Nutraceuticals and Drug Treatment in Frail Older Adults

May 4, 2022 updated by: Pasquale Mone, University of Campania "Luigi Vanvitelli"

Cognitive and Physical Impairment in Frail Older Adults

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

485

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Antonella Pansini, MD
  • Phone Number: 0823275386
  • Email: apansini@asl.it

Study Locations

  • Italy
    • It
      • Naples, It, Italy, 80138

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Frail older adults.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Frail older adults treated with nutraceuticals and drugs
Other: Nutraceuticals
To observe the effect on cognitive and physical impairment.
Other Names:
  • amlodipine
  • metformin
  • nebivolol
  • ramipril
  • sertraline
  • rivastigmine
  • empaglifozin
Frail older adults not treated with nutraceuticals and drugs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Montreal Cognitive Assessment (MoCA)
Time Frame: July 2021
Global cognitive impairment
July 2021

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5 metres gait speed test
Time Frame: July 2021
Physical impairment
July 2021

Other Outcome Measures

Outcome Measure
Time Frame
Correlation between MMSE/MoCA and 5 metres gait speed test
Time Frame: July 2021
July 2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campania "Luigi Vanvitelli"

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2020

Primary Completion (ACTUAL)

July 22, 2021

Study Completion (ANTICIPATED)

April 1, 2023

Study Registration Dates

First Submitted

July 10, 2021

First Submitted That Met QC Criteria

July 10, 2021

First Posted (ACTUAL)

July 15, 2021

Study Record Updates

Last Update Posted (ACTUAL)

May 10, 2022

Last Update Submitted That Met QC Criteria

May 4, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Campania Nord

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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