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Synergy Between Physical Exercise and a Nutritional Supplement for the Prevention and Treatment of Frailty: The ROBUSTNES Study
- ClinicalTrials.gov ID
- NCT06975540
- Acronym / sponsor ID
- ROBUSTNES / MEJ-NES-2019
- Conditions
- Frail Elderly
- Keywords
- Frailty, Malnutrition, Physical exercise program, Nutritional supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de ValenciaUniversity, hospital or other
- Collaborators
- University of Valencia, Nestle Health Science, Ministerio de Ciencia e Innovación, Spain
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 29 Jul 2022 (actual)
- Study completion
- 29 Jul 2022 (actual)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical study is to learn if combining a nutritional supplement with a multicomponent exercise program can help prevent and treat frailty in community dwelling older adults. The main questions it aims to answer is: Does combining a nutritional supplement (MERITENE) with a multicomponent exercise program improve frailty and functionality in older adults?
Researchers will compare:
- A group receiving both the nutritional supplement and the exercise program (intervention group)
- A control group receiving neither (control group)
Participants:
- take the nutritional supplement (MERITENE, 30g twice a day) for 180 days
- attend (3days/week) supervised exercise sessions as part of the multicomponent program for 180 days (if assigned to the intervention group).
- undergo regular clinical evaluations for frailty, nutritional status, cognitive function, emotional state, and quality of life.
Measurements will include: Changes in frailty status, particularly gait speed, measured using Share-fi criteria, nutritional assessment using the Mini Nutritional Assessment (MNA), physical and cognitive assessments, including Edmonton Frail Scale, MMSE, and Short Physical Performance Battery (SPPB) and a complete biochemical and clinical blood analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Multidomain physical exerciseParticipants take the nutritional supplement (MERITENE, 30g twice a day) and attend supervised exercise sessions as part of the multicomponent program (3days/week) for 180 days. |
| Control | No intervention | –Participants receive neither. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- i) men and women aged 70 years or older; ii) sedentary (less than three hours of weekly physical activity), iii) frail according to the Survey of Health, Ageing and Retirement in Europe Frailty Index (SHARE-FI); iv) gait speed lower or equal than 0.8 m/sec, v) community dwellers
Key exclusion criteria (1 listed)
- i) life expectancy from the moment of selection lower than twelve months by any cause; ii) poorly controlled diabetes (glycated hemoglobin > 9%); iii) cognitive impairment (score less than 17 in the MMSE); iv) disability (score less than 50 points on Barthel's Scale); v) acute coronary event in the previous year; vi) hospital admission in the previous three months for any reason; vii) oncologic patient with active treatment with chemotherapy or radiotherapy; viii) major non-ambulatory surgery in the previous six months; ix) patient with a coronary event in the previous twelve months; x) institutionalized patient; xi) New York Heart Association class 3 to 4 baseline dyspnea; xii) lactose intolerance; xiii) being supplemented with a multivitamin or a protein-rich food; xiv) refusal to sign the informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidomain physical exerciseThe intervention includes a daily intake of two 200-mL of Meritene nutritional supplements (199 Kcal, 16g of protein, 25g of carbs, 3.6g of fats, and enriched with vitamins and minerals/bottle) plus a supervised and personalized multicomponent exercise program. Multicomponent exercise program (MEP) includes endurance, strength, coordination, balance, and flexibility exercises. The sessions last 65 min a day, 3 days/week for 24 weeks. All the sessions are supervised and delivered in groups by sports scientists. | Other | Intervention |
Primary outcome
Frailty according to the Survey of Health, Ageing and Retirement in Europe Frailty Index (SHARE-FI)
Time frame: 24 weeks (180 days)
Change in frailty status assessed by Fried's criteria after 180 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Background: PubMed 33672064Garcia-Gimenez JL, Mena-Molla S, Tarazona-Santabalbina FJ, Vina J, Gomez-Cabrera MC, Pallardo FV. Implementing Precision Medicine in Human Frailty through Epigenetic Biomarkers. Int J Environ Res Public Health. 2021 Feb 15;18(4):1883. doi: 10.3390/ijerph18041883.
- Background: PubMed 36501177Millan-Domingo F, Tarazona-Santabalbina FJ, Carretero A, Olaso-Gonzalez G, Vina J, Gomez-Cabrera MC. Real-Life Outcomes of a Multicomponent Exercise Intervention in Community-Dwelling Frail Older Adults and Its Association with Nutritional-Related Factors. Nutrients. 2022 Dec 3;14(23):5147. doi: 10.3390/nu14235147.
- Background: PubMed 35782461Arc-Chagnaud C, Millan F, Salvador-Pascual A, Correas AG, Olaso-Gonzalez G, De la Rosa A, Carretero A, Gomez-Cabrera MC, Vina J. Reversal of age-associated frailty by controlled physical exercise: The pre-clinical and clinical evidences. Sports Med Health Sci. 2019 Sep 10;1(1):33-39. doi: 10.1016/j.smhs.2019.08.007. eCollection 2019 Dec.
- Derived from this study: PubMed 41677077Olaso-Gonzalez G, Millan-Domingo F, Garcia-Fernandez L, Garcia-Tercero E, Cebrian M, Garcia-Dominguez C, Carbonell JA, Casabo-Valles G, Garcia-Gimenez JL, Tamayo-Torres E, Gambini J, Tarazona-Santabalbina FJ, Vina J, Gomez-Cabrera MC. A Multidomain Lifestyle Intervention Is Associated With Improved Functional Trajectories and Favorable Changes in Epigenetic Aging Markers in Frail Older Adults: A Randomized Controlled Trial. Aging Cell. 2026 Feb;25(2):e70376. doi: 10.1111/acel.70376.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidomain physical exercise in people with Frail Elderly, run by Fundación para la Investigación del Hospital Clínico de Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frailty according to the Survey of Health, Ageing and Retirement in Europe Frailty Index (SHARE-FI) (time frame: 24 weeks (180 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06975540, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.