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Comparing the effect of a designed care program by cases without intervention on control of asthma and quality of life in 60 patients with asthma referring to selected clinics of Shiraz university of medical sciences

Protocol summary

Summary
This study is a randomized clinical trial on 60 patients with asthma in selected clinics in Shiraz (Faghihi and Motahary) was performed to evaluate the effect of designed care program on control of asthma and quality of life in patient with asthma. 2) Design: After obtaining informed consent, eligible patients were randomly assigned to two groups: education with rehabilitation and control groups. Methods: before intervention we measured basic test with asthma Control Questionnaire, Quality of Life Questionnaire and peak flow meter in two groups. The interventional group received care programs that include education about asthma and its treatment and rehabilitation was done during one month. Then, immediately and two months after the intervention, two groups were evaluated. During this period, the control group received no intervention. Inclusion criteria: patients with asthma, age range 19 -65 years, Failure to participate in similar programs in the past 6 months, Absence of other known chronic condition that requires special care and different programs. Exclusion criteria were: having muscle problems-bone defects, heart disease-cardiovascular diseases, pregnancy or acute diseases that may be incompatible with the exercise, lack of cooperation and participation in the study and absence of two or more training sessions 6) Interventions: asthma education, rehabilitation and exercise techniques under the expert supervision.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014041617299N1
Registration date: 2014-12-19, 1393/09/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-12-19, 1393/09/28
Registrant information
Name
Masumeh Zarei
Name of organization / entity
Shiraz University Medical of Siences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4254
Email address
zarei_ma@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2014-01-21, 1392/11/01
Expected recruitment end date
2014-06-21, 1393/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of a designed care program by cases without intervention on control of asthma and quality of life in 60 patients with asthma referring to selected clinics of Shiraz university of medical sciences
Public title
Effect of care program on Asthma control and quality of life
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 1) patients with asthma disease after approval by the relevant specialist. 2) In asthmatic patients, age range 19 -65 years. 3) they wish to participate in the study. 4) Failure to participate in similar programs in the past 6 months. 5) absence of other known chronic condition that requires special care and different programs. Exclusion criteria were: 1) having muscle problems, bone defects, heart disease - cardiovascular diseases, pregnancy or acute diseases that may be incompatible with the exercise. 2) lack of cooperation and participation in the study. 3) absence of two or more training sessions.
Age
From 19 years old to 65 years old
Gender
Both
Phase
N/A
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
Parallel
Other design features
Block randomization method is presented.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences Ethics Committee
Street address
Vice Chancellor for Research, 7th floor, Central Building of Shiraz University of Medical Sciences, Zand Street, Shiraz.
City
Shiraz
Postal code
1978-71345
Approval date
2014-01-15, 1392/10/25
Ethics committee reference number
6851

Health conditions studied

1

Description of health condition studied
Asthma
ICD-10 code
j45
ICD-10 code description
asthma

Primary outcomes

1

Description
Asthma Control
Timepoint
Before the intervention, immediately after intervention, two Months after treatment
Method of measurement
Peak flow meter, Asthma Control Test

2

Description
Quality of life
Timepoint
Before the intervention, immediately after intervention and two months after treatment
Method of measurement
Asthma Quality of Life Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The rehabilitation-educational classes were held according to pre-recorded training schedule for the intervention group as 4-6 sessions of 60 minutes for one month (depending on training needs, understanding of each individual and their educational level, the length of the class time may increase). Educational items include: understanding the disease and its pathophysiology, allergens, drug treatments and their side effects, using spray correctly and teaching effective coughing, effective exercise techniques, and self-care. In addition, pulmonary rehabilitation was provided under the supervision of a specialist in physical medicine as moderate-intensity aerobic exercise 6-5 days per week, each time 30 minutes for large muscle groups and correct posture and contraction of the shoulder, shrugging and rotating of shoulders, stretching the shoulder girdle, spinal cord, and intercostals muscles, exercising deep breath and holding it, along with relaxation training. The participants were given pamphlets. Follow-up phone calls were conducted by the researcher to control their abeyance from the care program.
Category
Other

2

Description
The control group received routine care and education. Also at the end of the study, the control group also runs a training program and manual were awarded to them.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shiraz Motahari Clinic
Full name of responsible person
Masum Masumpoor
Street address
Namazi Square, Shiraz
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Gholamreza Hatam
Street address
Vice Chancellor for Research, 7th floor, Central Building of Shiraz University of Medical Sciences, Zand Street, Shiraz.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Molazem
Position
PHD in nursing
Other areas of specialty/work
Street address
Hazrat-e-Fatemeh nursing and midwifery College, Namazi Hospital, Namazi Square, Shiraz
City
Shiraz
Postal code
71345-1978
Phone
+98 71 1647 4254
Fax
+98 71 1627 9135
Email
Molazemzah@yahoo.com
Web page address
www.SUMS.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Molazem
Position
PHD of Nursing
Other areas of specialty/work
Street address
Fatemeh (p.b.u.h) School of Nursing and Midwifery, Namazi Hospital, Namazi Sq., Shiraz
City
Shiraz
Postal code
0098
Phone
+98 71 1647 4254
Fax
Email
Molazem@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Masumeh Zarei
Position
Master of Nursing
Other areas of specialty/work
Street address
Hazrat-e-Fatemeh Nursing and Midwifery College, Namazi Hospital, Namazi Sq., Shiraz
City
Shiraz
Postal code
7194685791
Phone
+98 72 2446 3290
Fax
Email
Masumehzarei67@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
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