Today elderly population is growing. Cognitive disorders are the major health issues associated with this age group. These cognitive problems impose large economical and social costs on the society due to their impact on individual functioning. Mild Cognitive Impairment (MCI) is considered as a transient phase between normal aging and dementia. Nowadays, there is no effective treatment for MCI, so alternative therapies are under investigation. One of these methods is cognitive interventions. In this study we are going to assess the effect of cognitive rehabilitation on executive functioning in patients older than 60 years old with non-amnestic MCI, without any diagnostic criteria of dementia or any other major psychiatric problems. Patients were randomly divided into three groups of fifteen. The first group was assigned to life style interventions treatment, the second group was assigned to executive function rehabilitation, and finally the control group received educational pamphlets of other groups after six months of interventions. For all the patients we will assess neuropsychological tests before, just after and six months after interventions, and analyze the test scores differences. Note that double-blinding has been conducted throughout this experiment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201203029188N1
Registration date:2016-01-15, 1394/10/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-01-15, 1394/10/25
Registrant information
Name
Majid Barekatain
Name of organization / entity
Isfahan university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1222 2475
Email address
barekatain@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Science
Expected recruitment start date
2014-09-20, 1393/06/29
Expected recruitment end date
2015-10-23, 1394/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Cognitive Rehabilitation and Life Style Modification on Executive Function of Patients with Non Amnestic Mild Cognitive Impairment
Public title
effect of cognitive rehabilitation and life style modification on patients with mild cognitive intervention
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria :Age above 60 years; minimum 9 years of school education;NeuroCognitive Unite assesment (noucog) test score 75to 85 with executive function subscale score under 12 and memory subscale score above 15; /general Health Questioner(GHQ )test score under 22 ; physical ability to participate in training classes .
Exclusion criteria : complaint of disability in daily activities,
; major psychiatric or neurological diagnosis ; diagnosis of dementia; substance abuse with effect on cognitive abilities ; use of psychotropic drug with effect on cognitive abilities
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Commitee of Isfahanl University of Medical Siences
Street address
Ethics Commitee, Isfahan University of Medical Scienses, Hezarjerib Street, Isfahan, Iran
City
Isfahan
Postal code
Approval date
2014-08-27, 1393/06/05
Ethics committee reference number
393560
Health conditions studied
1
Description of health condition studied
mild cognitive impairment
ICD-10 code
786.5
ICD-10 code description
Personal history of other mental and behavioural disorders
Primary outcomes
1
Description
chenges of cognitive test's scores
Timepoint
Befor interventin-immediately after interventions-6months after intervention
Method of measurement
Go no go test
2
Description
chenges of cognitive test's scores
Timepoint
Before intervention-immediately after intervention-6months after intervention
Method of measurement
Design fluency test
3
Description
chenges of cognitive test's scores
Timepoint
Before intervention-immediately after intervention-6 months after intervention
Method of measurement
Five points test
4
Description
chenges of cognitive test's scores
Timepoint
Before intervention-immediately after intervention-6 months after intervention
Method of measurement
Category fluency test
5
Description
chenges of cognitive test's scores
Timepoint
Before intervention-immediately after intervention-6 months after intervention
Method of measurement
Tower of london test
6
Description
chenges of cognitive test's scores
Timepoint
Before intervention-immediately after intervention-6 months after intervention
Method of measurement
BRIEF-A
7
Description
chenges of cognitive test's scores
Timepoint
Before intervention-immediately after intervention-6 months after intervention
Method of measurement
Color trail making test
Secondary outcomes
1
Description
changes in scores of qialoty of life test
Timepoint
Before intervention-immediately after intervention-6months after intervention
Method of measurement
health promoting lifestyle test
Intervention groups
1
Description
"Intervention group:"
nine sessions of executive functions rehabilitation
Category
Rehabilitation
2
Description
" Control group"
will receive educational pamphlet of the other groups( after 6months)at the end of the assessments.
Category
Other
3
Description
" Intervention group":
Nine sessions of life style educations in the same time with the other intervention group
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Retired Educators Associaciation
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Mehdi Nematbakhssh
Street address
Vice chancellor for research, Isfahan University of Medical Scienses,Hezarjerib street,Isfahan,Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Maryam Alavirad
Position
Phsychiatric resident
Other areas of specialty/work
Street address
Behaiviorl Reaserch Center, Noor Hospital, Ostandari street, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 3222 2135
Fax
Email
maryamalavirad@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahanl University of Medical Siences
Full name of responsible person
Majid Barekatain
Position
Psychiatrist
Other areas of specialty/work
Street address
Behaiviorl Reaserch Center, Noor Hospital, Ostandari street, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 3222 2135
Fax
Email
barekatain@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)