Identify effect of pulmonary rehabilitation program on respiratory disorders and quality of life in chemical victims, Sardasht, Iran
Design
After random allocation, the researcher in the intervention group will need an assessment based on the health status forms from the intervention group. Then, based on the problems with nutritional reform, activities, the correct use of medication, respiratory physiotherapy and rehabilitation exercises will be taught to them. Trained athletic exercises will be conducted daily for two months at home and with researcher follow up. In the control group, quality of life questionnaire and visual instrumentation, the severity of shortness of breath will be completed concurrently with the intervention group.
Settings and conduct
Khatam Al Anbia Sardasht Clinic of Chemical Injuries is affiliated with the Martyr Foundation and the Affaires. The city's chemical casualties are referred to as the first line of health care services.
Participants/Inclusion and exclusion criteria
Chemical injuries suffered from chronic pulmonary insufficiency referring to Sardasht chemical injury clinic
Intervention groups
After random allocation, the researcher in the intervention group will need an assessment based on the health status forms from the intervention group. Then, based on the problems with nutritional reform, activities, the correct use of medication, respiratory physiotherapy and rehabilitation exercises will be taught to them. Trained athletic exercises will be conducted daily for two months at home and with researcher follow up.
Main outcome variables
With the implementation of the pulmonary rehab program, the participants' respiratory problems have been reduced and quality of life related to health has been improved.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141124020064N2
Registration date:2019-01-28, 1397/11/08
Registration timing:retrospective
Last update:2019-01-28, 1397/11/08
Update count:0
Registration date
2019-01-28, 1397/11/08
Registrant information
Name
Fereydoon Khayeri
Name of organization / entity
Iran University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1000
Email address
khayeri.f@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-06-21, 1396/03/31
Actual recruitment start date
2017-05-22, 1396/03/01
Actual recruitment end date
2017-06-21, 1396/03/31
Trial completion date
2017-11-13, 1396/08/22
Scientific title
Effect of pulmonary rehabilitation program on respiratory disorders and quality of life in chemical victims, Sardasht
Public title
Effect of pulmonary rehabilitation program on respiratory disorders and quality of life in chemical victims, Sardasht, Iran
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Moderate to severe COPD
َAble to cooperate in pulmonary rehabilitation program
Writing and reading ability
Not having mental or psychological illness
No history of pulmonary disease before mustard exposure
Non smoker
Exclusion criteria:
Exit from study
No cooperation in 1 of education class
Increase of pulmonary disorders or decrease of FEV1 less than 30%
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Actual sample size reached:
76
Randomization (investigator's opinion)
Randomized
Randomization description
The allocation of people in the two groups will be randomly based on a random selection of random numbers. In this way, before and after the study, AB and AB randomized permutations are defined as control (A) and intervention (B) groups. Using a random number table of half the sample size, the single digit number is selected between zero and nine. The odd number will be the selection of two people in the AB group and the pair number will mean two people in the BA groups. In this way, a sequence of AB and BA will be selected, which will be the same for the two groups. On the other hand, the layout will be completely random and it will not be easy to determine which group to be grouped into.
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
Iran University of Medical Sciences Ethical Committee
Street address
Rashid Yasemi St., Vali-e-Asr St.
City
Tehran
Province
Tehran
Postal code
1996713883
Approval date
2019-01-21, 1397/11/01
Ethics committee reference number
IR.IUMS.REC.1397.878
Health conditions studied
1
Description of health condition studied
Respiratory Disorders
ICD-10 code
j44
ICD-10 code description
COPD
Primary outcomes
1
Description
Reducing respiratory problems means that pulmonary volumes increase and dyspnea is reduced. An increase in the quality of life score that reflects its improvement.
Timepoint
2 month
Method of measurement
St George Respiratory Questionnaire, Spirometery, 6 Minute Walking Test, Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
First, after obtaining the consent and willingness of the injured to participate in the research, the questionnaires are completed and the preliminary data are collected. For each Individuals in the intervention group, the informed consent form will be filled out. Each participant first completed a demographic questionnaire form including the name (optional), age, gender, injury history, marital status, smoking and tobacco, education, job status, and income, and then a form of review of the quality of life of the St George will fill out a quality of life questionnaire for respiratory diseases.Self-reporting questionnaire for chronic lung patients is standardized and the time required to complete 10 minute. This questionnaire has 50 questions and 3 distentions. The sections include symptoms, activity, and impact on daily life. Questions are scanned from 0 to 100 and expressed as percentages. The higher the score, the worse the quality of life. The questionnaire will be completed again two months after the intervention.Participants are also asked to record their shortness of breath. The intensity of shortness of breath is measured by the Visual Analog Scale instrument once a month. This instrument is a visual instrument for measuring the degree of shortness of breath in the range of 0 to 100 mm. The zero number indicates that there is no shortness of breath and the number of 100 represents the maximum severity of the breathlessness. This tool will be completed again two months after the intervention. Then, from each of the Individuals in the intervention group, spirometery will be performed to determine the pulmonary function. Spirometry will be re-sampled two months later. Each participant is then asked to complete the six minute gap test. In this test, each sample is asked to walk for six minutes and the area traveled by each person will be recorded.The distance traveled will be measured again after two months And increasing the distance up to 54 meter will be a significant change.
Category
Rehabilitation
2
Description
Control group: After receiving the consent and willingness of the injured to participate in the research, the questionnaires are completed and the preliminary data are collected. For each research unit, the informed consent form will be filled out. Each person in the control group first completed a demographic questionnaire containing the name (optional), age, sex, injury history, marital status, smoking and tobacco, education, job status and income, and then a quality of life assessment form St. George fill in. The questionnaire will be completed again two months later.Participants are also asked to record their shortness of breath. The intensity of shortness of breath is measured by the VAS tool once a month. The tool will be completed again two months later. Then, each spirometric control group will be assigned to determine pulmonary function. Spirometery will be re-sampled two months later. Then, each of the control group samples are asked to complete the six minute interval test. In this test, each specimen is asked to walk for six minutes and the area traveled by each person will be recorded.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of chemical victims Khatam-ol-Anbia Sardasht
Full name of responsible person
Mostafa Omari
Street address
Hiroshima St.
City
Sardaht
Province
West Azarbaijan
Postal code
5961631455
Phone
+98 44 4433 5594
Fax
+98 44 4432 5662
Email
sulaymanqadiri@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Masumeh Kheirkhah
Street address
Rashid yasemi, Vali-e- Asr
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1708
Fax
+98 21 8820 1978
Email
kheirkhah.m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Fereydoun Khayyeri
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hemmat Highway, Below the Milad Tower
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 1000
Fax
+98 21 8670 1000
Email
adminsite@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sulayman Ghaderi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Hemmat Highway - next to Milad Tower
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 1000
Fax
+98 21 8670 1000
Email
sulaymanqadiri@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sulayman Ghaderi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Hemmat Highway - next to Milad Tower
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 1000
Fax
+98 21 8670 1000
Email
sulaymanqadiri@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The results of the research will be published as a scientific paper. The results will be announced to the beneficiary organizations.
When the data will become available and for how long
1 year
To whom data/document is available
Vice-Chancellor's Office for Research
Under which criteria data/document could be used
evaluation
From where data/document is obtainable
Vice-Chancellor's Office for Research
What processes are involved for a request to access data/document