Protocol summary

Summary
Shortness of breath and fatigue are two main symptom in COPD patients. Fatigue is an unpleasant feeling, which prevents tasks and role of the individual and social. Pulmonary rehabilitation is an effective method to reduce fatigue and promotion of quality of life in COPD patients. Breathing exercises are an important component of pulmonary rehabilitation. The nurses who look after the patients with lung obstruction can be efficient in fastening the recovery and promoting the health level by representing a list of these practices. The aim of this study is to determine the effect of breathing exercises on fatigue dimension chronic obstructive pulmonary disease patients. This research is an quasi- experimental design , clinical trial . The research units includes 70 patients suffering COPD in Razi Hospital .Inclusion criteria: confirming of Disease by a specialist and the results of diagnostic tests؛ Patients enter in study with stage two above؛ Absence of Underlying disease (including unstable angina؛ aortic valve disease؛ cardiac uncontrolled arrhythmia؛ uncontrolled hypertension؛ heart failure)؛ Absence of Known defects in the respiratory system caused of other diseases not consumption؛Fatigue-reducing drugs such as amantadine ؛ Literate and able to speak Persian؛ Possibility of contact by phone/mobile phone . Exclusion criteria: patients with progresses COPD disease ؛death of patients؛ enter to acute phase disease. .The patients were randomly assigned into experimental or control groups. The experimental group participated in a breathing exercises program. Then ,the patients will be asked to do breathing exercises 4 times a day for 10 days.The control group received only routine visits . both of groups received routine drugs. fatigue dimensions (general,physical,reduced activity,reduced motivation,mental fatigue) measured and compared in both groups

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201504111174N10
Registration date: 2015-05-16, 1394/02/26
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-05-16, 1394/02/26
Registrant information
Name
Atefeh Ghanbari
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13780509
Email address
at_ghanbari@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
vice chancellor for research , Guilan University of Medical Sciences
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2015-09-23, 1394/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of breathing exercises on the fatigue dimensions in patients with chronic obstructive pulmonary disease referred to RAZI educational therapeutic center
Public title
The effect of breathing exercises on the fatigue dimensions in patients with chronic obstructive pulmonary disease referred to RAZI educational therapeutic center .
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: confirming of Disease by a specialist and the results of diagnostic tests؛ Patients enter in study with stage two above؛ Absence of Underlying disease (including unstable angina؛ aortic valve disease؛ cardiac uncontrolled arrhythmia؛ uncontrolled hypertension؛ heart failure)؛ Absence of Known defects in the respiratory system caused of other diseases not consumption؛Fatigue-reducing drugs such as amantadine ؛ Literate and able to speak Persian؛ Possibility of contact by phone/mobile phone؛ Exclusion criteria: patients with progresses COPD disease ؛death of patients؛ enter to acute phase disease.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
no
Secondary trial Id
no
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Vice Chancellor for Research and Technology ,Guilan University of Medical Scienc
Street address
Research and Technology affairs building , infront of Bank Sepah , over of iran radiator , West Beheshti Boulevard ,Rasht
City
Rasht
Postal code
Approval date
2015-03-10, 1393/12/19
Ethics committee reference number
293/000/361/8

Health conditions studied

1

Description of health condition studied
Chronic Obstructive Pulmonary Disease.
ICD-10 code
j40 .j41,
ICD-10 code description
other chronic obstructive pulmonary disease

Primary outcomes

1

Description
Fatigue dimensions
Timepoint
Before and after intervention
Method of measurement
Multidimensional fatigue inventory

Secondary outcomes

1

Description
no
Timepoint
no
Method of measurement
no

Intervention groups

1

Description
Experimental group participated in a breathing exercises program The breathing exercises in this study consisted of Pursed- lip breathing,diaphragmatic breathing and effective cough.Researcher instruct the breathing exercises components in 1 parts of 30 minutes.Then ,the patients will be asked to do breathing exercises 4 times a day for 10 days. Researcher administer the breathing exercises of patients during they hospitalized.The patient complete breathing exercises by using self-reporting forms After discharge. Telephone Follow-up program that consisted encourage patients to continue the performance,reinforcement of education, and answers to the patient questions education daily.
Category
Rehabilitation

2

Description
The control group received only routine visits and, no such intervention does not take place .
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
RAZI educational therapeutic center
Full name of responsible person
Atefeh Ghanbari
Street address
Nursing and midwiffery school ,St Student ,Beheshti Highway, Rasht
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology ,Guilan University of Medical Sciences
Full name of responsible person
Abtin Heidar Zadeh
Street address
Research and Technology affairs building ,infront of Bank Sepah ,over of iran radiator ,West Beheshti Boulevard ,Rasht
City
Rasht
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 and Technology ,Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Atefeh Ghanbari
Position
PHD
Other areas of specialty/work
Street address
Nursing and midwiffery school ,St Student ,Beheshti Highway, Rasht
City
Rasht
Postal code
39841-41469
Phone
+98 13 3355 3202
Fax
+98 13 3355 0097
Email
at_ghanbari@gums.ac.ir
Web page address
www.gums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University Of Medical Sciences
Full name of responsible person
Atefeh Ghanbari
Position
PHD
Other areas of specialty/work
Street address
Nursing and midwiffery school ,St Student ,Beheshti Highway, Rasht
City
Rasht
Postal code
39841-41469
Phone
+98 13 3355 3202
Fax
+98 13 3355 0097
Email
at_ghanbari@gums.ac.ir
Web page address
www.gums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Guilan University Of Medical Sciences
Full name of responsible person
Atefeh Ghanbari
Position
PHD
Other areas of specialty/work
Street address
Nursing and midwiffery school ,St Student ,Beheshti Highway, Rasht
City
Rasht
Postal code
39841-41469
Phone
+98 13 3355 3202
Fax
+98 13 3355 0097
Email
at_ghanbari@gums.ac.ir
Web page address
www.gums.ac.ir

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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