Clinical trial NCT06975540: Synergy of Exercise and Nutrition in Preventing and Treating Frailty
Official title: Study of the Synergy Between Physical Exercise and a Nutritional Supplement for the Prevention and Treatment of Frailty: The ROBUSTNES Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frail Elderly
Keywords: Frailty
Malnutrition
Physical exercise program
Nutritional supplementation
Lead sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
Sponsor class: OTHER
Collaborators: name: University of Valencia
name: Nestle Health Science
name: Ministerio de Ciencia e Innovación, Spain
First posted: 2025-05-16
Enrollment: 47
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Frailty according to the Survey of Health, Ageing and Retirement in Europe Frailty Index (SHARE-FI)
timeFrame: 24 weeks (180 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: University of Valencia /Hospital Clínico Universitario de València
Study officials:
References:
citation: 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.
citation: Millan-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.
citation: Arc-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.