Investigating the effect of cognitive rehabilitation on cognitive function in the elderly with mild cognitive impairment.
Design
This is a randomized clinical trial with a parallel design and control group. This randomized, non-blinded study will be conducted on 78 eligible elderly people. A simple randomization method will be used for randomization, and participants will be assigned to three intervention groups (two intervention groups and one control group).
Settings and conduct
This study, which will be conducted at Farabi Hospital in Kermanshah, is non-blinded. At the beginning of the study, a cognitive function questionnaire will be provided to the elderly.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Informed consent; Age over 60 years; Obtaining a score between 18 and 25 on the Cognitive Performance Questionnaire; Having at least reading and writing skills
Exclusion criteria: History of drug or alcohol addiction; History of neurological disorders or other psychiatric disorders (such as Parkinson's, multiple sclerosis, dementia, schizophrenia, bipolar, major depression) as diagnosed by a physician
Intervention groups
In the first intervention group, the elderly will undergo cognitive intervention in person for 12 two-hour sessions twice a week. In the second intervention group, they will undergo cognitive intervention digitally via computer (Rehacom software) for 12 two-hour sessions twice a week. In the control group, no intervention will be performed.
Main outcome variables
Cognitive function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N271
Registration date:2025-12-27, 1404/10/06
Registration timing:prospective
Last update:2025-12-27, 1404/10/06
Update count:0
Registration date
2025-12-27, 1404/10/06
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-01-10, 1404/10/20
Expected recruitment end date
2026-03-16, 1404/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of cognitive rehabilitation on cognitive function in the elderly with mild cognitive impairment.
Public title
Investigating the effect of cognitive rehabilitation on cognitive function in the elderly
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent
Age over 60 years
Obtaining a score between 18 and 25 on the Cognitive Performance Questionnaire
Having at least reading and writing skills
Exclusion criteria:
History of drug or alcohol addiction
History of neurological disorders or other psychiatric disorders (such as Parkinson's, multiple sclerosis, dementia, schizophrenia, bipolar, major depression) as diagnosed by a physician
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
Using the simple random method. The names of the participants are written on the card. The cards are put into a box that cannot be seen from outside. One of the colleagues of the plan is asked to remove one card from the container at a time. The names of the 26 cards that are selected first are placed in the first intervention group, the second 26 selected cards are placed in the first control group, and the remaining 26 in the second control group
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Keranshah
Province
Kermanshah
Postal code
6715847141
Approval date
2025-12-16, 1404/09/25
Ethics committee reference number
IR.KUMS.REC.1404.545
Health conditions studied
1
Description of health condition studied
Mild cognitive imparment
ICD-10 code
G31.84
ICD-10 code description
Mild cognitive impairment, so stated
Primary outcomes
1
Description
Cognitive function
Timepoint
Beginning of the study and end of the study (after 12 intervention sessions)
Method of measurement
Using the Montreal Cognitive Assessment Scale
Secondary outcomes
empty
Intervention groups
1
Description
In the first intervention group, the elderly will undergo in-person cognitive intervention for 12 two-hour sessions twice a week. Cognitive domain intervention will include visual-spatial, attention, language, executive functions, and abstract thinking and judgment.
Category
Treatment - Other
2
Description
In the second intervention group, they will undergo cognitive intervention digitally via computer (RehaCom software) for 12 ,two-hour sessions twice a week. Cognitive domain intervention will include visual-spatial, attention, language, executive functions, and abstract thinking and judgment.
Category
Treatment - Other
3
Description
No intervention will be performed in the control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Farabi Hospital
Full name of responsible person
Yasaman Ghiasi
Street address
Farabi Hospital, Dolatabad Blvd, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6719851151
Phone
+98 83 3826 1046
Email
yasaman1431@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Zohreh Rahimi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
Zrahimi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Yasaman Ghiasi
Position
Master's degree student in Geriatric Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery Dolatabad Blvd, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
yasaman1431@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Parvin Abasi
Position
University faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery Dolatabad Blvd, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
p-abasi2003@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Parvin Abasi
Position
University faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
p-abasi2003@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD