Ignite Creation Date:
2024-05-06 @ 3:28 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04648670
Status:
COMPLETED
Last Update Posted:
2020-12-03
First Post:
2020-11-23
Brief Title:
Cognitive Stimulation Program in Elderly
Sponsor:
Universidad de Zaragoza
Organization:
Universidad de Zaragoza
Study Overview
Official Title:
Cognitive Stimulation Program in Elderly With Normal Cognition a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The participants who carry out our cognitive stimulation program maintain and or improve their score of the 35-point Spanish version of 35 points of Mini-mental State of Folstein Mini-exam Cognoscitive of Lobo
Detailed Description:
The aim of our research is to evaluate the effect of a cognitive stimulation program in older adults aged 65 or over The intervention was carried out at the Foundation of Zaragoza Spain consisting of 10 sessions of 45 minutesweek during 10 weekswith normal cognition and compare it in the short medium and long term with the evolution of other people with the same characteristics and for which this intervention has not been carried out
The significant increase in the number of people over 65 years of age in relation to the total population suggests a significant increase in age-related pathologies Prevention is essential to avoid cognitive aging and preserve higher mental functions
From an economic perspective it is estimated that people with mild cognitive impairment produce 16 more spending than those with normal cognition
Cognitive stimulation is a low-cost non-pharmacological treatment that has shown its benefits in the preservation of cognitive aspects based on the brain plasticity it generates
Our research is based on cognitive stimulation using the yellow and Orange Mental Activation notebooks levels that correspond to the scores of Lobos cognitive Mini-test The book consists of 4 practical exercises that work on 10 cognitive aspects memory orientation language praxis gnosis calculation perception reasoning attention and programming in total 40 exercises The models on which the laptop is based are the cognitive model and the human occupation model
In the Health Center San José Norte-Centro of Zaragoza Spain assessments were made to 416 volunteer candidates of which 215 were excluded for not meeting the inclusion criteria being a total of 201participants that have been part of the randomized controlled trial Of the 201 participants 101 have carried out the intervention as an intervention group and 100 as the control group The control group did not perform any type of intervention
The intervention was carried out at the Foundation of Zaragoza Spain consisting of 10 sessions of 45 minutesweek during 10 weeks
The conceptual framework of this intervention is formed by the framework for practice of Occupational Therapy the cognitive model and the human occupation model of Gary Kielhofner
To homogenize both the assessments and the intervention a standardized training was carried out for the occupational therapists who carried them out and consisted of a theoretical part and a practical part of 10 hours each
The study began in December 2011 obtained the authorization of the Directorate of Primary Care of the Zaragoza II Sector and the approval of the project by the Research Ethics Committee of the Government of Aragón CEICA This study has followed the ethical standards recognized by the Declaration of Helsinki The initial assessments began this month The necessary sample size was reached in October 2012 and from that moment on randomization and intervention with the selected participants was carried out Three other assessments were made both for the intervention group and for the control group immediately after the intervention six months and one year after the intervention
The significant increase in the number of people over 65 years of age in relation to the total population suggests a significant increase in age-related pathologies Prevention is essential to avoid cognitive aging and preserve higher mental functions
From an economic perspective it is estimated that people with mild cognitive impairment produce 16 more spending than those with normal cognition
Cognitive stimulation is a low-cost non-pharmacological treatment that has shown its benefits in the preservation of cognitive aspects based on the brain plasticity it generates
Our research is based on cognitive stimulation using the yellow and Orange Mental Activation notebooks levels that correspond to the scores of Lobos cognitive Mini-test The book consists of 4 practical exercises that work on 10 cognitive aspects memory orientation language praxis gnosis calculation perception reasoning attention and programming in total 40 exercises The models on which the laptop is based are the cognitive model and the human occupation model
In the Health Center San José Norte-Centro of Zaragoza Spain assessments were made to 416 volunteer candidates of which 215 were excluded for not meeting the inclusion criteria being a total of 201participants that have been part of the randomized controlled trial Of the 201 participants 101 have carried out the intervention as an intervention group and 100 as the control group The control group did not perform any type of intervention
The intervention was carried out at the Foundation of Zaragoza Spain consisting of 10 sessions of 45 minutesweek during 10 weeks
The conceptual framework of this intervention is formed by the framework for practice of Occupational Therapy the cognitive model and the human occupation model of Gary Kielhofner
To homogenize both the assessments and the intervention a standardized training was carried out for the occupational therapists who carried them out and consisted of a theoretical part and a practical part of 10 hours each
The study began in December 2011 obtained the authorization of the Directorate of Primary Care of the Zaragoza II Sector and the approval of the project by the Research Ethics Committee of the Government of Aragón CEICA This study has followed the ethical standards recognized by the Declaration of Helsinki The initial assessments began this month The necessary sample size was reached in October 2012 and from that moment on randomization and intervention with the selected participants was carried out Three other assessments were made both for the intervention group and for the control group immediately after the intervention six months and one year after the intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None