Synergy of Exercise and Nutrition in Preventing and Treating Frailty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-14

Study Completion Date

2022-07-29

Brief Summary

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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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Detailed Description

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Conditions

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Frail Elderly

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Intervention

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.

Group Type EXPERIMENTAL

Multidomain physical exercise

Intervention Type 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.

Control

Participants receive neither.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Multidomain physical exercise

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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No