Synergy of Exercise and Nutrition in Preventing and Treating Frailty

Not Applicable

Completed

• Conditions: Frail Elderly

• Registration Number: NCT06975540
• Lead Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-14
• Primary Completion: 2022-07-29
• Study Completion: 2022-07-29
• Status Verified: 2025-05
• Study First Submitted: 2025-05-08
• Study First Submitted QC: 2025-05-08
• Last Update Submitted: 2025-05-08
• Study First Posted: 2025-05-16
• Last Update Posted: 2025-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Frailty according to the Survey of Health, Ageing and Retirement in Europe Frailty Index (SHARE-FI)	24 weeks (180 days)	Change in frailty status assessed by Fried's criteria after 180 days.

Trial Locations

Locations (1)

University of Valencia /Hospital Clínico Universitario de València; 🇪🇸 Valencia, Spain