The effect of aerobic exercise on anxiety and depression in male patients with chronic schizophrenia
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 :
1) Confirmation of the diagnosis of schizophrenia in participating patients by a psychiatrist
2) At least 6 months Presence in the center
3) Ability to participate in regular sports programs.
Exclusion criteria:
1) Occurrence of any adverse event such as death, divorce or unemployment of the patient's first degree relatives during the study period
2) Existence of mental retardation or deafness or physical disability
3) Exit and clearance from the center
4) Change the general medication protocol of the patient
5) Drug use
6) Having underlying cardiovascular disease and diabetes, a history of stroke or lung or specific diseases
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). This study is an intervention study of before and after type and has no control group.
Main outcome variables
Depression with the Hamilton Depression questionnaire,
Anxiety with the Hamilton Anxiety questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210418051006N2
Registration date:2021-09-14, 1400/06/23
Registration timing:registered_while_recruiting
Last update:2021-09-14, 1400/06/23
Update count:0
Registration date
2021-09-14, 1400/06/23
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
2021-08-01, 1400/05/10
Expected recruitment end date
2022-01-30, 1400/11/10
Actual recruitment start date
2021-08-11, 1400/05/20
Actual recruitment end date
2022-02-09, 1400/11/20
Trial completion date
2022-02-09, 1400/11/20
Scientific title
The assessment of aerobic exercise effects on the depression and stress of the chronic schizophrenic patients
Public title
The effect of aerobic exercise on anxiety and depression in patients with chronic schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having schizophrenia
At least 6 months Presence in Parham rehabilitation and treatment Center
Exclusion criteria:
Occurrence of any adverse event such as death, divorce or unemployment of first-degree relatives
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
Kashan University of Medical Sciences, Parastar Blvd
City
Kashan
Province
Isfehan
Postal code
Approval date
2021-05-11, 1400/02/21
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1400.020
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
stress
Timepoint
The beginning of the intervention and the end of the intervention
Method of measurement
Hamilton Anxiety Questionnaire
2
Description
Depression
Timepoint
The beginning of the intervention and the end of the intervention
Method of measurement
Hamilton Depression Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study, the intervention is aerobic exercise. The exercise performed is similar to warming up before other exercises and morning exercise and does not involve heavy or complex movements that all patients are able to perform. It also involves stretching and strengthening the neck, back, and arms and legs of patients. Movements such as step in place, butterfly movement, step to side, double step to side, forward heel and jump in place, turning the waist and burpees movements and squatting the jack and raising the knee from behind and flattering, etc.
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
front of Parsian Bank, the beginning of Amir Emad Street, Shahid Rajaei Street, Kashan
City
kashan
Province
Isfehan
Postal code
8715973446
Phone
+98 31 5554 9111
Email
danceandtravelwithme@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr.Hamidreza Banafsheh
Street address
Deputy Research and technology, end of Parstar Blvd, 5 km from ghotb Ravandi, Kashan
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
Kargarnejad Hospital, Parstar Blvd, 5 km from Ghotbe Ravandi, Kashan
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
Kargarnejad Hospital, Parstar Blvd, 5 km from Ghotbe Ravandi, Kashan
City
Kashan
Province
Isfehan
Postal code
8715973446
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
Sara Hamzeh Nezhadi
Position
Psychiatric resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Kargarnejad Hospital, Parstar Blvd, 5 km from Ghotbe Ravandi, Kashan
City
Kashan
Province
Isfehan
Postal code
8715973446
Phone
+98 31 5554 9111
Email
danceandtravelwithme@gmail.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
For 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