Determining the effect of aerobic exercise on social and emotional cognition of schizophrenia patients
Design
Before after trial without control group and with 30 participants
Settings and conduct
The study will be conducted at Parham Psychiatric Center in Kashan. Participants with schizophrenia will be selected if eligible for the study.
The study is not blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
No underlying disease such as lung or heart problems
Age 20 to 60 years
Confirmation of the diagnosis of schizophrenia
Patient desire to participate
The patient's ability to participate in regular exercise programs
Obtain consent from the patient's legal guardian before participating in the study
exclusion criteria:
Trauma during exercise
Physical problems during exercise
Absence for more than three sessions
Clearance from the center
Changing the general medication protocol of the patient
Drug use
Change in the patient's mental state
Intervention groups
The intervention group includes patients with schizophrenia who receive the intervention in the form of aerobic exercise for 6 months (twice a week).
The research is an intervention before and after and has no control group.
Main outcome variables
Stroop test of colored words; Numerical width stroop test score; Test the spacing of words
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210406050873N1
Registration date:2021-04-27, 1400/02/07
Registration timing:prospective
Last update:2021-04-27, 1400/02/07
Update count:0
Registration date
2021-04-27, 1400/02/07
Registrant information
Name
Aliakbar Ataei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 9111
Email address
ataei-a@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-11, 1400/01/22
Expected recruitment end date
2021-10-22, 1400/07/30
Actual recruitment start date
2021-04-30, 1400/02/10
Actual recruitment end date
2021-10-22, 1400/07/30
Trial completion date
2021-10-22, 1400/07/30
Scientific title
The assessment of the aerobic exercise effect on the schizophrenic patients social and emotional cognition
Public title
Aerobic exercise effect on the schizophrenic
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
No underlying disease such as lung or heart problems
Age 20 to 60 years
Confirmation of the diagnosis of schizophrenia
Patient desire to participate
The patient's ability to participate in regular exercise programs
Exclusion criteria:
Physical problems during exercise
Absence for more than three sessions
Clearance from the center
Change in the patient's mental state
Age
From 20 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Parastar boulevard
City
Kashsn
Province
Isfehan
Postal code
۸۷۱۵۹۷۳۴۴۶
Approval date
2021-03-16, 1399/12/26
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1400.007
Health conditions studied
1
Description of health condition studied
اسکیزوفرنی
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Stroop test of colored words
Timepoint
The beginning of the study and 6 months after that
Method of measurement
Stroop test of colored words
2
Description
Numbers test stroop score
Timepoint
The beginning of the study and 6 months after that
Method of measurement
Numbers test stroop score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study, the intervention is aerobic exercise that is twice a week for 6 months. In this study, aerobic exercise means fast and regular movements of the neck, arms, legs and back in a specific exercise package for 30 minutes each time (twice a week) by a sports coach, and the same movements are repeated in each session, which include movements such as butterfly, raising the opposite arm and leg, hitting around, rope, etc. In order to perform proper exercise in aerobic activity, heart rate is an indicator of activity intensity.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Parham Rehabilitation and Treatment Center
Full name of responsible person
dr. Afshin ahmadvand
Street address
Kashan, Shahid Rajaei St., at the beginning of Amir Emad St., in front of Parsian Bank
City
kashan
Province
Isfehan
Postal code
8715973446
Phone
+98 21 5554 9111
Email
ataei-a@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
hamidreza banafsheh
Street address
Kashan - 5 km from Ravandi pole - end of Parstar Boulevard - Deputy of research and technology
City
kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5554 2999
Email
banafshe57@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
dr. afshin ahmadvand
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Kashan - 5 km from Ravandi pole - end of Parstar Boulevard - Kargarnejad Hospital
City
kashan
Province
Isfehan
Postal code
8715973446
Phone
+98 31 5554 9111
Email
afshin.ahmadvand@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
dr. afshin ahmadvand
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Kashan - 5 km from Ravandi pole - end of Parstar Boulevard - Kargarnejad Hospital
City
kashan
Province
Isfehan
Postal code
7815973446
Phone
+98 31 5554 9111
Email
afshin.ahmadvand@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
aliakbar ataee
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Kashan - 5 km from Ravandi pole - end of Parstar Boulevard - Kargarnejad Hospital
City
kashan
Province
Isfehan
Postal code
8715973446
Phone
+98 31 5554 9111
Email
ataei@kaums.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
Because of moral considerations
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available