Nutraceuticals and Drug Treatment in Frail Older Adults

• Conditions: Frailty
• Interventions: Other: Nutraceuticals

• Registration Number: NCT04962841
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

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.

Study Timeline

• Study Start: 2020-04-01
• Study First Submitted: 2021-07-10
• Study First Submitted QC: 2021-07-10
• Study First Posted: 2021-07-15
• Primary Completion: 2021-07-22
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-04
• Last Update Posted: 2022-05-10
• Study Completion: 2023-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 485

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Frail older adults treated with nutraceuticals and drugs	Nutraceuticals	-

Primary Outcome Measures

Name	Time	Method
Montreal Cognitive Assessment (MoCA)	July 2021	Global cognitive impairment

Secondary Outcome Measures

Name	Time	Method
5 metres gait speed test	July 2021	Physical impairment

Trial Locations

Locations (1)

Pasquale Mone; 🇮🇹 Naples, It, Italy