Nutraceuticals and Drug Treatment in Frail Older Adults

University of Campania "Luigi Vanvitelli"

Status: Unknown

Conditions: Frailty

Treatments: Other: Nutraceuticals

Study type: Observational

Funder types: Other

Identifiers

NCT04962841

Campania Nord

Details and patient eligibility

About

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.

Full 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.

Enrollment: 485 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

485 participants in 2 patient groups

Frail older adults treated with nutraceuticals and drugs

Treatment:

Other: Nutraceuticals

Frail older adults not treated with nutraceuticals and drugs