Frailty Clinical Trial
Official title:
Cognitive and Physical Impairment in Frail Older Adults
NCT number | NCT04962841 |
Other study ID # | Campania Nord |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 1, 2020 |
Est. completion date | April 1, 2023 |
Frailty is a multidimensional condition due to reserve loss leading to physical and cognitive impairment that is very common in older adults; in fact, its incidence increases with age. Frail older adults present a high risk of adverse events such as disability, hospitalization and mortality. It is very important to check comorbidities and complications to reduce the incidence of cognitive and physical impairment.
Status | Recruiting |
Enrollment | 485 |
Est. completion date | April 1, 2023 |
Est. primary completion date | July 22, 2021 |
Accepts healthy volunteers | |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: - age > 65 years; - a frailty status. Exclusion Criteria: - age < 65 years. - no frailty status. - left ventricular ejection fraction <25%, with previous myocardial infarction or previous PPCI or/and coronary by-pass grafting. |
Country | Name | City | State |
---|---|---|---|
Italy | Pasquale Mone | Naples | It |
Lead Sponsor | Collaborator |
---|---|
University of Campania "Luigi Vanvitelli" |
Italy,
Afilalo J, Alexander KP, Mack MJ, Maurer MS, Green P, Allen LA, Popma JJ, Ferrucci L, Forman DE. Frailty assessment in the cardiovascular care of older adults. J Am Coll Cardiol. 2014 Mar 4;63(8):747-62. doi: 10.1016/j.jacc.2013.09.070. Epub 2013 Nov 27. Review. — View Citation
Cortes-Canteli M, Iadecola C. Alzheimer's Disease and Vascular Aging: JACC Focus Seminar. J Am Coll Cardiol. 2020 Mar 3;75(8):942-951. doi: 10.1016/j.jacc.2019.10.062. Review. — View Citation
Jung HW, Baek JY, Jang IY, Guralnik JM, Rockwood K, Lee E, Kim DH. Short Physical Performance Battery as a Crosswalk Between Frailty Phenotype and Deficit Accumulation Frailty Index. J Gerontol A Biol Sci Med Sci. 2021 Nov 15;76(12):2249-2255. doi: 10.1093/gerona/glab087. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Correlation between MMSE/MoCA and 5 metres gait speed test | July 2021 | ||
Primary | Montreal Cognitive Assessment (MoCA) | Global cognitive impairment | July 2021 | |
Secondary | 5 metres gait speed test | Physical impairment | July 2021 |
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