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General information
The Influence of Sport, Cognitive and Music rehabilitation on Depression and Balance in male schizophrenic
The Influence of Sport, Cognitive and Music rehabilitation on Depression, Balance, Quality of Life, attention and working memory in male schizophrenic
The Influence of Sport, Cognitive and Music rehabilitation on Depression, Balance, Quality of Life, attention and Balanceworking memory in male schizophrenic
اثربخشی مداخلات شناختی، ورزشی و موسیقی بر افسردگی و تعادل بیماران اسکیزوفرنی مرد
اثربخشی مداخلات شناختی، ورزشی و موسیقی بر افسردگی و تعادل، کیفیت زندگی، توجه و حافظه کاری بیماران اسکیزوفرنی مرد
اثربخشی مداخلات شناختی، ورزشی و موسیقی بر افسردگی و تعادل، کیفیت زندگی، توجه و حافظه کاری بیماران اسکیزوفرنی مرد
Protocol summary
Study aim
Determining the effect of cognitive, sports and music interventions on improving depression and balance in male schizophrenic patients
Design
The current research was a semi-experimental type with a pre-test and post-test design, which was implemented with seven groups
Settings and conduct
The current research was a semi-experimental type with a pre-test and post-test design, which was implemented with seven groups. The statistical population of the research was male schizophrenic patients referred to the Urmia Psychiatric Center, and the statistics of these patients in the period of 2 months was 263. 60 schizophrenic patients with an average age of 39.12±8.90 were selected as samples from the target statistical population and randomly divided into 7 groups of 12 including 1) aerobic exercise group 2) cognitive rehabilitation group 3) Music group 4) Aerobic training + cognitive rehabilitation group 5) Aerobic training + music group 6) Cognitive rehabilitation + music group 7) Aerobic training + cognitive rehabilitation + music group were divided.
Participants/Inclusion and exclusion criteria
The ability to understand and speak.
presence of dementia(MMSE score >25
Get a score of 11 or above on the Beck Depression Inventory,
Intervention groups
1) Aerobic exercise group 2) Cognitive rehabilitation group 3) Music group 4) Aerobic exercise group + cognitive rehabilitation 5) Aerobic exercise group + music 6) Cognitive rehabilitation + music group 7) Aerobic exercise group + cognitive rehabilitation + music
Main outcome variables
deppresion
balance
Quality of Life
attention, working memory
General information
Reason for update
A primary outcome variable has been added
Acronym
IRCT registration information
IRCT registration number:IRCT20190908044722N2
Registration date:2024-01-15, 1402/10/25
Registration timing:retrospective
Last update:2024-11-16, 1403/08/26
Update count:2
Registration date
2024-01-15, 1402/10/25
Registrant information
Name
Razieh Khanmohamadi
Name of organization / entity
The university of Urmia
Country
Iran (Islamic Republic of)
Phone
+98 86 3221 4311
Email address
r.khanmohamadi@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-01, 1402/06/10
Expected recruitment end date
2023-12-31, 1402/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Influence of Sport, Cognitive and Music rehabilitation on Depression, Balance, Quality of Life, attention and working memory in male schizophrenic
Public title
The Influence of Sport, Cognitive and Music rehabilitation on Depression and Balance in male schizophrenic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The ability to understand and speak
Get a score of 11 or above on the Beck Depression Inventory
Exclusion criteria:
presence of dementia(MMSE score ≤25
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random sampling
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 Sport Sciences Research Institute
Street address
No. 3, Fifth Alley, Miramad Street, Tehran
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2023-09-20, 1402/06/29
Ethics committee reference number
IR.SSRC.REC.1402.136
Health conditions studied
1
Description of health condition studied
schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Depression score using Beck depression questionnaire
Timepoint
Before and after the intervention
Method of measurement
Beck questionnaire
2
Description
Dynamic balance
Timepoint
Before and after the intervention
Method of measurement
timed up and Go Test (TUG
3
Description
Schizophrenia Quality of Life Scale Revision 4
Timepoint
Before and after the intervention
Method of measurement
This scale , created it to measure HRQOL in individuals diagnosed with schizophrenia. Incorporated in two domains, psychosocial feelings (22 items) and cognition and vitality (11 items)
4
Description
Continuous Performance Test (CPT)
Timepoint
Before and after the intervention
Method of measurement
The CPT, is a psychological test used to assess a person's sustained attention, attention deficits and vigilance. It typically involves a computer-based task where the participant is required to respond to specific stimuli while ignoring distractors or non-target stimuli
5
Description
N-back test
Timepoint
Before and after the intervention
Method of measurement
During the n-back test, a visual stimulus is presented on the screen in the form of a randomly appearing sequence of numbers. It is necessary for the subject to verify if the stimulus currently being presented corresponds to the stimulus from the previous phase or not
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: aerobic exercise group
Category
Rehabilitation
2
Description
Intervention group 2: Cognitive rehabilitation group
Category
Rehabilitation
3
Description
Intervention group3: music group
Category
Rehabilitation
4
Description
Intervention group4: Aerobic exercise + cognitive rehabilitation group
Category
Rehabilitation
5
Description
Intervention group 5: Aerobic training + music group
Category
Rehabilitation
6
Description
Intervention group: Cognitive rehabilitation + music group
Category
Rehabilitation
7
Description
Intervention group: Aerobic exercise + cognitive rehabilitation + music group
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Urmia mental hospital
Full name of responsible person
Fatima Shamsali
Street address
Selmas Road
City
Urmia
Province
West Azarbaijan
Postal code
5719973356
Phone
+98 918 624 2003
Email
r.khanmohamadi@urmia.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
the University of Urmia
Full name of responsible person
Razieh KHanmohammadi
Street address
Urmia University, Kilometer 11 of Cypress Road - West Azarbaijan Province -Urmia
City
Urmia
Province
West Azarbaijan
Postal code
165
Phone
+98 44 3275 2741
Email
info@urmia.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
the University of Urmia
Proportion provided by this source
10
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
The university of Urmia
Full name of responsible person
Razieh Khanmohammadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Motor behavior
Street address
Urmia University, Kilometer 11 of Cypress Road ,Urmia, West Azerbaijan province
City
Urmia
Province
West Azarbaijan
Postal code
5756151818
Phone
شماره تلفنخانه : 43-32752741-044
Email
r.khanmohamadi@urmia.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
The university of Urmia
Full name of responsible person
Razieh Khanmohammadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
motor behavior
Street address
Urmia University, Kilometer 11 of Cypress Road, urmia,West Azarbaijan Province
City
Urmia
Province
West Azarbaijan
Postal code
5756151818
Phone
43-32752741-044
Email
r.khanmohamadi@urmia.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
The university of urmia
Full name of responsible person
Razieh Khanmohammadi
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
motor behavior
Street address
Urmia University, Kilometer 11 of Cypress Road, Urmia, West Azarbaijan Province
City
Urmia
Province
West Azarbaijan
Postal code
5756151818
Phone
43-32752741-044
Email
r.khanmohamdi@urmia.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is 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
The analysis of information obtained from the results of the interventions on balance and deppresion can be published
When the data will become available and for how long
From the time the article was published until a year later
To whom data/document is available
All researchers
Under which criteria data/document could be used
Provided Someone wants to do a similar research project
From where data/document is obtainable
r.khanmohamadi65@yahoo.com
What processes are involved for a request to access data/document