Status:
COMPLETED
Synergy of Exercise and Nutrition in Preventing and Treating Frailty
Lead Sponsor:
Fundación para la Investigación del Hospital Clínico de Valencia
Collaborating Sponsors:
University of Valencia
Nestle Health Science
Conditions:
Frail Elderly
Eligibility:
All Genders
70+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 29 2022
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT06975540
Start Date
October 14 2019
End Date
July 29 2022
Last Update
May 16 2025
Active Locations (1)
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1
University of Valencia /Hospital Clínico Universitario de València
Valencia, Spain, Spain, ES46010