Synergy of Exercise and Nutrition in Preventing and Treating Frailty

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.

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Key information

Conditions

Frail Elderly Frailty Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Valencia /Hospital Clínico Universitario de València

Valencia, Spain, ES46010

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multidomain physical exercise

Other

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.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Other

Collaborators

Ministerio de Ciencia e Innovación, Spain
Nestle Health Science
University of Valencia

Registry information

Official study title

Study of the Synergy Between Physical Exercise and a Nutritional Supplement for the Prevention and Treatment of Frailty: The ROBUSTNES Study

Acronym: ROBUSTNES

Important dates

Study start: 2019
Primary completion: 2022
Study completion: 2022
First posted: May 16, 2025
Registry last updated: May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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