CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 47 enrolled
Drug / intervention
Multidomain physical exerciseother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06975540
NCT06975540N/ACompleted

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

Fundación para la Investigación del Hospital Clínico de Valencia·interventional·Posted May 16, 2025·Updated May 16, 2025

In Brief

A clinical study evaluating Multidomain physical exercise for Frail Elderly. Completed, enrolled 47 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFrail Elderly
CountriesSpain

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMay 16, 2025
Enrollment StartOct 14, 2019
Primary CompletionJul 29, 2022
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 1.1 years ago

Interventions

Multidomain physical exerciseother

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.