CompletedNot Applicable

Synergy of Exercise and Nutrition in Preventing and Treating Frailty

Spain47 participantsStarted 2019-10-14

Plain-language 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.

Who can participate

Age range70 Years

SexALL

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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.

What they're measuring

Frailty according to the Survey of Health, Ageing and Retirement in Europe Frailty Index (SHARE-FI)

Timeframe: 24 weeks (180 days)

Trial details

NCT IDNCT06975540

SponsorFundación para la Investigación del Hospital Clínico de Valencia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-29