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Study of the Effect of Group Exercise Program on Quality of Life in War Veterans with Post Traumatic Stress Disorder

Protocol summary

Summary
randomized study, single blinded,control group receive no intervention, no control with placebo, sample: war veterans with post traumatic stress disorder, inclusion criteria: outpatient war veterans with post traumatic stress disorder; patients who do not have psychotic symptoms, mood disorders, addiction,...; exclusion criteria:inpatient war veterans with post traumatic stress disorder; war veterans who do exercises regularly; patients who diagnosed as mood disorder, personality disorder, psychotic disorder and addiction,.. in addition to post traumatic stress disorder; inability in answeing the checklist; sample size:26, intervention:group aerobic exercise, duration of intervention: 12 2-session weeks, and each session, each session about 1 hour

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012122911922N1
Registration date: 2013-03-16, 1391/12/26
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-03-16, 1391/12/26
Registrant information
Name
Batool Mandani
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1374 3101
Email address
mandani-b@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
musculoskeletal rehabilitation research center, Ahvaz jundishapur university of medical science, Ahvaz, Iran
Expected recruitment start date
2012-12-21, 1391/10/01
Expected recruitment end date
2013-01-19, 1391/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the Effect of Group Exercise Program on Quality of Life in War Veterans with Post Traumatic Stress Disorder
Public title
effect of exercise on quality of life in war veterans with PTSD
Purpose
Health service research
Inclusion/Exclusion criteria
inclusion criteria: outpatient war veterans with PTSD, war veterans who do not exercises regularly, who diagnosed as PTSD after the war, who do not have psychotic symptoms, mood disorders, addiction,...,exclusion criteria: persons with post traumatic stress disorder who are not war veterans,inpatient war veterans with ptsd, war veterans who do exercises regularly, who diagnosed as mood disorder, personality disorder, psychotic disorder and addiction,.. in addition to PTSD, inability to have communication, inability in answeing the checklist, undrestanding and responsing to the questions
Age
To 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 26
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Deputy of Research and Technology in Ahvaz Jundishapur University of Medical Sciences
Street address
Deputy of Research and Technology, Jundishapur University of Medical Sciences, Ahvaz
City
Ahvaz
Postal code
Approval date
2012-04-21, 1391/02/02
Ethics committee reference number
ETH-443

Health conditions studied

1

Description of health condition studied
post traumatic stress disorder
ICD-10 code
F43.1
ICD-10 code description
Post-traumatic stress disorder

Primary outcomes

1

Description
quality of life
Timepoint
before the intervention, 3 months after the intervention, 3 month after the end of intervention
Method of measurement
36 Item short form health survey(SF36)

Secondary outcomes

1

Description
mental and physical components scale of quality of life
Timepoint
before the intervention,3 month after the intervention, 3 month after the end of intervention
Method of measurement
36 item short form health survey

Intervention groups

1

Description
intervention group : group aerobic exercise program for 12 weeks, 2 sessions in every week and each session for 40 minutes
Category
Rehabilitation

2

Description
control group: no intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Jundishapour University of Medical Sciences
Full name of responsible person
Batool Mandani
Street address
Occupational therapy Department, Rehabilitation School, opposite the MRI Building, Jundishapour University of Medical Sciences, Ahvaz
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Hossein Negahban
Street address
Musculoskeletal Rehabilitation Research Center, Rehabilitation School, opposite the MRI Buildng, Jundishapur University of Medical Sciences, Ahvaz
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur 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
Musculoskeletal Rehabilitation Research Center
Full name of responsible person
Batool Mandani
Position
MS of occupational therapy
Other areas of specialty/work
Street address
Occupational therapy Department, Rehabilitation School, opposite the MRI Building, Jundishapour University of Medical Sciences, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61137431015
Fax
Email
mandani-b@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Musculoskeletal Rehabilitation Research Center
Full name of responsible person
Batool Mandani
Position
MS of occupational therapy
Other areas of specialty/work
Street address
Occupational therapy Department, Rehabilitation School, opposite the MRI Building, Jundishapour University of Medical Sciences, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61137431015
Fax
Email
mandani-b@ajums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Musculoskeletal Rehabilitation Research Center
Full name of responsible person
Batool Mandani
Position
MS of occupational therapy
Other areas of specialty/work
Street address
Occupational therapy Department, Rehabilitation School, opposite the MRI Building, Jundishapour University of Medical Sciences, Ahvaz
City
Ahvaz
Postal code
Phone
00
Fax
Email
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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