Protocol summary

Summary
This study is a randomized clinical trial to evaluate the effect of regular aerobic exercise on positive and negative symptoms and quality of life of male patients with chronic schizophrenia hospitalized in Razi Psychiatric Center.Researchers first among male patients hospitalized in Razi psychiatric hospital with a diagnosis of chronic schizophrenia,based on inclusion criteria will select and in terms of duration, severity of illness, medication (from a medical family) and two of the same age as two of and then random allocation (randomization) participants into two groups, with the two cards on one of their number 1 (intervention) and on the other card number 2 (control) is written, will be done.The samples selected for each of the cards will be in the intervention and control groups. The training program includes eight weeks, 3 sessions per week and each session includes a 5 minute warm-up program with a variety of Doha, stretching and exercise will be. training is added. after 8 weeks of training at post-test two groups of subjects participate.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016020823525N3
Registration date: 2016-02-26, 1394/12/07
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-02-26, 1394/12/07
Registrant information
Name
Hossein Namdar Areshtanab
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3479 6770
Email address
namdarh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2016-04-08, 1395/01/20
Expected recruitment end date
2016-07-10, 1395/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of regular aerobic exercise on positive and negative symptoms and quality of life of patients with schizophrenia Razi university hospital. A double blinded study
Public title
The effect of exercise on quality of life in patients with schizophrenia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: a definitive diagnosis of chronic schizophrenia by psychiatrist ; having a complete physical health to participate in the intervention (physical examination by a doctor and check with previous history of physical illness); the ability to cooperate and respond to Questions ;No problems with foot such as ulceration and scarring; willingness to participate in the study ; aware and alert. Exclusion criteria: physical problems during the intervention ; having cerebral organic lesions; patients who for any reason you wish to continue do not have cooperation; discharge
Age
From 25 years old to 55 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 68
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Golghasht Ave.
City
Tabriz
Postal code
Approval date
2016-02-01, 1394/11/12
Ethics committee reference number
TBZMED.REC.1394.1019

Health conditions studied

1

Description of health condition studied
Schizophrenia
ICD-10 code
F20.0,F20.
ICD-10 code description
Paranoid schizophrenia,Hebephrenic schizophrenia,Catatonic schizophrenia,Undifferentiated schizophrenia,Residual schizophrenia,Schizophrenia, unspecified

Primary outcomes

1

Description
Positive symptoms
Timepoint
A week before the intervention, immediately after intervention
Method of measurement
Anderson positive symptom scale

2

Description
Negative Symptoms
Timepoint
A week before the intervention, immediately after intervention
Method of measurement
Anderson Negative symptom scale

3

Description
Quality of Life
Timepoint
A week before the intervention, immediately after intervention
Method of measurement
Schizophrenic quality of life scale

Secondary outcomes

1

Description
Heart rate at rest
Timepoint
Immediately before the intervention, immediately after intervention
Method of measurement
Beurer rate monitor

2

Description
Age
Timepoint
beforethe intervention
Method of measurement
year

Intervention groups

1

Description
Regular aerobic exercise Including 3 times a week and each session included a five-minute warm-up program with a light running, stretching and then in the first week,subjects will run at 65% heart rate reserve for 12 minutes that it to 26 minutes at 80% heart rate reserve will be in week eight . Immediately before and after the intervention, blood pressure and heart rate will be measured .As for the control group is considered a walk in the open air.
Category
Other

2

Description
For the control group during the intervention is intended for walking in fresh air.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz Razi hospital
Full name of responsible person
Hossein Namdar Areshtanab
Street address
Tabriz- South Shariati Ave. Nursing and midwifery faculty
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Tabriz-Gholghashet Ave.Vice Chancellor for Research
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Shahram Piri
Position
Masters student
Other areas of specialty/work
Street address
Tabriz-South shariati Ave. Nursing and midwifery faculty
City
Tabriz
Postal code
5138947977
Phone
+98 41 3658 0856
Fax
+98 41 3479 6969
Email
pirishahram67@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Hossein Namdar Areshtanab
Position
Phd in nursing education
Other areas of specialty/work
Street address
Tabriz- south shariati Ave. nursing and midwifery faculty
City
Tabriz
Postal code
51745347
Phone
+98 41 3479 6770
Fax
Email
namdarh@tbzmed.ac.irhna442000@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Hossein Namdar Areshtanab
Position
Phd in nursing education
Other areas of specialty/work
Street address
Tabriz- south shariati Ave. nursing and midwifery faculty
City
tabriz
Postal code
5138947977
Phone
+98 41 3470 6770
Fax
+98 41 3479 6969
Email
namdarh@tbzmed.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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