The aim of this study was to investigate the effectiveness of volleyball on executive performance and daily living skills of patients with schizophrenia.
Design
Clinical trial with control group, with parallel, randomized groups, on 28 patients, simple randomization as coded envelopes has been used.
Settings and conduct
Daily Center for Neuropsychiatric Patients in Nowshahr.
The control group received conventional occupational therapy, including targeted, creative, and recreational activiti.
The intervention group played volleyball in addition to these interventions. Volleyball was held 60 minutes.
Assessment tools used for both control and intervention groups three times ; pre and post intervention and follow up.
Participants/Inclusion and exclusion criteria
The inclusion criteria :
diagnosed with schizophrenia based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
permission from psychiatric specialist to participate.
An intelligence score above 70 based on the adult version of the Wechsler scale.
The exclusion criteria:
Patients who had drug interactions three months before the intervention.
Intervention groups
The control group received routine occupational therapy interventions.
The intervention group played volleyball in addition to these interventions.
Main outcome variables
executive function ; daily living skills
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191102045312N1
Registration date:2020-05-26, 1399/03/06
Registration timing:registered_while_recruiting
Last update:2020-05-26, 1399/03/06
Update count:0
Registration date
2020-05-26, 1399/03/06
Registrant information
Name
Maryam Khazaeipoul
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 5232 4810
Email address
maryamkhazaeipoul@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-05-19, 1399/02/30
Actual recruitment start date
2019-12-26, 1398/10/05
Actual recruitment end date
2020-06-19, 1399/03/30
Trial completion date
2020-06-19, 1399/03/30
Scientific title
The effectiveness of volleyball exercises on executive function and daily living skills in people with schizophrenia.
Public title
Investigating the effect of volleyball on schizophrenia
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
diagnosed with schizophrenia based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
permission from psychiatric specialist to participate.
An intelligence score above 70 based on the adult version of the Wechsler scale
Exclusion criteria:
Patients who had drug interactions three months before the intervention.
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
28
Actual sample size reached:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into control and intervention groups.
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
Iran National Committee For Ethics in Biomedical Research
Street address
Rehabilitation faculty of Tehran University of Medical Sciences, Picheshemiran, Enghelab Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1148965111
Approval date
2019-12-25, 1398/10/04
Ethics committee reference number
IR.TUMS.FNM.REC.1398.157
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20-F29
ICD-10 code description
Schizophrenia, schizotypal and delusional disorders(F20-F29)
Primary outcomes
1
Description
Executive Function
Timepoint
Pre and post intervention and follow up(One month after the intervention)
Pre and post intervention and follow up(One month after the intervention)
Method of measurement
The Functional Independence Measure
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: conventional occupational therapy, including targeted, creative, and recreational activities and played volleyball in addition to these interventions. Volleyball was held 60 minutes, in three days a week, for 2 months.
Category
Rehabilitation
2
Description
Control group: The control group received conventional occupational therapy, including targeted, creative, and recreational activities.participants were blind to therapies they received.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive Rehabilitation Center for Chronic Psychiatric Patients Dr. Gharib (Daily)
Full name of responsible person
Maryam Khazaei Poul
Street address
Aseman Ave, karimi Blvd
City
nowshahr
Province
Mazandaran
Postal code
4651613949
Phone
+98 11 5232 5937
Email
Tavanbakhshii@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
AmirAli Sohrabpour
Street address
Vice chancellor for education,7th floor,Tehran University of Medical Sciences, Ghods St., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 81631
Email
tums_edu@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Maryam Khazaei Poul
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Isar Ave., kheryan Blvd.
City
Nowshahr
Province
Mazandaran
Postal code
4651688843
Phone
+98 11 5232 4810
Email
maryamkhazaeipoul@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parvin Raji
Position
Assiatant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Rehabilitation faculty of Tehran University of Medical Sciences, Picheshemiran, Enghelab Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 8798
Email
praji@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Khazaei Poul
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Isar Ave., khyrian Blvd.
City
nowshahr
Province
Mazandaran
Postal code
4651688843
Phone
+98 11 5232 4810
Email
Maryamkhazaeipoul@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
Due to the principles of fiduciary duty.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
After identifying individuals, the scores of executive function and daily living activities and information related to the main outcome of the study are shared.
When the data will become available and for how long
Start access after printing the results.
To whom data/document is available
Researchers working in academic and scientific institutions,Occupational therapists, infected patients and caregivers.
Under which criteria data/document could be used
The output of this project will be in the form of an article that will be made available to the public after its publication.All stakeholders, including researchers, occupational therapists, and psychologists, are allowed to request unidentified personal data. There is no restriction on the use of documents and statistical analysis of unidentifiable personal data.
Conditions for submitting an application:
Specify the field of work
Mention the reasons for the request
From where data/document is obtainable
Maryamkhazaeipoul@yahoo.com
Maryam Khazaei Poul
What processes are involved for a request to access data/document
There is no specific process that will be made available to the public for free after the article is published.After reviewing the request to receive unidentifiable data, the information will be received by the applicant within one week.