The effect of aerobic exercise as auxiliary therapy on the improvement of the negative and cognitive symptoms of patients with chronic schizophrenia in a randomized clinical case-control study .
Determination of the Effect of Aerobic Exercise as an Adjuvant Therapy on the Improvement of Negative and Cognitive Signs in Schizophrenic Patients
Design
A double-blind randomized clinical trial with case-control groups
Settings and conduct
Randomized double blind randomized clinical trial, Imam Hossein Hospital, Karaj and Roozbeh Tehran
Participants/Inclusion and exclusion criteria
Criteria for entering the study: having diagnostic criteria for DSM-V for patients with schizophrenia; the PANSS60 is the lowest score; age 18 to 50 years old; obtain informed consent from patient care; at least 2 years after the onset of the disease; minimum patient score based on negative subscore 20.
Exit criteria: significant neurological or organoleptic disease, cardiovascular disease and history of cardiac surgery, or any cardiovascular procedure, clinically and laboratory examinations, and case study and biographies of the family; there is another diagnosis in axis I based on DSM-V; IQ of less than 70 based on Clinical Clinical suspic; get the ECT in the last two weeks; having Major Depression Criteria or Top 4 Scores Based on PANSS Depression; the desire and suicide attempt in Hamilton; patients drinking alcohol simultaneously; patients with a history of drug use in the last 6 months; women of childbearing age are not admitted without adequate prophylaxis; CHF and liver patients.
Intervention groups
Patients with chronic schizophrenia
Main outcome variables
Negative and cognitive symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190316043072N1
Registration date:2019-03-31, 1398/01/11
Registration timing:registered_while_recruiting
Last update:2019-03-31, 1398/01/11
Update count:0
Registration date
2019-03-31, 1398/01/11
Registrant information
Name
Atefeh Zandifar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3255 4132
Email address
zandifaratefe@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-01, 1397/08/10
Expected recruitment end date
2019-05-21, 1398/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aerobic exercise as auxiliary therapy on the improvement of the negative and cognitive symptoms of patients with chronic schizophrenia in a randomized clinical case-control study .
Public title
The effect of aerobic exercise as auxiliary therapy on the improvement of the negative and cognitive symptoms of patients with chronic schizophrenia in a randomized clinical case-control study .
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having diagnostic criteria for DSM-V for patients with schizophrenia
The PANSS60 is the lowest score
Age 18 to 05 years old
Obtain informed consent from patient care at least 2 years after the onset of the disease
Minimum patient score based on Negative subscore 20
Exclusion criteria:
Significant neurological or organoleptic disease, cardiovascular disease and history of cardiac surgery, or any cardiovascular procedure, clinically and laboratory examinations, and case study and biographies of the family.
There is another diagnosis in axis I based on DSM-Vo IQ of less than 70 based on Clinical Clinical suspiciono Drug abuse (except nicotine and caffeine)
An anti-psychoactive oral intake in the past week or an anti-psychoactive effect in the past montho Get the ECT in the last two weekso Having Major Depression Criteria or Top 4 Scores Based on PANSS Depression
The desire and suicide attempt in Hamiltono Patients drinking alcohol simultaneously
Patients with a history of drug use in the last 6 months
Women of childbearing age are not admitted without adequate prophylaxis
CHF and liver patients
All patients are undergoing ECG and biochemical tests for liver and kidney disease.
All patients undergo five stages including basal and weekly visits in weeks 2- 4 and 6.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
50 patients were randomly assigned to control group and control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Researcher and analyst are not aware of patients who are under an intervention or non-intervention
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Alborz University of Medical Sciences
Street address
North Taleghani Blvd. Taleghani Square. Karaj. Alborz.IRAN
City
karaj
Province
Alborz
Postal code
3149779453
Approval date
2018-10-13, 1397/07/21
Ethics committee reference number
IR.ABZUMS.REC.1397.107
Health conditions studied
1
Description of health condition studied
Schizopherenia disorder
ICD-10 code
F20-29
ICD-10 code description
Schizophrenia, schizotypal and delusional disorders(F20-F29)
Primary outcomes
1
Description
Aerobic exercise
Timepoint
Weeks: 0, 2, 4, 6 and 8
Method of measurement
PANSS/ Brain MRI
2
Description
Negative and cognitive symptoms
Timepoint
Weeks: 0, 2, 4, 6 and 8
Method of measurement
PANSS/ Brain MRI
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with chronic schizophrenic disorder are randomly divided into two groups, if they have inclusion criteria. The intervention group is 25 people. In a 8-week program, 2mg of risperidone tablets are given at a dose of 6mg per day, and they are taking 3 days a week in aerobic exercises for 30 minutes per session.
Category
Treatment - Other
2
Description
Control group: control group of 25 people. In a 8-week program, risperidone tablets are given at a dose of 2 milligrams per day and not aerobic exercise.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital, Karaj
Full name of responsible person
Dr. Atefe Zandifar
Street address
North Taleghani Blvd. Taleghani Square. Karaj. Alborz.IRAN
City
karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3256 3324
Email
zandifaratefe@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Doctor Mohammad Norisephr
Street address
Deputy of Research and Technology-45 meters Golshahr - Alley Safarian - Karaj. Alborz.IRAN
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 4255
Email
Research@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
medical University Tehran . And Alborz University of Medical Sciences. Considering the patients are from Roozbeh Hospital in Tehran and Imam Hossein Hospital in Alborz. According to the approval of the project in both Rosabeh and Alborz research centers
Proportion provided by this source
50
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
Karaj University of Medical Sciences
Full name of responsible person
Dr. Atefe Zandifar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Araj- Taleghani Square- North Taleghani Blvd - Administrative City- Supreme Court of Justice- Alborz University of Medical Sciences
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 32563328026
Email
zandifaratefe@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Dr. Atefe Zandifar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
North Taleghani Blvd. Taleghani Square. Karaj. Alborz.IRAN
City
karaj
Province
Alborz
Postal code
3149779453
Phone
+98 32 5633 2802
Email
zandifaratefe@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Dr. Atefe Zandifar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
North Taleghani Blvd. Taleghani Square. Karaj. Alborz.IRAN
City
karaj
Province
Alborz
Postal code
3149779453
Phone
+98 32563328026
Email
zandifaratefe@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After publishing the article, people can access all the data without mentioning the patients' names
When the data will become available and for how long
Once the article is printed, people can access the data at any time
To whom data/document is available
Analyst / and eventually in the resulting research without the names of the sick
Under which criteria data/document could be used
For scientific use and benefit from the results to help patients with schizophrenia disorder after the publication of the article.
From where data/document is obtainable
After the publication and publication of the article, access to data is accessible by protecting the privacy of patients without their names.
What processes are involved for a request to access data/document
After the publication and publication of the article, access to data is accessible by protecting the privacy of patients without their names.