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comparison the effects of chest physiotherapy and breathing exercises on fatigue and daily activities in patients with Chronic Obstructive Pulmonary Disease.

Protocol summary

Summary
This is a randomized clinical trial study to determine and comparison the effects of chest physiotherapy and breathing exercises on fatigue and daily activities in patients with Chronic obstructive Pulmonary Disease(COPD). fifty one patients with COPD will be divided randomly in three groups of chest physiotherapy (group 1) , breathing exercises (group2), chest physiotherapy and breathing exercises ( group 3). Inclusion criteria are: filled in patients consent, definite diagnosis of COPD, aged 40-65, lack of diagnosed mental disorders, no other chronic and disabling disease like heart failure and lung cancer which have Confounding effects on the study. Exclusion criteria are: no more tendency to continue the study, disability to do recommended chest physiotherapy and breathing exercises, exacerbations during hospitalization, emigration and death. Population of the study is all COPD patients who have been admitted at internal wards of hospitals in Yasuj. Total sample size is 51 patients who will be divided in 3 groups (each group 17 patients). Interventions for group 1: chest physiotherapy 3 times a day for 10 days, group 2: breathing exercises 3 times a day for 10 days, and group 3: both interventions (chest physiotherapy and breathing exercises) 3 times a day for 10 days. Data will be collected before interventions, 1 and 2 weeks after interventions. Primary outcomes are fatigue and daily activities of COPD patients.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015082923804N1
Registration date: 2015-12-30, 1394/10/09
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-12-30, 1394/10/09
Registrant information
Name
Sarayel Behzadinezhad
Name of organization / entity
Yasuj University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 74 3333 7371
Email address
behzadinya.sar@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Yasuj University of Medical Science
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison the effects of chest physiotherapy and breathing exercises on fatigue and daily activities in patients with Chronic Obstructive Pulmonary Disease.
Public title
Effect of pulmonary rehabilitation on fatigue and daily activities of patients with Chronic Obstructive Pulmonary Disease.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria are: filled in patients consent , definite diagnosis of Chronic Obstructive Pulmonary Disease , aged 40-65, lack of diagnosed mental disorders, no other chronic and disabling disease like heart failure and lung cancer which have Confounding effects on the study. Exclusion criteria are: no more tendency to continue the study, disability to do recommended chest physiotherapy and breathing exercises, exacerbations during hospitalization, emigration and death.
Age
From 40 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 51
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Fifty-one patients with Chronic Obstructive Pulmonary Disease will be randomly divided into three groups. ( simple random).

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
Research Management of Yasuj University of Medical Sciences, Research and Technology Deputy of Yasuj University of Medical Sciences, Shahid Motahary Blvd., Yasuj, Iran
City
Yasuj
Postal code
7591994799
Approval date
2015-08-26, 1394/06/04
Ethics committee reference number
Code of ethics: YUMS.REC.1394.76

Health conditions studied

1

Description of health condition studied
Chronic Obstructive Pulmonary Disease
ICD-10 code
J95-J99
ICD-10 code description
other disease of the respiratory system

Primary outcomes

1

Description
fatigue
Timepoint
Before intervention, A week after intervention, Two week after intervention.
Method of measurement
MFI-20 Questionnaire

2

Description
Activities of Daily Living
Timepoint
Before intervention, A week after intervention, Two week after intervention.
Method of measurement
ADL- QUESTIONNARE

Secondary outcomes

1

Description
havenot
Timepoint
havenot
Method of measurement
havenot

Intervention groups

1

Description
Intervention1: In chest physiotherapy group interventions will be done by nurse and 3 times a day for 10 minutes while last for 10 days from admission. Patients will be in different positions and will be tapped with cup-shaped hand and palmar vibration. It will be done in patient's room and on his/her bed.
Category
Rehabilitation

2

Description
Intervention2: In breathing exercise group interventions (pursed lip and diaphragmatic respiration, inflating balloon or plastic bag) will be done 3 times a day for 15 minutes while last for 10 days from admission.
Category
Rehabilitation

3

Description
Intervention3: in group 3 all interventions in groups 1 and 2 will be done for patients 3 times a day for 10 days from admission.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Sajad Hospital
Full name of responsible person
Dr Ardashir Afrasiabifar
Street address
Nursing and Midwifery College, Shahid Dr. Jalil St., Yasuj
City
Yasuj

2

Recruitment center
Name of recruitment center
Beheshti Hospital
Full name of responsible person
Dr Ardashir Afrasyabifar
Street address
Nursing and Midwifery College, Shahid Dr. Jalil St., Yasuj
City
Yasuj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Yasuj University of Medical Sciences
Full name of responsible person
Doctor Mehdi Akbartabar turi
Street address
Research Management of Yasuj University of Medical Sciences, Research and Technology Deputy of Yasuj University of Medical Sciences, Shahid Motahary Blvd., Yasuj, Iran
City
Yusuj
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,Yasuj 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
Yasuj University of Medical Sciences
Full name of responsible person
Dr. Ardashir Afrasiabifar
Position
Ph.D of Medical Surgical Nursing- Associate Professor
Other areas of specialty/work
Street address
Nursing and Midwifery College, Shahid Dr. Jalil St., Yasuj
City
Yasuj
Postal code
Phone
+98 74 3323 5141
Fax
Email
afrasiabifar@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasuj University of Medical Science
Full name of responsible person
Dr Ardeshir Afrasiabifar
Position
Ph.D of Medical Surgical Nursing- Associate Professor
Other areas of specialty/work
Street address
Nursing and Midwifery College, Shahid Dr. Jalil St., Yasuj
City
Yasuj
Postal code
7591994799
Phone
+98 74 3323 5141
Fax
Email
afrasiabifar@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Yasuj University of Medical Science
Full name of responsible person
Sarayel Behzadinezhad
Position
MS student of Medical Surgical Nursing
Other areas of specialty/work
Street address
Nursing and Midwifery College, Shahid Dr. Jalil St., Yasuj
City
Yasuj
Postal code
7591994799
Phone
+98 74 3323 5141
Fax
Email
behzadinya.sar@yums.ac.ir; sa.behzadinezhad@gmail.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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