The Benefits of the Use of the Feuerstein Cognitive Training Method on Cognitive Function in Community-dwelling Older Patients With Mild Cognitive Impairment: a Pilot Study
Primary Purpose
Mild Cognitive Impairment
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Feuerstein Program
Sponsored by

About this trial
This is an interventional supportive care trial for Mild Cognitive Impairment focused on measuring Mild Cognitive Impairment
Eligibility Criteria
Inclusion Criteria:
- Age 65 years and older
- Able to read and speak Hebrew
- Provide informed consent for participation in the study
- Clinical diagnosis of MCI based on Consensus Criteria
- A score of lower than 95 on the Memory Index of the Mindstreams Mild Cognitive Impairment Computerized Assessment Battery
Exclusion Criteria:
- A medical condition (such as advanced heart failure, unstable ischemic heart disease, a lung condition with dyspnea on mild effort, intractable pain) or functional impairment (especially limiting mobility without the home) that does not allow the subject to participate in the training activities for the full duration of the study
- A diagnosis of depression, bipolar disorder or schizophrenia
- A cognitive diagnosis other than MCI, such as delirium, dementia or mental retardation
- Visual impairment not corrected by the use of spectacles
- Hearing impairment not corrected by hearing aids
Sites / Locations
- Yan Press
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Feuerstein Program
Arm Description
15 subjects conforming to inclusion and exclusion criteria with a known clinical diagnosis of MCI and who provide informed consent will undergo cognitive and functional assessment to confirm the diagnosis of MCI. Baseline assessment using the Mindstreams Mild Cognitive Impairment Computerized Assessment Battery will be performed. Subjects will then participate 30 twice weekly meetings of 90 minutes duration each (for a total of 15 weeks). Mindstreams testing will be repeated after 15 sessions and at completion of the study.
Outcomes
Primary Outcome Measures
Mindstreams Mild Cognitive Impairment Computerized Assessment Battery
The Mindstreams Mild Cognitive Impairment Computerized Assessment Battery developed by Neurotrax Corp. provides index scores in multiple cognitive domains, as well as a Global cognitive score
Secondary Outcome Measures
Full Information
NCT ID
NCT02388451
First Posted
February 26, 2015
Last Updated
January 20, 2019
Sponsor
Meir Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02388451
Brief Title
The Benefits of the Use of the Feuerstein Cognitive Training Method on Cognitive Function in Community-dwelling Older Patients With Mild Cognitive Impairment: a Pilot Study
Official Title
The Benefits of the Use of the Feuerstein Cognitive Training Method on Cognitive Function in Community-dwelling Older Patients With Mild Cognitive Impairment: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
August 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
15 subjects conforming to inclusion and exclusion criteria with a known clinical diagnosis of MCI and who provide informed consent will undergo cognitive and functional assessment to confirm the diagnosis of MCI. Baseline assessment using the Mindstreams Mild Cognitive Impairment Computerized Assessment Battery will be performed. Subjects will then participate 30 twice weekly meetings of 90 minutes duration each (for a total of 15 weeks). Mindstreams testing will be repeated after 15 sessions and at completion of the study.
Detailed Description
The rise in life expectancy in recent decades has resulted in a dramatic increase in the population of older people. This has been associated with a rise in the prevalence of age-associated conditions, particularly cognitive impairment and dementia. The prevalence of dementia in those older than 65 doubles every five years, and reaches a rate of more than 40% at age 85 years. Data from the World Health Organization predict 43 million dementia sufferers globally in the year 2020.
Mild Cognitive Impairment (MCI) is a syndrome comprising cognitive symptoms and impairment beyond population norms based on age and education, without functional loss. MCI represents a risk factor for dementia at a rate of conversion of approximately 12% annually. Thus patients with MCI characterize an important group for possible interventions in preventing further cognitive decline, particularly physical exercise and cognitive training.
The Feuerstein Program The Feuerstein Instrumental Enrichment (IE) program has been well-established as an effective intervention in other age groups and clinical situations. The method's creator, Professor Reuven Feuerstein, postulated that the thinking process is divided into three major phases - Input, Elaboration and Output - and that in each phase, different mental functions are at work. The quality of thinking depends upon the way the different functions are activated in each of the phases. The IE tools enable the correction or activation of cognitive deficiencies through use of targeted and focused mediation, which conserves and reinforces cognitive ability.
Recently, the Feuerstein Instrumental Enrichment Program for the Elderly was developed particularly for older people with cognitive decline.
Instrumental Enrichment can benefit all senior citizens, but is particularly recommended for those who do not constantly face intellectual challenges.
The process of learning IE is administered in group settings by instructors who have been trained to specifically mediate to the geriatric population. Work in groups constitutes a challenging, interesting and gratifying activity. It also appears that beyond contributing to the conservation and improvement of cognition, participating in the program may also have the effect of increasing feelings of competence, independence and improved emotional state.
15 subjects conforming to inclusion and exclusion criteria with a known clinical diagnosis of MCI and who provide informed consent will undergo cognitive and functional assessment to confirm the diagnosis of MCI. Baseline assessment using the Mindstreams Mild Cognitive Impairment Computerized Assessment Battery will be performed. Subjects will then participate 30 twice weekly meetings of 90 minutes duration each (for a total of 15 weeks). Mindstreams testing will be repeated after 15 sessions and at completion of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Mild Cognitive Impairment
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Feuerstein Program
Arm Type
Experimental
Arm Description
15 subjects conforming to inclusion and exclusion criteria with a known clinical diagnosis of MCI and who provide informed consent will undergo cognitive and functional assessment to confirm the diagnosis of MCI. Baseline assessment using the Mindstreams Mild Cognitive Impairment Computerized Assessment Battery will be performed. Subjects will then participate 30 twice weekly meetings of 90 minutes duration each (for a total of 15 weeks). Mindstreams testing will be repeated after 15 sessions and at completion of the study.
Intervention Type
Device
Intervention Name(s)
Feuerstein Program
Intervention Description
The IE activity is administered by instructors in groups of 10 to 15 participants. The intervention comprises 30 twice weekly meetings of 90 minutes duration per group.
Primary Outcome Measure Information:
Title
Mindstreams Mild Cognitive Impairment Computerized Assessment Battery
Description
The Mindstreams Mild Cognitive Impairment Computerized Assessment Battery developed by Neurotrax Corp. provides index scores in multiple cognitive domains, as well as a Global cognitive score
Time Frame
Change from Baseline Cognitive Function at 15 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 65 years and older
Able to read and speak Hebrew
Provide informed consent for participation in the study
Clinical diagnosis of MCI based on Consensus Criteria
A score of lower than 95 on the Memory Index of the Mindstreams Mild Cognitive Impairment Computerized Assessment Battery
Exclusion Criteria:
A medical condition (such as advanced heart failure, unstable ischemic heart disease, a lung condition with dyspnea on mild effort, intractable pain) or functional impairment (especially limiting mobility without the home) that does not allow the subject to participate in the training activities for the full duration of the study
A diagnosis of depression, bipolar disorder or schizophrenia
A cognitive diagnosis other than MCI, such as delirium, dementia or mental retardation
Visual impairment not corrected by the use of spectacles
Hearing impairment not corrected by hearing aids
Facility Information:
Facility Name
Yan Press
City
Beer-Sheva
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
The Benefits of the Use of the Feuerstein Cognitive Training Method on Cognitive Function in Community-dwelling Older Patients With Mild Cognitive Impairment: a Pilot Study
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