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Clinical Trials/NCT04962841
NCT04962841
Unknown
N/A

Cognitive and Physical Impairment in Frail Older Adults

University of Campania "Luigi Vanvitelli"1 site in 1 country485 target enrollmentApril 1, 2020
ConditionsFrailty

Overview

Phase
N/A
Intervention
Not specified
Conditions
Frailty
Sponsor
University of Campania "Luigi Vanvitelli"
Enrollment
485
Locations
1
Primary Endpoint
Montreal Cognitive Assessment (MoCA)
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2020
End Date
April 1, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Pasquale Mone

Principal Investigator

University of Campania "Luigi Vanvitelli"

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.

Outcomes

Primary Outcomes

Montreal Cognitive Assessment (MoCA)

Time Frame: July 2021

Global cognitive impairment

Secondary Outcomes

  • 5 metres gait speed test(July 2021)

Study Sites (1)

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