Clinical trial NCT04962841: Nutraceuticals and Drug Treatment in Frail Older Adults
Official title: Cognitive and Physical Impairment in Frail Older Adults
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Frailty
Keywords: frailty
cognitive impairment
physical impairment
older adults
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 485
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Frail older adults.

Brief summary: 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.

Detailed description: 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; hence, clinical evaluation is the main goal to get an early diagnosis and a timely treatment for cognitive impairment. Considering this background, the study will investigate the effects of nutraceuticals and drug treatment on cognitive impairment in frail older adults. In this scenario, global cognitive function will be evaluated with Mini Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA) test and physical impairment with the Fried criteria and 5-metres gait speed test.

Eligibility criteria: 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.

Primary outcomes:
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: July 2021
Secondary outcomes:
measure: 5 metres gait speed test
timeFrame: July 2021
Other outcomes:
measure: Correlation between MMSE/MoCA and 5 metres gait speed test
timeFrame: July 2021
Locations:
city: Naples
country: Italy
facility: Pasquale Mone
state: It
Study officials:
References:
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.
citation: 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.
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.
citation: Mone P, Pansini A, Jankauskas SS, Varzideh F, Kansakar U, Lombardi A, Trimarco V, Frullone S, Santulli G. L-Arginine Improves Cognitive Impairment in Hypertensive Frail Older Adults. Front Cardiovasc Med. 2022 Apr 12;9:868521. doi: 10.3389/fcvm.2022.868521. eCollection 2022.
citation: Mone P, Lombardi A, Gambardella J, Pansini A, Macina G, Morgante M, Frullone S, Santulli G. Empagliflozin Improves Cognitive Impairment in Frail Older Adults With Type 2 Diabetes and Heart Failure With Preserved Ejection Fraction. Diabetes Care. 2022 May 1;45(5):1247-1251. doi: 10.2337/dc21-2434.