The Effectiveness of stationary bike combined with attention process training on the positive and negative symptoms and cognitive deficits in schizophrenic patient
Evaluation effect of stationary bike combined with attention process training on the positive and negative symptoms and cognitive deficits in schizophrenic patient
Design
This study is clinical trial and double blind. patients will be divided in 2 groups by simple randomization.Groups are parallel.
Settings and conduct
Patients with schizophrenia inAmirkabir hospital in Arak will enter this study. This study is double blind. Researcher who complete questionnaire and analyzer and participant are blind (double blind).
Participants/Inclusion and exclusion criteria
Inclusion criteria: All schizophrenic patients undergoing drug treatment regardless of sex and age
Exclusion criteria:Patients with organic disorder; patients with schizophrenia who are not controlled by drug therapy; bipolar patients
Intervention groups
Intervention group: We will treat 50 patients with schizophrenia by intervention treatment of attention processing training with constant cycling.
Control group: We will treat 50 patients with schizophrenia without any intervention.
Main outcome variables
Negative and positive symptoms assessment; continuous attention assessment; focused attention; segmented attention; selective attention; short term memory assessment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N120
Registration date:2019-09-10, 1398/06/19
Registration timing:registered_while_recruiting
Last update:2019-09-10, 1398/06/19
Update count:0
Registration date
2019-09-10, 1398/06/19
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of stationary bike combined with attention process training on the positive and negative symptoms and cognitive deficits in schizophrenic patient
Public title
The Effectiveness of stationary bike combined with attention process training on the positive and negative symptoms and cognitive deficits in schizophrenic patient
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
All schizophrenic patients undergoing drug treatment regardless of sex and age
Exclusion criteria:
Patients with organic disorder
Patients with schizophrenia who are not controlled by drug therapy
Bipolar patients
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with randomization with envelopes in two groups A and B .
In this method, we selected a number of cards or letters as an intervention group and the same number of cards for the control group, then the cards were merged. One card was taken out and its allocation was registered and the card was returned to the other cards after leaving. Then the cards are merged again and we remove another card. This process continues to reach a random sequence according to sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blind. Researcher who complete questionnaire and analyzer and participant are blind (double blind). Outcome assessor and analyzer don't aware from grouping.The person evaluating the outcome is unaware of the grouping. Groups A and B are available to analyzer and outcome assessor.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Arak University of Medical Sciences
Street address
Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2019-04-07, 1398/01/18
Ethics committee reference number
IR.ARAKMU.REC.1398.005
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Negative and positive symptoms assessment
Timepoint
Before intervention and after 24 sessions
Method of measurement
Positive and negative syndrome scale(PANSS)
2
Description
Continuous attention assessment
Timepoint
Before intervention and after 24 sessions
Method of measurement
Continuous Performance Testing
3
Description
Focused attention
Timepoint
Before intervention and after 24 sessions
Method of measurement
Wechsler cryptography sub scale
4
Description
Segmented attention
Timepoint
Before intervention and after 24 sessions
Method of measurement
Subset of a number sequence- Wechsler intelligence test
5
Description
Selective attention
Timepoint
Before intervention and after 24 sessions
Method of measurement
Stroop test
6
Description
Short term memory assessment
Timepoint
Before intervention and after 24 sessions
Method of measurement
Wechsler direct and reverse digit span
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: We will treat 50 patients with schizophrenia by intervention treatment of attention processing training with constant cycling.Intervention time is 24 sessions per week for three sessions and intervention time is 3 minutes per session.
Category
Treatment - Other
2
Description
Control group: We will treat 50 patients with schizophrenia without any intervention.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir hospital
Full name of responsible person
Dr Mostafa Nokani
Street address
Amirkabir hospital, Parastar squre
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
m.nokani@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mohammad Arjmandzadegan
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
arjmandzadegan@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?