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The effectiveness of neurobic exercises on cognitive functions, quality of life, anxiety and depression in the elderly

Protocol summary

Study aim
The purpose of this study is to investigate the effectiveness of neurobic exercises on cognitive functions, quality of life, anxiety, and depression of the elderly in Sirjan City.
Design
A clinical trial with the control group, with parallel groups, randomized and unblinded with 30 elderly people
Settings and conduct
After randomly replacing the participants into groups, the intervention group will receive interventions based on neurobic exercises for 6 sessions of 90 minutes twice a week. The place of the intervention will be Dr. Shams Aldini Comprehensive Health Service Center in Sirjan city
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age range from 60 to 74 years, having mild cognitive disorders and anxiety and depression, not suffering from epilepsy and vision and hearing problems and severe physical disabilities. Criteria for not entering the study: presence of dementia; presence of personality disorders; The presence of clinical conditions that require immediate treatment
Intervention groups
Intervention group: they will receive two 90-minute sessions of neurobic exercises per week by an experienced clinical psychologist. Before the intervention and after the intervention, anxiety, depression, quality of life and cognitive function of the samples will be examined. Control group: In this study, no intervention will be done for the control group until the end of the follow-up, and after the end of the study, they will receive several similar training sessions.
Main outcome variables
Cognitive functions, Anxiety, Depression, Quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230228057557N2
Registration date: 2024-07-07, 1403/04/17
Registration timing: prospective

Last update: 2024-07-07, 1403/04/17
Update count: 0
Registration date
2024-07-07, 1403/04/17
Registrant information
Name
Maryam Kooraki
Name of organization / entity
Shahid Chamran University of Ahvaz
Country
Iran (Islamic Republic of)
Phone
+98 913 845 4197
Email address
m-kooraki@stu.scu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-10, 1403/04/20
Expected recruitment end date
2024-08-21, 1403/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of neurobic exercises on cognitive functions, quality of life, anxiety and depression in the elderly
Public title
The neurobic exercises and cognitive functions, quality of life, anxiety and depression in the elderly
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
diagnosis of mild cognitive disorders by a psychiatrist High and moderate level of anxiety and depression using the study tool expressing willingness and informed consent to participate in the research Not suffering from epilepsy Lack of vision, hearing and severe physical disabilities Age range 60 to 74 years
Exclusion criteria:
Not cooperating with the therapist and other members of the group Absence of more than two sessions Receiving any other training or treatment during the research period. Non-cooperation in completing the questionnaires
Age
From 60 years old to 74 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is a simple randomization. The study has two groups and from the beginning it is agreed that odd numbers will be given to the intervention group and even numbers will be given to the control group. Then, using the random number table, the corresponding numbers are extracted, each number is written on a card and placed in an envelope, and the envelopes are sealed, and the patient's number is written on each envelope, and the first patient who entered the study Envelope number 1, patient number 2, envelope number 2 and so on will be given.
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 Shahid Chamran University of Ahvaz
Street address
Golestan Boulevard, Shahid Chamran University of Ahvaz, Faculty of Educational Sciences and Psychology, Shahid Chamran University of Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۳۵۷۸۳۱۵۱
Approval date
2024-06-23, 1403/04/03
Ethics committee reference number
IR.SCU.REC.1403.047

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified

2

Description of health condition studied
Depression
ICD-10 code
F32.1
ICD-10 code description
Four or more of the above symptoms are usually present and the patient is likely to have great difficulty in continuing with ordinary activities.

Primary outcomes

1

Description
Cognitive functions
Timepoint
Before the start of the intervention, after the end of the intervention, and 3 months after the end of the intervention
Method of measurement
Addenbrooke's Cognitive Examination (ACE)

2

Description
Anxiety
Timepoint
Before the start of the intervention, after the end of the intervention and 3 months after the end of the intervention
Method of measurement
Geriatric Anxiety Scale

3

Description
Depression
Timepoint
Before the start of the intervention, after the end of the intervention and 3 months after the end of the intervention
Method of measurement
Geriatric Depression Scale (GDS)

Secondary outcomes

1

Description
Quality of life
Timepoint
Before the start of the intervention, after the end of the intervention and 3 months after the end of the intervention
Method of measurement
Leipad Quality of Life in the elderly Questionnaire

Intervention groups

1

Description
The intervention group is trained in a 60-minute session about neurobic exercises and their application in life. Then 6 sessions of 90-minute interventions based on neurobic exercises, including stimulating the sense of sight (doing visual games, for example, placing some common kitchen tools and looking at them for one minute, then covering them and asking the subjects to remember how many of them brought), Olfactory (for example, the participants have to smell different smells with their eyes closed for one minute and then in a certain time they can identify the smelled smell), hearing (the participants are asked to smell different sounds with their eyes closed and with ear focus) data and then identify and remember them from other sounds), touch) as an activity, the participants are divided into two groups and one of the participants writes a word with his hand behind the second participant. He has to guess the word, taste (for example, the participants experience and identify the main tastes with their eyes closed) and receive the combination of senses. Each session has a goal and activities for the elderly that they do in the face-to-face session and the presence of the therapist, and the ultimate goal is to improve the cognitive functions, psychological states, and quality of life of the elderly.
Category
Lifestyle

2

Description
Control group: Control group: In this study, the members of the control group will not receive any training until the end of the follow-up phase, and after the completion of the follow-up phase, to comply with the research ethics, they will receive several similar training sessions.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Comprehensive health service centers of Sirjan City
Full name of responsible person
Maryam Kooraki
Street address
Golestan Boulevard, Shahid Chamran University of Ahvaz, Faculty of Educational Sciences and Psychology
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۳۵۷۸۳۱۵۱
Phone
+98 913 845 4197
Email
m-kooraki@stu.scu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sirjan Faculty of Medical Sciences
Full name of responsible person
Maryam Kooraki
Street address
Sirjan Blvd. Seyed Jamaluddin Asadabadi, next to Traffic Park - Postal code: 7816916338
City
Sirjan
Province
Kerman
Postal code
7816916338
Phone
+98 913 845 4197
Email
m-kooraki@stu.scu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sirjan Faculty of Medical Sciences
Proportion provided by this source
50
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
Sirjan university of Medical Science
Full name of responsible person
Maryam Kooraki
Position
Psychologist
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Sirjan Blvd. Seyed Jamaluddin Asadabadi, next to Traffic Park - Postal code: 7816916338
City
Sirjan
Province
Kerman
Postal code
7816916338
Phone
+98 913 845 4197
Email
m-kooraki@stu.scu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sirjan Faculty of Medical Sciences
Full name of responsible person
Maryam kooraki
Position
Psychologist
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Sirjan Blvd. Seyed Jamaluddin Asadabadi, next to Traffic Park
City
Sirjan
Province
Kerman
Postal code
7816916338
Phone
+98 913 845 4197
Email
m-kooraki@stu.scu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Sirjan Faculty of Medical Sciences
Full name of responsible person
Maryam Kooraki
Position
Psychologist
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Sirjan Blvd. Seyed Jamaluddin Asadabadi, next to Traffic Park
City
Sirjan
Province
Kerman
Postal code
7816916338
Phone
+98 913 845 4197
Email
m-kooraki@stu.scu.ac.ir

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
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Demographic information and clinical trial results
When the data will become available and for how long
3 months after the publication of the article
To whom data/document is available
researchers
Under which criteria data/document could be used
1. Researchers can refer to the current study by mentioning the source. 2. Researchers can compare the treatment approach used in the current study with other studies by mentioning the reference, or use it in the form of developing a new protocol by mentioning the reference.
From where data/document is obtainable
Send an email to the researcher in charge of the study (Maryam Kooraki) m-kooraki@stu.scu.ac.ir
What processes are involved for a request to access data/document
Send request by email
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