Synergy of Exercise and Nutrition in Preventing and Treating Frailty (ROBUSTNES)

Fundación para la Investigación del Hospital Clínico de Valencia

Status: Completed

Conditions: Frail Elderly

Treatments: Other: Multidomain physical exercise

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06975540

MEJ-NES-2019 (Other Grant/Funding Number)

PID2019-110906RB-100 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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47 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Other: Multidomain physical exercise

Control

No Intervention group

Description:

Participants receive neither.