Determining the Effect of Aerobic Exercise on the Severity of Suicidal Ideation and Disease Symptoms in Schizophrenic Patients.
Design
A Randomized Controlled Clinical Trial, Single-blinded, on 30 Schizophrenic Patients. Even and odd numbers are used for random allocation.
Settings and conduct
The intervention of aerobic exercises will be carried out at the Mahdis Birjand Chronic Patients Care Center during 8 weeks and on even days of the week for 30 minutes, including warm-up, running and invisible rope jumping and cooling down.
Participants/Inclusion and exclusion criteria
Willingness to cooperate in research.
Have at least one period of hospitalization with a diagnosis of schizophrenia.
Age between 18 and 65 years.
In terms of physical health, have enough health to participate in the sports
program.
Not suffering from mental illness except schizophrenia
Not participating in another research project simultaneously
Intervention groups
For the intervention group, 30 minutes of aerobic exercises will be performed during 8 weeks on even days of the week, and for the control group, in order to consider ethical principles, a 30-minute session of aerobic exercises will be held after the end of the intervention.
Main outcome variables
Severity of Suicidal Ideation; Symptoms of Schizophrenia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240121060758N1
Registration date:2024-01-28, 1402/11/08
Registration timing:prospective
Last update:2024-01-28, 1402/11/08
Update count:0
Registration date
2024-01-28, 1402/11/08
Registrant information
Name
Sara Sheykh fendereski
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3235 3523
Email address
sara12345678sh@chmail.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2024-03-15, 1402/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Aerobic Exercise on the Severity of Suicidal Ideation and Disease Symptoms in Schizophrenic Patients
Public title
The Effect of Aerobic Exercise on the Severity of Suicidal Ideation and Disease Symptoms in Schizophrenic Patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to cooperate in research.
Have at least one period of hospitalization with a diagnosis of schizophrenia.
Age between 18 and 65 years.
In terms of physical health, have enough health to participate in the sports program.
Exclusion criteria:
Suffering from another mental illness except schizophrenia.
Participating in another research project at the same time
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, aerobic exercises will be performed for 8 weeks on even days of the week for 30 minutes, and at the end of the intervention, the control group will be taught the ethical considerations of aerobic exercises in one session.To consider single blinding , the participants will be informed that the intervention will take place at two different times.
Placebo
Not used
Assignment
Other
Other design features
In this study, aerobic exercises will be performed for 8 weeks on even days of the week for 30 minutes, and at the end of the intervention, the control group will be taught the ethical considerations of aerobic exercises in one session.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Birjand University of Medical Sciences
Street address
Ghafari Blvd.,Birjand University of Medical Science
City
Birjand
Province
South Khorasan
Postal code
9717853076
Approval date
2024-01-20, 1402/10/30
Ethics committee reference number
IR.BUMS.REC.1402.456
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
The Score of Suicidal Ideation in the Beck Questionnaire
Timepoint
Before the Start of the Intervention, The Second Week, The Fourth Week After the Start of the Intervention and After the End of the Intervention
Method of measurement
Beck Suicidal Ideation Questionnaire
2
Description
Score of Positive and Negative Syndrome Scale Questionnaire
Timepoint
Before the Start of the Intervention, The Second Week, The Fourth Week After the Start of the Intervention and After the End of the Intervention
Method of measurement
Positive and Negative Syndrome Scale Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Aerobic exercises will be performed for 15 patients with schizophrenia during 8 weeks on even days of the week for 30 minutes. These exercises include 5 minutes of warm-up (soft running, combined movements of arms and legs and stretching), 20 minutes of main exercise including 10 minutes of running with an intensity of 60 to 80% of the maximum heart rate and 10 minutes of invisible rope jumping in 5 sets (30 times in each set). After each set, patients will rest for 1 minute by running slowly in place and breathing deeply. At the end, it is 5 minutes to cool down and return to the initial position.
Category
Rehabilitation
2
Description
Control group: For 15 patients with schizophrenia, after the end of the intervention, aerobic exercises will be performed during one session for 30 minutes. These exercises include 5 minutes of warm-up (soft running, combined movements of arms and legs and stretching movements), 20 minutes of main exercise. It consists of 10 minutes of running at an intensity of 60-80% of maximum heart rate and 10 minutes of in situ invisible rope jumping in 5 sets (30 times per set). After each set, patients will rest for 1 minute by running slowly in place and breathing deeply. At the end, it is 5 minutes to cool down and return to the initial position.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahdis Birjand Chronic Patients Care Center
Full name of responsible person
Mehdi Majidi
Street address
Birjand, South Khorasan Province
City
Birjand
Province
South Khorasan
Postal code
1111111111
Phone
+98 915 561 0549
Email
Mahdi.mirhoseini99@bums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Masoud Yousefi
Street address
Ghafari Blvd.,Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
9717853076
Phone
+98 56 3239 5000
Fax
Email
webda@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Sara Sheykh fendereski
Position
Psychiatric Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.44, 3th Standard Ave., Standard Blvd
City
Gorgan
Province
Golestan
Postal code
4916698173
Phone
+98 17 3235 3523
Email
sara12345678sh@chmail.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Davood Oudi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ghafari Blvd., Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
9717853076
Phone
+98 56 3239 5000
Email
davoodoudi@bums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Sara Sheykh fendereski
Position
Psychiatric Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.44, 3th Standard Ave.,Standard Blvd
City
Gorgan
Province
Golestan
Postal code
4916698173
Phone
+98 17 3235 3523
Email
sara12345678sh@chmail.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
based on ethical issues
Study Protocol
No - There is not 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
The Effect of Aerobic Exercise on the Severity of Suicidal Ideation and Disease Symptoms in Schizophrenic Patients
When the data will become available and for how long
After the publication of the article
To whom data/document is available
nobody
Under which criteria data/document could be used
Under no circumstances
From where data/document is obtainable
nobody
What processes are involved for a request to access data/document