Protocol summary

Summary
Materials and methods: In this research that purpose of the study is the effect of physical rehabilitation program on the fatigue and stress among of mustard chemical victims, sixty chemical mustard victims will select among clients of the chemical victims clinic of the Baqiyatallah hospital. After describing the purpose of the research and its methodology, gaining their agreement and filling paper of demographic information, a Multidimensional Fatigue and Fatigue Sevirity Questionnaires and the Perceived Stress Scale will give to them to fill. After filling questionnaires, the research units will divide into the experimental and the control groups. The experimental group will train for a physical rehabilitation plan. A rehabilitation plan includes a sport program (an arranged walking for 10 to 35 minutes for 3 to 5 days a week). The rehabilitation plan is proposed by a specialist in physical and sports medicine and guideline of the American College of Sports Medicine. In this plan, time of walking increase, according to then tolerance of the patient and commenced from 10 minutes per week and added 5 minutes to it every week and it will be 35 minutes at 6th week and the next weeks, it continues35 minutes every day. After two months, again, Fatigue and Stress questionnaires will done by experimental and control groups and the data will enter into SPSS software and ill analyze by statistical tests.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014080218654N1
Registration date: 2014-11-02, 1393/08/11
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-11-02, 1393/08/11
Registrant information
Name
Soheil Najafi Mehri
Name of organization / entity
University of medical sciences Baqiyatallah
Country
Iran (Islamic Republic of)
Phone
+98 21 8355 5046
Email address
s.najafi@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Sciences Vice chancellor for research, Baqiyatallah university of medical sciences
Expected recruitment start date
2014-07-23, 1393/05/01
Expected recruitment end date
2014-09-23, 1393/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of physical rehabilitation program on the fatigue and stress among of mustard chemical victims
Public title
The effect of rehabilitation on the fatigue and stress among of mustard chemical victims
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: To be a chemical mustard victim; To be able to fill the fatigue and stress questionnaires; To have the ability to perform physical rehabilitation program. Exclusion criteria: Dissatisfied of the injured to continue his cooperation at any steps physical rehabilitation.
Age
From 40 years old to 70 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
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 university of medical sciences Baqiyatallah
Street address
Velayat complex, Artesh Sq, Shahid Langari St, Noboniad Sq
City
Tehran
Postal code
1615998741
Approval date
2014-01-11, 1392/10/21
Ethics committee reference number
340/3/6770/س

Health conditions studied

1

Description of health condition studied
Stress
ICD-10 code
F43.8
ICD-10 code description
Other reactions to severe stress

2

Description of health condition studied
Fatigue
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Fatigue
Timepoint
Befor of intervention and 2 months after of intervention
Method of measurement
Fatigue Severity Scale Questionnaire and Multidimentional Fatigue Inventory Questionnaire

2

Description
stress
Timepoint
Befor of intervention and 2 months after of intervention
Method of measurement
Perceived Stress Scale Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Experiment group: Programmed Walking for 10 to 35 minutes, 3 to 5 days a week, for 2 months
Category
Rehabilitation

2

Description
Control group: Without any program
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
clinic of Baqiyatallah Hospital
Full name of responsible person
Ali Ahmadi Dastjerdi
Street address
Next to the Sheikh Bahaie St, Molla Sadra St, vanak Sq
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sciences Vice chancellor for research, Baqiyatallah university of medical sciences
Full name of responsible person
Sciences Vice chancellor for research, Baqiyatallah university of medical sciences
Street address
Velayat complex, Artesh Sq, Shahid Langari St, Noboniad Sq
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sciences Vice chancellor for research, Baqiyatallah 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
University of medical sciences Baqiyatallah
Full name of responsible person
Dr.Amir Vahedian Azimi
Position
PhD Assistant Professor
Other areas of specialty/work
Street address
Velayat complex, Artesh Sq, Shahid Langari St, Noboniad Sq
City
Tehran
Postal code
1615998741
Phone
+98 212612737
Fax
+98 212612737
Email
Amirvahedian63@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of medical sciences Baqiyatallah
Full name of responsible person
Dr.Soheil Najafi Mehri
Position
Nursing .Phd
Other areas of specialty/work
Street address
Velayat complex, Artesh Sq, Shahid Langari St, Noboniad Sq
City
Tehran
Postal code
1615998741
Phone
+98 21 2612 7237
Fax
Email
s.najafi@bmsu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University of medical sciences Baqiyatallah
Full name of responsible person
Ali Ahmadi Dastjerdi
Position
MSN
Other areas of specialty/work
Street address
Velayat complex, Artesh Sq, Shahid Langari St, Noboniad Sq
City
Tehran
Postal code
1615998741
Phone
+98 21 2612 7237
Fax
Email
ahmadid97@yahoo.com
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
Loading...