Status:
COMPLETED
Cognitive Frailty and Oxygen-ozone Therapy
Lead Sponsor:
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Conditions:
Cognitive Frailty
Eligibility:
All Genders
60-85 years
Phase:
NA
Brief Summary
As the world's population age, frailty is moving to the forefront of health and medical research and may become one of the world's most serious health issues. Understanding frailty prevention and trea...
Detailed Description
Background: Although frailty does not yet have an internationally recognized standard definition, the general premise is that it may be considered a geriatric syndrome reflecting multi-system dysfunct...
Eligibility Criteria
Inclusion
- subjects between the ages of 60 and 85, referring to the diagnosis of amnesic or non-amnesic cognitive disorder, reported by the subject himself or by family members;
- MMSE score \> 24/30;
- exclusion of dementia, even in the presence of ascertained Alzheimer's disease detected by the most advanced diagnostic techniques;
- function intact, or functional reduction not related to the cognitive problem;
- pharmacological therapy for the treatment of stable cognitive or behavioral disorders for at least 3 months at the time of enrolment;
- specific assessments/tools for frailty: "Italian frailty index (IFi)" and for "Frailty Instrument (FIt) based on the Survey of Health, Ageing and Retirement in Europe (SHARE-FIt)".
Exclusion
- subjects affected by disabling vision or hearing impairments;
- subjects affected by known psychosis or psychiatric illness, alcohol or drug abuse;
- subjects affected by uncontrolled hyperthyroidism or by Glucose-6-Phostate Dehydrogenase Deficiency (G6PD)-Favism (according to S.I.O.O.T Guidelines, http://www.ossiozono.it);
- subjects who considered invasive the methodology for rectal insufflation.
Key Trial Info
Start Date :
July 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 17 2023
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06071611
Start Date
July 2 2019
End Date
November 17 2023
Last Update
December 26 2023
Active Locations (1)
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1
IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli
Brescia, Italy, 25125