Protocol summary
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Study aim
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Determining the effect of cognitive, sports and music interventions on improving depression and balance in male schizophrenic patients
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Design
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The current research was a semi-experimental type with a pre-test and post-test design, which was implemented with seven groups
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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The ability to understand and speak.
presence of dementia(MMSE score >25
Get a score of 11 or above on the Beck Depression Inventory,
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Intervention groups
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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
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Main outcome variables
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deppresion
balance
Quality of Life
attention, working memory
General information
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Reason for update
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A primary outcome variable has been added
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Acronym
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IRCT registration information
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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
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Registration date
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2024-01-15, 1402/10/25
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-09-01, 1402/06/10
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Expected recruitment end date
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2023-12-31, 1402/10/10
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The Influence of Sport, Cognitive and Music rehabilitation on Depression, Balance, Quality of Life, attention and working memory in male schizophrenic
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Public title
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The Influence of Sport, Cognitive and Music rehabilitation on Depression and Balance in male schizophrenic
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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No age limit
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Gender
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Male
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple random sampling
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-09-20, 1402/06/29
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Ethics committee reference number
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IR.SSRC.REC.1402.136
Health conditions studied
1
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Description of health condition studied
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schizophrenia
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ICD-10 code
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F20
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ICD-10 code description
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Schizophrenia
Primary outcomes
1
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Description
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Depression score using Beck depression questionnaire
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Timepoint
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Before and after the intervention
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Method of measurement
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Beck questionnaire
2
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Description
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Dynamic balance
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Timepoint
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Before and after the intervention
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Method of measurement
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timed up and Go Test (TUG
3
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Description
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Schizophrenia Quality of Life Scale Revision 4
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Timepoint
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Before and after the intervention
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Method of measurement
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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
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Description
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Continuous Performance Test (CPT)
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Timepoint
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Before and after the intervention
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Method of measurement
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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
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Description
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N-back test
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Timepoint
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Before and after the intervention
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Method of measurement
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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
Intervention groups
1
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Description
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Intervention group 1: aerobic exercise group
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Category
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Rehabilitation
2
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Description
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Intervention group 2: Cognitive rehabilitation group
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Category
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Rehabilitation
3
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Description
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Intervention group3: music group
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Category
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Rehabilitation
4
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Description
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Intervention group4: Aerobic exercise + cognitive rehabilitation group
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Category
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Rehabilitation
5
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Description
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Intervention group 5: Aerobic training + music group
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Category
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Rehabilitation
6
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Description
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Intervention group: Cognitive rehabilitation + music group
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Category
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Rehabilitation
7
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Description
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Intervention group: Aerobic exercise + cognitive rehabilitation + music group
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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the University of Urmia
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Proportion provided by this source
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10
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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The analysis of information obtained from the results of the interventions on balance and deppresion can be published
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When the data will become available and for how long
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From the time the article was published until a year later
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To whom data/document is available
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All researchers
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Under which criteria data/document could be used
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Provided Someone wants to do a similar research project
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From where data/document is obtainable
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r.khanmohamadi65@yahoo.com
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What processes are involved for a request to access data/document
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Send request by email
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Comments
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