Protocol summary

Study aim
Determining the effect of aerobic exercise on cognitive function in patients with bipolar disorder
Design
This study is a clinical trial without control group that is not blinded and will be performed on 20 male patients with bipolar disorder in Parham Psychiatric Care Center.
Settings and conduct
This study will be performed at Parham Psychiatric Care Center.Twenty men with bipolar disorder participate in this study. At the beginning of the study, men with bipolar disorder are tested for Eckman and Stroop, and after 3 months of aerobic exercise (twice a week for 30 minutes) are retested.
Participants/Inclusion and exclusion criteria
inclusion criteria: Patients with bipolar disorder, Physical health (especially lung, heart health) - Age 20 to 60 years - Conscious satisfaction, At least 6 months stay in the center exclusion criteria: Trauma during exercise Physical problems during exercise
Intervention groups
This study is a pre- and post-intervention study and does not have a control group. Twenty men with bipolar disorder participate in this study. At the beginning of the study, men with bipolar disorder are tested for Ekman and Stroop, and after 3 months of aerobic exercise (twice a week for 30 minutes) are retested.
Main outcome variables
Emotional cognition -Social cognition -Short-term memory-Functional memory-Selective attention-Sustained attention

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210418051006N1
Registration date: 2021-05-01, 1400/02/11
Registration timing: registered_while_recruiting

Last update: 2021-05-01, 1400/02/11
Update count: 0
Registration date
2021-05-01, 1400/02/11
Registrant information
Name
amirreza khorshidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 9111
Email address
khorshidipaji@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-09, 1400/01/20
Expected recruitment end date
2021-07-11, 1400/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the aerobic exercise effects on the bipolar patients cognitional function
Public title
The effect of exercise on bipolar disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with bipolar disorder Lack of physical disabilities and mental retardation
Exclusion criteria:
Existence of underlying diseases for which intense exercise is harmful to health. General change of patients' medication protocol
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: 20
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
Vice Chancellor for Research, - Kashan University of Medical Sciences, 5 km Qutb Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Approval date
2021-03-10, 1399/12/20
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1400.001

Health conditions studied

1

Description of health condition studied
bipolar disorder
ICD-10 code
F31
ICD-10 code description
Bipolar disorder

Primary outcomes

1

Description
Emotional cognition
Timepoint
At the beginning of the intervention and 3 months after
Method of measurement
Ekman test

2

Description
Social cognition
Timepoint
The beginning of the study and three months after
Method of measurement
Ekman test

3

Description
short term memory
Timepoint
At the beginning of the study and 3 months later
Method of measurement
Stroop test

4

Description
Functional memory
Timepoint
At the beginning of the study and 3 months later
Method of measurement
Stroop test

5

Description
Selective attention
Timepoint
At the beginning of the study and 3 months later
Method of measurement
Stroop test

6

Description
Sustained attention
Timepoint
At the beginning of the study and 3 months later
Method of measurement
Stroop test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention group: In this study, aerobic exercise means fast and regular movements of the neck, arms, legs and back in a specific training package that is performed twice a week for 30 minutes each time by the exercise instructor and the same movements in each session.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Parham Rehabilitation and Treatment Center
Full name of responsible person
Dr.ghoreishi
Street address
In front of Parsian Bank, the beginning of Amir Emad St, Shahid Rajaei St.
City
Kashan
Province
Isfehan
Postal code
8715973446
Phone
+98 21 5554 9111
Email
khorshidipaji-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
Vice Chancellor for Research and Technology, Kashan University of Medical Sciences, - the end of Parstar Boulevard, 5 km of Qutb Ravandi Boulevard
City
Kashan
Province
Isfehan
Postal code
8715988141
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?
No
Title of funding source
kashan university of medical science
Proportion provided by this source
45
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
Amirreza khorshidipaji
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Unit 16, Complex-Block b, -Danesh Alley 25-Danesh , Danesh Boulevard
City
Kashan
Province
Isfehan
Postal code
8714884402
Phone
+98 31 5554 9111
Email
Khorshidipaji@kaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. fatemeh ghoreishi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Vice Chancellor for Research and Technology, Kashan University of Medical Sciences the end of Parstar Boulevard, 5 km of Qutb Ravandi Boulevard
City
Kashan
Province
Isfehan
Postal code
8715973446
Phone
+98 31 5554 9111
Email
Dr.zoghoreishi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Amireza khorshidipaji
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Unit 16, Block b, Danesh Complex, Danesh Alley 25, Danesh Boulevard
City
Kashan
Province
Isfehan
Postal code
8714884402
Phone
+98 31 5554 9111
Email
Khorshidipaji@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
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not 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
Loading...